30 Quality Assurance Roles jobs in Plymouth
Senior Pharmaceutical Quality Control Analyst
PL1 2AB Plymouth, South West
£40000 Annually
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Posted 2 days ago
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Job Description
Our client, a leading pharmaceutical company dedicated to innovation and quality, is seeking a highly skilled Senior Pharmaceutical Quality Control Analyst to join their state-of-the-art laboratory facility in Plymouth, Devon, UK . This critical role involves ensuring the quality and integrity of pharmaceutical products through rigorous testing and analysis. You will be responsible for performing a wide range of analytical tests on raw materials, in-process samples, and finished products using advanced laboratory equipment. The ideal candidate will possess a strong foundation in analytical chemistry, pharmaceutical regulations, and quality control principles. You will be expected to interpret test results, troubleshoot analytical issues, and maintain detailed records in compliance with Good Manufacturing Practices (GMP) and regulatory guidelines. This position requires meticulous attention to detail, a strong understanding of analytical techniques (e.g., HPLC, GC, spectroscopy), and the ability to work effectively both independently and as part of a collaborative QC team. You will also play a role in method development and validation, as well as contributing to continuous improvement initiatives within the QC department. Experience with regulatory inspections and a solid understanding of quality assurance systems are essential. This is an excellent opportunity for an experienced QC professional looking to advance their career within a reputable pharmaceutical organization committed to developing life-saving medicines. The company offers a supportive work environment, opportunities for professional growth, and a competitive benefits package. You will be instrumental in upholding the highest standards of product quality and patient safety. The role demands a rigorous approach to scientific methodology and a commitment to excellence in every aspect of the work.
Key Responsibilities:
Key Responsibilities:
- Perform a variety of analytical tests on raw materials, intermediates, and finished products using techniques such as HPLC, GC, UV-Vis, FTIR, and dissolution testing.
- Develop, validate, and transfer analytical methods according to regulatory guidelines.
- Interpret test data, evaluate results against specifications, and document findings accurately.
- Investigate Out-of-Specification (OOS) results and deviations, participating in root cause analysis.
- Maintain laboratory equipment, ensuring calibration and proper functioning.
- Adhere strictly to GMP, GLP, and other relevant regulatory requirements.
- Prepare and review analytical test reports, batch release documentation, and other quality records.
- Collaborate with R&D, manufacturing, and regulatory affairs departments.
- Contribute to the continuous improvement of QC processes and laboratory operations.
- Participate in internal and external audits and inspections.
- Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
- Minimum of 5 years of experience in pharmaceutical quality control or analytical development.
- Proficiency in a wide range of analytical techniques, including HPLC and GC.
- In-depth knowledge of GMP, ICH guidelines, and regulatory requirements for pharmaceuticals.
- Experience with method validation and qualification.
- Strong understanding of data integrity principles.
- Excellent problem-solving, critical thinking, and documentation skills.
- Ability to work independently and as part of a team in a fast-paced laboratory environment.
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0
Senior Pharmaceutical Quality Control Analyst
PL5 1QH Plymouth, South West
£40000 Annually
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Posted 2 days ago
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Job Description
We are seeking a highly skilled and dedicated Senior Pharmaceutical Quality Control Analyst to join a leading pharmaceutical company based in Plymouth, Devon, UK . The successful candidate will be responsible for ensuring the quality and integrity of pharmaceutical products through rigorous testing and analysis. This role demands meticulous attention to detail, a strong understanding of analytical techniques, and adherence to strict regulatory guidelines.
Key Responsibilities:
Key Responsibilities:
- Perform a wide range of analytical tests on raw materials, intermediates, and finished products using various laboratory techniques (e.g., HPLC, GC, spectroscopy, wet chemistry).
- Develop, validate, and transfer analytical methods according to relevant guidelines (e.g., ICH, USP, EP).
- Analyze and interpret test results, ensuring accuracy and completeness.
- Document all laboratory activities, including test procedures, results, and deviations, in compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
- Investigate out-of-specification (OOS) results and out-of-trend (OOT) data, identifying root causes and implementing corrective and preventive actions (CAPAs).
- Maintain laboratory equipment, ensuring it is calibrated, qualified, and in good working order.
- Contribute to the preparation of regulatory submission documents and respond to queries from health authorities.
- Train and mentor junior analysts, providing guidance on analytical techniques and laboratory procedures.
- Participate in internal and external audits, ensuring compliance with regulatory standards.
