What Jobs are available for Quality Assurance in Gateshead?
Showing 37 Quality Assurance jobs in Gateshead
Quality Assurance Manager
NE1 1AA Newcastle upon Tyne, North East
£50000 Annually
WhatJobs
Posted 3 days ago
Job Viewed
Job Description
Our client, a leading name in the manufacturing sector, is seeking a highly experienced Quality Assurance Manager to oversee quality control processes at their facility in Newcastle upon Tyne, Tyne and Wear, UK . This critical role demands a rigorous approach to quality management, ensuring all products meet stringent internal and external standards. You will be responsible for developing, implementing, and maintaining the company's quality management system, driving continuous improvement, and fostering a culture of quality throughout the organization.
Responsibilities:
Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with relevant standards (e.g., ISO 9001).
- Oversee all quality assurance activities, including inspections, testing, and process audits.
- Establish quality control procedures and protocols for raw materials, in-process production, and finished goods.
- Lead and manage the QA team, providing training, guidance, and performance management.
- Investigate product defects and customer complaints, identifying root causes and implementing corrective and preventive actions (CAPA).
- Monitor key quality metrics and KPIs, reporting on performance to senior management.
- Collaborate with production, engineering, and R&D departments to ensure product quality and process consistency.
- Conduct internal audits and support external audits by customers and regulatory bodies.
- Ensure compliance with all relevant industry regulations and standards.
- Drive continuous improvement initiatives to enhance product quality and operational efficiency.
- Manage the calibration and maintenance of quality control equipment.
- Promote a strong quality-focused culture across all departments.
- Bachelor's degree in Engineering, Quality Management, or a related technical field.
- Minimum of 7 years of progressive experience in quality assurance or quality control within a manufacturing environment.
- Proven experience in developing and managing QMS, preferably with ISO 9001 certification.
- Strong understanding of statistical process control (SPC), root cause analysis, and CAPA methodologies.
- Excellent leadership, team management, and communication skills.
- Experience with various quality assurance tools and techniques.
- Proficiency in data analysis and reporting.
- Ability to work effectively with cross-functional teams.
- Strong problem-solving and decision-making skills.
- Familiarity with the manufacturing industry in Newcastle upon Tyne, Tyne and Wear, UK is a significant advantage.
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0
Principal Specialist, Quality Assurance (Design)
Newcastle upon Tyne, North East
Danaher Corporation
Posted 13 days ago
Job Viewed
Job Description
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Leica Biosystems, one of Danaher's ( 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
At Leica Biosystems, we're not just shaping the future of cancer diagnostics - we're transforming lives. Our mission of "Advancing Cancer Diagnostics, Improving Lives" is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. When you join Leica Biosystems, you're not just taking a job; you're becoming part of a passionate team that knows every moment matters when it comes to cancer. You'll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of next-generation, life-changing therapies. Surrounded by a diverse and collaborative global community, you'll be inspired each day to stretch, grow, and make an impact.
Learn about the Danaher Business System ( which makes everything possible.
The Principal Specialist, Quality Assurance (Design) for Leica Biosystems is responsible for delivering and sustaining advance staining reagents and diagnostic assays into the Clinical Market.
This position reports to the Director, Quality Assurance & Regulatory Compliance and is part of the Quality Assurance and Regulatory Compliance Department located in Newcastle-upon-Tyne and will be an on-site position.
In this role, you will have the opportunity to:
+ Work on site projects to support the progression of the most viable commercial/strategic opportunities for New Product Development (NPD) or Product Lifecycle Management (PLCM).
+ Provide Design Control leadership across or within function, working with other LBS and Danaher sites.
+ Work independently and with project team members to develop and improve processes to reduce variability and increase robustness throughout the development and product lifecycle for multiple projects.
+ May lead functional teams or projects with moderate resource requirements, risk, and/or complexity
+ Work closely with Regulatory Affairs on deliverables for global regulatory submissions, including FDA 510(k)s and PMAs and IVDR CE certifications.
The essential requirements of the job include:
+ Strong working knowledge of Design Controls & Design/Development practices for regulated products.
+ Extensive experience in IVD medical device new product development and design controls.
+ Extensive knowledge of international IVD medical device quality systems including but not limited to 21 CFR 820, ISO 13485, ISO 14971 & MDSAP.