- Collaborate with other departments, including R&D, Manufacturing, and Regulatory Affairs, to resolve quality issues.
- Stay updated on current industry trends, scientific advancements, and regulatory changes affecting pharmaceutical quality control.
- Ensure the safe handling and disposal of chemicals and laboratory waste.
- A Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
- A minimum of 5 years of hands-on experience in a pharmaceutical Quality Control laboratory.
- Proficiency in analytical techniques such as HPLC, GC, UV-Vis, FTIR, and dissolution testing.
- Strong understanding of GMP, GLP, and relevant regulatory guidelines (e.g., ICH, FDA, EMA).
- Experience with method development and validation is essential.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong documentation and report-writing abilities.
- Good communication and interpersonal skills, with the ability to work effectively in a team.
- Experience with laboratory information management systems (LIMS) is a plus.
- The ability to work independently and as part of a collaborative team in a laboratory setting.
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1
Senior Pharmaceutical Quality Control Analyst
PL2 1AA Plymouth, South West
£40000 Annually
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Posted 2 days ago
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Job Description
Our client, a leading pharmaceutical company, is seeking an experienced Senior Pharmaceutical Quality Control Analyst to join their dedicated team in Plymouth, Devon, UK . This hybrid role offers a blend of on-site laboratory work and remote data analysis, providing a balanced working environment. You will play a critical role in ensuring the quality, safety, and efficacy of our pharmaceutical products through rigorous testing and analysis. Your meticulous attention to detail and deep understanding of analytical techniques will be essential in maintaining our high standards.
Responsibilities:
Responsibilities:
- Perform a wide range of analytical tests on raw materials, in-process samples, and finished pharmaceutical products using various laboratory techniques (e.g., HPLC, GC, UV-Vis, FTIR, titration).
- Develop, validate, and implement new analytical methods according to regulatory guidelines (e.g., ICH, GMP).
- Troubleshoot and maintain analytical instrumentation, ensuring accuracy and reliability of results.
- Interpret test results, prepare comprehensive analytical reports, and document all activities in compliance with Good Manufacturing Practices (GMP).
- Investigate out-of-specification (OOS) results and deviations, recommending corrective and preventive actions (CAPAs).
- Collaborate with R&D, production, and regulatory affairs teams to support product development and lifecycle management.
- Mentor and train junior analysts, providing technical guidance and support.
- Participate in internal and external audits, ensuring compliance with quality standards.
- Contribute to the continuous improvement of quality control processes and laboratory operations.
- Manage and maintain laboratory consumables and reagents inventory.
- BSc or MSc in Chemistry, Pharmaceutical Sciences, or a related discipline.
- Minimum of 5 years of experience in pharmaceutical quality control or analytical development.
- Proficiency in operating and maintaining analytical instruments such as HPLC, GC, and spectrophotometers.
- Strong knowledge of GMP, ICH guidelines, and regulatory requirements for pharmaceutical testing.
- Excellent analytical, problem-solving, and documentation skills.
- Ability to work independently and as part of a team in a fast-paced environment.
- Experience with method validation and transfer is essential.
- Good communication skills, both written and verbal.
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2
Senior Pharmaceutical Quality Control Analyst - Remote
PL1 2AX Plymouth, South West
£50000 Annually
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Posted 2 days ago
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Job Description
Our client, a renowned pharmaceutical company committed to delivering high-quality medicines, is seeking a meticulous and experienced Senior Pharmaceutical Quality Control Analyst to join their remote team. This position offers the flexibility to work from home, contributing essential expertise to ensure the integrity and compliance of pharmaceutical products. You will be responsible for performing a wide range of analytical tests on raw materials, in-process samples, and finished products, adhering to strict Good Manufacturing Practices (GMP) and regulatory guidelines. Your role is critical in safeguarding product quality and patient safety.
The ideal candidate will possess a strong background in analytical chemistry and extensive experience with various laboratory techniques and instrumentation common in the pharmaceutical industry, such as HPLC, GC, UV-Vis spectroscopy, and dissolution testing. You will be adept at method validation, data interpretation, and troubleshooting analytical issues. This role requires an individual with exceptional attention to detail, strong problem-solving capabilities, and the ability to maintain accurate and thorough documentation. Collaboration with cross-functional teams, including R&D, manufacturing, and regulatory affairs, will be integral to your success. You will also play a role in ensuring the team remains up-to-date with evolving regulatory landscapes.
Key Responsibilities:
Qualifications:
This is a fantastic opportunity for a seasoned QC professional to contribute their expertise to a leading pharmaceutical organization while enjoying the benefits of a remote working arrangement.
The ideal candidate will possess a strong background in analytical chemistry and extensive experience with various laboratory techniques and instrumentation common in the pharmaceutical industry, such as HPLC, GC, UV-Vis spectroscopy, and dissolution testing. You will be adept at method validation, data interpretation, and troubleshooting analytical issues. This role requires an individual with exceptional attention to detail, strong problem-solving capabilities, and the ability to maintain accurate and thorough documentation. Collaboration with cross-functional teams, including R&D, manufacturing, and regulatory affairs, will be integral to your success. You will also play a role in ensuring the team remains up-to-date with evolving regulatory landscapes.
Key Responsibilities:
- Perform analytical testing on raw materials, intermediates, and finished pharmaceutical products using various instrumentation (e.g., HPLC, GC, UV-Vis, FTIR).
- Develop, validate, and transfer analytical methods according to regulatory requirements.
- Interpret analytical data, document results accurately, and generate certificates of analysis.
- Troubleshoot and resolve analytical issues encountered during testing.
- Ensure all laboratory activities comply with GMP, ICH guidelines, and other relevant regulatory standards.
- Maintain laboratory equipment and ensure calibration and qualification status.
- Prepare technical reports, summaries, and responses to regulatory inquiries.
- Collaborate with manufacturing and R&D departments to support product development and troubleshooting.
- Contribute to the continuous improvement of QC processes and procedures.
- Stay informed about advancements in analytical techniques and pharmaceutical regulations.
Qualifications:
- Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
- Minimum of 5 years of experience in pharmaceutical quality control or analytical development.
- Extensive hands-on experience with analytical techniques such as HPLC, GC, dissolution testing, and spectroscopy.
- Strong understanding of GMP, ICH guidelines, and pharmaceutical regulatory requirements.
- Proven ability to validate analytical methods and troubleshoot instrumentation.
- Meticulous attention to detail and excellent record-keeping skills.
- Strong problem-solving and critical thinking abilities.
- Proficiency in using laboratory information management systems (LIMS).
- Excellent written and verbal communication skills.
- Ability to work independently and effectively manage time in a remote work environment.
This is a fantastic opportunity for a seasoned QC professional to contribute their expertise to a leading pharmaceutical organization while enjoying the benefits of a remote working arrangement.
This advertiser has chosen not to accept applicants from your region.
3
Principal Pharmaceutical Quality Assurance Specialist
PL5 1AD Plymouth, South West
£75000 Annually
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Our client, a globally recognized leader in pharmaceutical innovation, is seeking a highly experienced Principal Pharmaceutical Quality Assurance Specialist to join their esteemed, fully remote team. This senior role is critical in ensuring the highest standards of quality and compliance across all pharmaceutical development and manufacturing processes. You will be instrumental in developing, implementing, and maintaining robust Quality Management Systems (QMS) that adhere to stringent global regulatory requirements, including FDA, EMA, and MHRA guidelines. Your expertise will guide the organization in ensuring the safety, efficacy, and quality of pharmaceutical products from concept to market.
As a Principal Specialist, you will lead complex quality assurance initiatives, conduct thorough internal and external audits, and provide expert guidance on GMP (Good Manufacturing Practice) principles. You will analyze quality data, identify trends, investigate deviations and non-conformances, and implement effective corrective and preventive actions (CAPAs). This role requires a deep understanding of pharmaceutical manufacturing processes, regulatory affairs, and quality risk management. You will collaborate closely with cross-functional teams, including R&D, manufacturing, regulatory affairs, and validation, to foster a culture of quality throughout the organization. The ability to influence stakeholders and drive continuous improvement in quality systems is paramount. This is a fantastic opportunity to leverage your extensive QA experience in a flexible, remote-first environment, contributing significantly to the delivery of life-changing medicines.
Key Responsibilities:
As a Principal Specialist, you will lead complex quality assurance initiatives, conduct thorough internal and external audits, and provide expert guidance on GMP (Good Manufacturing Practice) principles. You will analyze quality data, identify trends, investigate deviations and non-conformances, and implement effective corrective and preventive actions (CAPAs). This role requires a deep understanding of pharmaceutical manufacturing processes, regulatory affairs, and quality risk management. You will collaborate closely with cross-functional teams, including R&D, manufacturing, regulatory affairs, and validation, to foster a culture of quality throughout the organization. The ability to influence stakeholders and drive continuous improvement in quality systems is paramount. This is a fantastic opportunity to leverage your extensive QA experience in a flexible, remote-first environment, contributing significantly to the delivery of life-changing medicines.