+ Quality leadership experience with IVD medical devices.
+ Bachelor's degree in science, medical or technical field and experience with increasing responsibility in medical device Quality Assurance
Travel, Motor Vehicle Record & Physical/Environment Requirements:
+ Ability to travel - up to 20% travel
It would be a plus if you also possess previous experience in:
+ Experienced in delivering higher classification medical devices and/or companion diagnostic products to market.
+ Supplier Auditing and/or Quality Assurance.
+ Experience with the MDSAP Programme
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Leica Biosystems, one of Danaher's ( 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
At Leica Biosystems, we're not just shaping the future of cancer diagnostics - we're transforming lives. Our mission of "Advancing Cancer Diagnostics, Improving Lives" is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. When you join Leica Biosystems, you're not just taking a job; you're becoming part of a passionate team that knows every moment matters when it comes to cancer. You'll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of next-generation, life-changing therapies. Surrounded by a diverse and collaborative global community, you'll be inspired each day to stretch, grow, and make an impact.
Learn about the Danaher Business System ( which makes everything possible.
The Principal Specialist, Quality Assurance (Design) for Leica Biosystems is responsible for delivering and sustaining advance staining reagents and diagnostic assays into the Clinical Market.
This position reports to the Director, Quality Assurance & Regulatory Compliance and is part of the Quality Assurance and Regulatory Compliance Department located in Newcastle-upon-Tyne and will be an on-site position.
In this role, you will have the opportunity to:
+ Work on site projects to support the progression of the most viable commercial/strategic opportunities for New Product Development (NPD) or Product Lifecycle Management (PLCM).
+ Provide Design Control leadership across or within function, working with other LBS and Danaher sites.
+ Work independently and with project team members to develop and improve processes to reduce variability and increase robustness throughout the development and product lifecycle for multiple projects.
+ May lead functional teams or projects with moderate resource requirements, risk, and/or complexity
+ Work closely with Regulatory Affairs on deliverables for global regulatory submissions, including FDA 510(k)s and PMAs and IVDR CE certifications.
The essential requirements of the job include:
+ Strong working knowledge of Design Controls & Design/Development practices for regulated products.
+ Extensive experience in IVD medical device new product development and design controls.
+ Extensive knowledge of international IVD medical device quality systems including but not limited to 21 CFR 820, ISO 13485, ISO 14971 & MDSAP.
+ Quality leadership experience with IVD medical devices.
+ Bachelor's degree in science, medical or technical field and experience with increasing responsibility in medical device Quality Assurance
Travel, Motor Vehicle Record & Physical/Environment Requirements:
+ Ability to travel - up to 20% travel
It would be a plus if you also possess previous experience in:
+ Experienced in delivering higher classification medical devices and/or companion diagnostic products to market.
+ Supplier Auditing and/or Quality Assurance.
+ Experience with the MDSAP Programme
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .
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This advertiser has chosen not to accept applicants from your region.
1
Senior Quality Assurance Engineer - Remote
NE1 4DP Newcastle upon Tyne, North East
£55000 Annually
WhatJobs
Posted 4 days ago
Job Viewed
Job Description
Our client, a leading innovator in advanced manufacturing, is seeking a highly skilled and motivated Senior Quality Assurance Engineer to join their globally distributed, remote-first team. This pivotal role is responsible for upholding and enhancing the rigorous quality standards that define our client's product excellence. You will be at the forefront of designing, implementing, and executing comprehensive quality assurance strategies, ensuring that all manufactured goods meet or exceed customer expectations and regulatory requirements. This position requires a deep understanding of manufacturing processes, quality control methodologies, and continuous improvement initiatives.
Responsibilities:
Responsibilities:
- Develop and implement robust quality assurance plans and procedures for manufacturing lines.
- Design, execute, and maintain test cases and test scripts for product validation.
- Conduct root cause analysis of quality deviations and implement corrective and preventive actions (CAPA).
- Collaborate with R&D, engineering, and production teams to ensure quality is integrated throughout the product lifecycle.
- Oversee and participate in internal and external audits to ensure compliance with industry standards (e.g., ISO 9001).
- Analyze quality data and trends to identify areas for improvement and report findings to senior management.
- Lead and mentor junior QA personnel, fostering a culture of quality consciousness.