Key Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS) in alignment with global regulatory standards (e.g., GMP, ICH guidelines).
- Lead and conduct internal and external audits of suppliers, contract manufacturers, and internal departments.
- Investigate deviations, out-of-specification (OOS) results, and customer complaints, ensuring timely and effective CAPA implementation.
- Review and approve critical quality documents, including batch records, validation protocols, and change controls.
- Provide expert guidance and training on GMP compliance and quality assurance principles to relevant teams.
- Analyze quality metrics, identify systemic issues, and drive continuous improvement initiatives.
- Represent the Quality Assurance department in cross-functional project teams and regulatory inspections.
- Stay current with evolving regulatory requirements and industry best practices.
- Master's degree or Ph.D. in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 8-10 years of progressive experience in pharmaceutical Quality Assurance/Quality Control.
- Extensive knowledge of GMP regulations, ICH guidelines, and global pharmaceutical regulatory requirements.
- Proven experience in conducting audits, investigations, and managing CAPAs.
- Strong analytical, problem-solving, and critical thinking skills.
- Excellent written and verbal communication skills, with the ability to effectively communicate complex quality concepts.
- Demonstrated ability to lead projects and influence cross-functional teams.
- Experience with pharmaceutical product development and manufacturing processes.
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4
Senior Pharmaceutical Quality Assurance Specialist
PL1 2NE Plymouth, South West
£50000 Annually
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Posted 2 days ago
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Job Description
Our client, a dynamic and growing pharmaceutical company, is seeking a dedicated and meticulous Senior Pharmaceutical Quality Assurance Specialist to join their team in Plymouth, Devon, UK . This role is crucial in ensuring that all products meet the highest standards of quality, safety, and efficacy, adhering strictly to Good Manufacturing Practices (GMP) and regulatory requirements. The Senior QA Specialist will be responsible for developing, implementing, and maintaining the company's quality management system, conducting internal audits, managing deviations, and ensuring compliance throughout the product lifecycle. This hybrid position offers a blend of on-site collaboration and remote flexibility.
Key Responsibilities:
Qualifications and Skills:
Key Responsibilities:
- Develop, implement, and maintain the Quality Management System (QMS) in accordance with GMP guidelines and regulatory expectations.
- Conduct internal audits and support external regulatory inspections (e.g., MHRA, FDA).
- Manage and investigate deviations, CAPAs (Corrective and Preventive Actions), and change controls.
- Review and approve batch records, validation protocols, and reports.
- Ensure compliance with all relevant pharmaceutical regulations and industry standards.
- Provide training on quality systems and GMP principles to relevant personnel.
- Participate in supplier qualification and audits.
- Monitor quality metrics and KPIs, reporting on trends and identifying areas for improvement.
- Review and approve technical documents, including SOPs, specifications, and test methods.
- Act as a key point of contact for quality-related inquiries.
- Support product development and commercialization by ensuring quality considerations are addressed.
- Contribute to risk assessments and quality risk management activities.
- Maintain up-to-date knowledge of regulatory guidelines and industry best practices.
Qualifications and Skills:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. Master's degree is a plus.
- Minimum of 5 years of experience in Quality Assurance within the pharmaceutical industry.
- In-depth knowledge of GMP, ICH guidelines, and relevant regulatory frameworks.
- Proven experience in auditing, deviation management, and CAPA implementation.
- Strong understanding of pharmaceutical manufacturing processes and quality control.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional attention to detail and accuracy.
- Strong written and verbal communication skills.
- Proficiency in using quality management software and standard office applications.
- Ability to work effectively both independently and as part of a team.
- Experience with sterile manufacturing or biologics is advantageous.
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5
Lead Pharmaceutical Quality Assurance Specialist
PL4 0AA Plymouth, South West
£60000 Annually
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Posted 2 days ago
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Job Description
Our client, a distinguished pharmaceutical research and manufacturing company, is seeking a highly skilled and meticulous Lead Pharmaceutical Quality Assurance Specialist to join their dedicated team. This role is integral to ensuring that all products meet the highest standards of quality, safety, and regulatory compliance. You will play a critical role in maintaining and improving our robust quality management systems. Responsibilities:
- Develop, implement, and manage the company's Quality Management System (QMS) in accordance with regulatory requirements (e.g., GMP, GDP, ISO).
- Oversee and conduct internal and external audits to ensure compliance and identify areas for improvement.
- Review and approve batch records, validation protocols, and other quality-related documentation.
- Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPAs).
- Collaborate with R&D, Manufacturing, and Regulatory Affairs departments to ensure quality is embedded throughout the product lifecycle.
- Train and mentor junior QA personnel, fostering a strong quality culture within the organization.
- Stay abreast of evolving regulatory requirements and industry best practices in pharmaceutical quality assurance.
- Manage supplier qualification programs and ensure the quality of incoming materials.
- Prepare for and participate in regulatory inspections by agencies such as the MHRA, FDA, and EMA.
- Contribute to the continuous improvement of quality processes and systems.
- Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
- Minimum of 5 years of experience in pharmaceutical Quality Assurance or Quality Control.
- In-depth knowledge of Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other relevant regulatory guidelines.
- Proven experience with QMS, audits, deviations, OOS investigations, and CAPA management.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent attention to detail and organizational abilities.
- Proficient in written and verbal communication, with the ability to document findings clearly and concisely.
- Experience with electronic QMS software is advantageous.
- Ability to work effectively both independently and as part of a cross-functional team.
This advertiser has chosen not to accept applicants from your region.
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6
Senior Pharmaceutical Quality Assurance Specialist
PL1 2AG Plymouth, South West
£65000 Annually
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Posted 2 days ago
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Job Description
Our client, a respected name in the pharmaceutical industry, is looking for a Senior Pharmaceutical Quality Assurance Specialist to join their dedicated team. This is a fully remote role, offering the flexibility to work from anywhere in the UK, contributing to the critical oversight of quality systems. The successful candidate will be responsible for ensuring that all pharmaceutical products manufactured and distributed meet rigorous quality standards and comply with regulatory requirements (e.g., GMP, FDA, EMA). Your role will involve reviewing and approving batch records, deviations, change controls, and validation protocols. You will conduct internal audits and participate in external audits of suppliers and contract manufacturers. A key responsibility is to contribute to the continuous improvement of the Quality Management System (QMS), identifying potential risks and implementing corrective and preventive actions (CAPAs). The ideal candidate will possess a strong understanding of pharmaceutical manufacturing processes, quality control procedures, and regulatory guidelines. You will collaborate closely with R&D, manufacturing, regulatory affairs, and other departments to ensure quality is embedded throughout the product lifecycle.
We require an individual with excellent analytical, problem-solving, and critical thinking skills, coupled with meticulous attention to detail. Strong written and verbal communication skills are essential for documenting quality processes and interacting with internal teams and external regulatory bodies. Experience with quality risk management principles and data analysis for quality trends is highly desirable. This role offers an exciting opportunity to make a significant contribution to patient safety and product quality within a forward-thinking organisation that embraces remote work. If you are a dedicated QA professional with a passion for excellence and a desire to work in a flexible, remote environment, we encourage you to apply and help us uphold the highest standards in pharmaceutical manufacturing.
We require an individual with excellent analytical, problem-solving, and critical thinking skills, coupled with meticulous attention to detail. Strong written and verbal communication skills are essential for documenting quality processes and interacting with internal teams and external regulatory bodies. Experience with quality risk management principles and data analysis for quality trends is highly desirable. This role offers an exciting opportunity to make a significant contribution to patient safety and product quality within a forward-thinking organisation that embraces remote work. If you are a dedicated QA professional with a passion for excellence and a desire to work in a flexible, remote environment, we encourage you to apply and help us uphold the highest standards in pharmaceutical manufacturing.
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7
Senior Pharmaceutical Quality Assurance Specialist
PL1 1AA Plymouth, South West
£60000 Annually
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Posted 2 days ago
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Our client, a dynamic pharmaceutical company, is seeking a highly skilled Senior Pharmaceutical Quality Assurance Specialist to join their established team in **Plymouth, Devon, UK**. This critical role will ensure that all pharmaceutical manufacturing processes, products, and documentation comply with stringent regulatory standards, including GMP (Good Manufacturing Practice), ICH guidelines, and relevant health authority requirements. The successful candidate will be instrumental in maintaining and improving the company's Quality Management System (QMS), conducting audits, and supporting regulatory inspections. This position offers a significant opportunity to contribute to the delivery of high-quality medicinal products.