- Stay current with advancements in manufacturing technology and quality assurance techniques.
- Champion continuous improvement efforts across all manufacturing operations.
- Bachelor's degree in Engineering, Manufacturing, or a related technical field.
- Minimum of 6 years of progressive experience in quality assurance within a manufacturing environment.
- Strong knowledge of quality management systems, statistical process control (SPC), and Six Sigma methodologies.
- Experience with various manufacturing processes and materials.
- Excellent analytical, problem-solving, and critical thinking skills.
- Proficiency in data analysis and reporting tools.
- Exceptional communication and interpersonal skills, with the ability to collaborate effectively across distributed teams.
- Demonstrated leadership capabilities.
- Experience with automated testing tools is a plus.
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2
Senior Pharmaceutical Quality Assurance Manager
Newcastle upon Tyne NE1 4DP Newcastle upon Tyne, North East
£75000 Annually
WhatJobs
Posted 9 days ago
Job Viewed
Job Description
A leading pharmaceutical company in Newcastle upon Tyne, Tyne and Wear, UK is seeking a highly experienced and meticulous Senior Pharmaceutical Quality Assurance Manager to ensure the highest standards of product quality and regulatory compliance. This critical role involves overseeing the Quality Assurance department, developing and implementing robust quality systems, and ensuring adherence to Good Manufacturing Practices (GMP) and other relevant regulations. You will be responsible for conducting internal audits, managing external inspections, and leading the investigation of deviations and non-conformances. The ideal candidate will possess a degree in Pharmacy, Chemistry, or a related life science field, coupled with extensive experience in pharmaceutical Quality Assurance. A deep understanding of regulatory requirements (e.g., FDA, EMA) is essential. Proven experience in managing QA teams, developing quality policies, and implementing quality improvement initiatives is required. Excellent leadership, analytical, and problem-solving skills are paramount. You will be instrumental in fostering a strong quality culture throughout the organisation, ensuring product safety and efficacy. Strong documentation and report-writing skills are necessary. The ability to work effectively under pressure and manage multiple priorities is vital. This is a challenging and rewarding position that offers the opportunity to make a significant contribution to the development and manufacturing of life-saving medicines. If you are a dedicated quality professional with a passion for excellence in the pharmaceutical industry, we encourage you to apply and lead our client's commitment to quality.
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3
Senior Pharmaceutical Quality Assurance Specialist
NE1 4HE Newcastle upon Tyne, North East
£55000 Annually
WhatJobs
Posted 11 days ago
Job Viewed
Job Description
Our client is a prominent pharmaceutical company seeking a highly skilled Senior Pharmaceutical Quality Assurance Specialist to ensure the highest standards of quality and compliance throughout the drug development and manufacturing lifecycle. This critical role is based at their state-of-the-art facility and requires a meticulous approach to quality control and regulatory adherence. You will be responsible for developing, implementing, and maintaining robust quality management systems, conducting audits, and ensuring that all processes meet stringent GxP (Good Practice) guidelines. The ideal candidate possesses extensive experience in pharmaceutical quality assurance, a deep understanding of regulatory requirements, and a commitment to upholding product integrity. This is an on-site position demanding full dedication to the company's operational hub.
Key Responsibilities:
Qualifications:
This is a crucial on-site role based in **Newcastle upon Tyne, Tyne and Wear, UK**, offering a significant opportunity to contribute to the quality and safety of pharmaceutical products for a leading organisation. Our client is committed to excellence and provides a stimulating work environment.
Key Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with GxP regulations.
- Conduct internal and external audits to assess compliance with regulatory requirements, identify potential risks, and recommend corrective actions.
- Review and approve documentation, including SOPs, batch records, validation protocols, and change controls.
- Investigate deviations, out-of-specifications (OOS), and customer complaints, ensuring timely and thorough root cause analysis and implementation of CAPAs.
- Participate in regulatory inspections by health authorities (e.g., MHRA, FDA) and provide support during audits.
- Train personnel on quality assurance principles, GxP requirements, and company procedures.
- Monitor key quality metrics and provide reports to management on the effectiveness of the QMS.
- Collaborate with various departments, including R&D, Manufacturing, and Regulatory Affairs, to ensure quality is integrated into all stages of product development and commercialisation.
- Stay current with evolving regulatory landscapes and industry best practices.
- Manage and maintain quality-related databases and documentation systems.
- Contribute to the continuous improvement of quality processes and procedures.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree is a plus.
- Minimum of 5 years of experience in pharmaceutical quality assurance or a related regulatory compliance role.
- In-depth knowledge of GxP regulations (e.g., GMP, GLP, GCP) and international regulatory guidelines.
- Proven experience in conducting internal and external audits and managing audit responses.
- Strong understanding of pharmaceutical manufacturing processes, quality control, and validation principles.
- Excellent analytical, problem-solving, and critical-thinking skills.
- Exceptional attention to detail and accuracy.
- Strong written and verbal communication skills, with the ability to effectively communicate complex technical and regulatory information.
- Proficiency in using quality management software and standard office applications.
- Ability to work independently and collaboratively in a team-oriented environment.
This is a crucial on-site role based in **Newcastle upon Tyne, Tyne and Wear, UK**, offering a significant opportunity to contribute to the quality and safety of pharmaceutical products for a leading organisation. Our client is committed to excellence and provides a stimulating work environment.
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4
Senior Pharmaceutical Quality Assurance Manager
NE6 5XB Newcastle upon Tyne, North East
£75000 Annually
WhatJobs
Posted 14 days ago
Job Viewed
Job Description
Our client, a renowned global pharmaceutical company, is seeking a highly experienced Senior Pharmaceutical Quality Assurance Manager to lead their quality operations. This is a fully remote, critical role that will ensure adherence to the highest standards of regulatory compliance and quality management across all pharmaceutical activities. You will be responsible for developing, implementing, and maintaining robust quality systems, driving continuous improvement, and fostering a strong quality culture within the organization. This position offers the flexibility of remote work, allowing you to operate from anywhere within the UK while making a significant impact.
Key Responsibilities:
Qualifications:
This is an outstanding opportunity for a seasoned QA professional to take on a leadership role within a respected pharmaceutical organization, working remotely to uphold the highest standards of quality and compliance. Shape the future of pharmaceutical quality with us.
Key Responsibilities:
- Develop, implement, and manage the company's Quality Management System (QMS) in compliance with GMP, ICH, and other relevant regulatory guidelines.
- Oversee and conduct internal and external audits of manufacturing sites, suppliers, and contract manufacturers.
- Manage the CAPA (Corrective and Preventive Actions) system, ensuring effective root cause analysis and implementation of corrective measures.
- Lead regulatory inspection readiness activities and represent the company during regulatory agency inspections (e.g., MHRA, FDA).
- Review and approve critical quality documents, including validation protocols, SOPs, and batch records.
- Manage product quality reviews, deviation investigations, and change control processes.
- Provide expert guidance and training on quality assurance principles and regulatory requirements to cross-functional teams.
- Stay updated on evolving regulatory landscapes and industry best practices, ensuring the QMS remains current and effective.
- Lead quality risk management initiatives and implement risk mitigation strategies.
- Contribute to strategic quality planning and continuous improvement projects.
- Manage a team of QA professionals in a remote setting.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 8-10 years of progressive experience in Pharmaceutical Quality Assurance and Quality Control.
- In-depth knowledge of GMP regulations, ICH guidelines, and international pharmaceutical quality standards.
- Proven experience in managing QMS, conducting audits, and leading regulatory inspections.
- Strong understanding of pharmaceutical manufacturing processes and product lifecycle.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively.
- Demonstrated ability to manage and mentor teams in a remote environment.
- Experience with electronic QMS (eQMS) and LIMS systems is highly desirable.
- Familiarity with the pharmaceutical industry landscape in Newcastle upon Tyne, Tyne and Wear, UK or the wider North East region is a plus, but not mandatory due to the remote nature.
This is an outstanding opportunity for a seasoned QA professional to take on a leadership role within a respected pharmaceutical organization, working remotely to uphold the highest standards of quality and compliance. Shape the future of pharmaceutical quality with us.