Key Responsibilities:
Qualifications and Skills:
Key Responsibilities:
- Oversee and manage quality assurance activities related to pharmaceutical manufacturing and product release.
- Ensure compliance with Good Manufacturing Practices (GMP) and other relevant regulatory requirements across all operations.
- Develop, implement, and maintain the company's Quality Management System (QMS).
- Conduct internal audits of manufacturing processes, quality systems, and documentation to identify and address non-compliance.
- Participate in external audits and inspections by regulatory authorities (e.g., MHRA, FDA) and customers.
- Review and approve batch records, validation protocols, and other critical quality documents.
- Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing effective corrective and preventive actions (CAPAs).
- Manage change control processes and assess the impact of changes on product quality.
- Train personnel on quality assurance principles, GMP, and regulatory compliance.
- Collaborate with cross-functional teams, including manufacturing, R&D, and regulatory affairs, to ensure quality standards are met.
- Stay up-to-date with evolving regulatory guidelines and industry best practices.
Qualifications and Skills:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 5-7 years of experience in Quality Assurance within the pharmaceutical or biotechnology industry.
- In-depth knowledge and practical experience with GMP, GDP, and regulatory guidelines (e.g., ICH, FDA, EMA).
- Proven experience in conducting internal audits and participating in regulatory inspections.
- Strong understanding of pharmaceutical manufacturing processes, quality control, and validation principles.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional attention to detail and accuracy.
- Strong written and verbal communication skills, with the ability to present complex information clearly.
- Experience with CAPA and change control systems.
- Ability to work independently and collaboratively within a team environment.
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8
Senior Pharmaceutical Quality Assurance Specialist
PL1 2JY Plymouth, South West
£55000 Annually
WhatJobs
Posted 2 days ago
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Job Description
A leading pharmaceutical company is seeking a highly experienced Senior Pharmaceutical Quality Assurance Specialist to join their dedicated remote team. This pivotal role will ensure adherence to stringent quality standards, regulatory requirements, and Good Manufacturing Practices (GMP) across all pharmaceutical development and manufacturing processes. You will be instrumental in maintaining the integrity and compliance of our products, contributing directly to patient safety and product efficacy. This is a remote-first position, offering the flexibility to work from anywhere while contributing to critical pharmaceutical operations.
Key Responsibilities:
Qualifications:
This role is a fully remote opportunity, allowing you to contribute from your chosen location. You will be an integral part of ensuring the highest standards of quality and compliance in the pharmaceutical sector. We offer a competitive compensation package, comprehensive benefits, and the chance to work with a world-class team on life-saving medications. If you are a highly motivated QA professional with a commitment to excellence, we encourage you to apply.
Key Responsibilities:
- Develop, implement, and maintain comprehensive Quality Assurance systems and procedures.
- Conduct internal and external audits of manufacturing facilities, suppliers, and processes to ensure compliance.
- Review and approve batch records, validation documents, and change controls.
- Investigate deviations, CAPAs (Corrective and Preventive Actions), and OOS (Out-of-Specification) results, implementing effective solutions.
- Participate in regulatory inspections and respond to inquiries from health authorities.
- Provide expert guidance on GMP, quality control, and regulatory compliance matters.
- Contribute to the continuous improvement of quality processes and systems.
- Train and mentor junior QA staff on quality principles and regulatory expectations.
- Review and approve product labeling and promotional materials for regulatory compliance.
- Stay current with evolving pharmaceutical regulations and industry best practices.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree or PhD is advantageous.
- Minimum of 7 years of progressive experience in Pharmaceutical Quality Assurance within the pharmaceutical industry.
- In-depth knowledge of GMP, ICH guidelines, and other relevant regulatory requirements (e.g., FDA, EMA).
- Proven experience in conducting audits, managing deviations, and implementing CAPAs.
- Excellent understanding of pharmaceutical manufacturing processes and quality control methodologies.
- Strong analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills, with the ability to articulate complex quality issues clearly.
- Experience in a remote work environment is essential.
- Ability to work independently and manage multiple priorities effectively.
- Professional certifications such as CQE, CQA, or similar are a strong plus.
This role is a fully remote opportunity, allowing you to contribute from your chosen location. You will be an integral part of ensuring the highest standards of quality and compliance in the pharmaceutical sector. We offer a competitive compensation package, comprehensive benefits, and the chance to work with a world-class team on life-saving medications. If you are a highly motivated QA professional with a commitment to excellence, we encourage you to apply.
This advertiser has chosen not to accept applicants from your region.
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