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5
Lead Pharmaceutical Quality Assurance Specialist
NE1 3AA Newcastle upon Tyne, North East
£60000 Annually
WhatJobs
Posted 14 days ago
Job Viewed
Job Description
Our client, a prestigious pharmaceutical company, is seeking a highly qualified Lead Pharmaceutical Quality Assurance Specialist to join their team in Newcastle upon Tyne, Tyne and Wear, UK . This hybrid role offers the chance to influence and enhance the quality management systems of critical pharmaceutical products. You will be responsible for ensuring compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other relevant regulatory standards. The Lead Specialist will provide expert guidance, lead quality assurance activities, and contribute to the continuous improvement of quality processes within the organisation.
Key Responsibilities:
Qualifications and Experience:
Key Responsibilities:
- Develop, implement, and maintain robust Quality Management Systems (QMS) in compliance with regulatory requirements (e.g., MHRA, FDA, EMA).
- Lead and execute internal and external audits, including supplier qualification and audits.
- Review and approve batch records, validation protocols, and reports.
- Manage deviations, CAPAs (Corrective and Preventive Actions), and change controls.
- Provide expert QA support to manufacturing, R&D, and other departments.
- Ensure all activities comply with GMP, GDP, and other relevant pharmaceutical guidelines.
- Mentor and train junior QA staff, fostering a strong quality culture.
- Lead quality risk assessments and implement mitigation strategies.
- Stay current with evolving regulatory requirements and industry best practices.
- Contribute to regulatory submissions and inspections.
Qualifications and Experience:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline. A Master's degree is a plus.
- Minimum of 6 years of progressive experience in pharmaceutical Quality Assurance.
- In-depth knowledge of GMP, GDP, ICH guidelines, and regulatory compliance.
- Proven experience in conducting and leading audits.
- Strong understanding of pharmaceutical manufacturing processes and validation.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional written and verbal communication skills, with the ability to present complex information clearly.
- Demonstrated leadership capabilities and the ability to influence cross-functional teams.
- Proficiency in quality management software and Microsoft Office Suite.
- Experience with sterile manufacturing or biologics is advantageous.
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6
Senior Pharmaceutical Quality Assurance Specialist
NE1 4EQ Newcastle upon Tyne, North East
£50000 Annually
WhatJobs
Posted 19 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is seeking a highly skilled Senior Pharmaceutical Quality Assurance Specialist to join their team in **Newcastle upon Tyne, Tyne and Wear, UK**. This critical role will ensure that all manufactured products meet rigorous quality standards and comply with regulatory requirements. You will be instrumental in developing, implementing, and maintaining the quality management system, conducting audits, and driving continuous improvement initiatives within the pharmaceutical manufacturing environment.
Responsibilities:
Qualifications:
Responsibilities:
- Develop, implement, and maintain the Quality Management System (QMS) in accordance with GMP, ICH, and other relevant regulatory guidelines.
- Conduct internal and external audits of manufacturing processes, facilities, and suppliers to ensure compliance.
- Review and approve batch records, validation documents, and change controls.
- Investigate deviations, CAPAs (Corrective and Preventive Actions), and customer complaints, ensuring timely and effective resolution.
- Participate in regulatory inspections and provide necessary documentation and support.
- Develop and deliver quality training programs to relevant personnel.
- Monitor key quality metrics and prepare quality reports for management review.
- Collaborate with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to address quality issues and drive product lifecycle improvements.
- Stay current with evolving pharmaceutical regulations and industry best practices.
- Lead and participate in continuous improvement projects to enhance product quality and process efficiency.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
- Minimum of 5 years of experience in Quality Assurance within the pharmaceutical industry.
- In-depth knowledge of GMP, ICH guidelines, and other relevant regulatory frameworks.
- Experience with conducting audits, managing deviations, and implementing CAPA systems.
- Strong analytical and problem-solving skills, with meticulous attention to detail.
- Excellent written and verbal communication skills, with the ability to effectively communicate complex quality concepts.
- Proficiency in quality management software and standard office applications.
- Ability to work independently and collaboratively within a team environment.
- Experience with (Specific Therapeutic Area or Drug Development Stage) is a plus.
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7
Senior Pharmaceutical Quality Assurance Manager
NE1 1AA Newcastle upon Tyne, North East
£70000 Annually
WhatJobs
Posted 24 days ago
Job Viewed
Job Description
Our client, a highly respected and innovative pharmaceutical company, is seeking a Senior Pharmaceutical Quality Assurance Manager to join their expanding global team. This fully remote position offers a unique opportunity to contribute to the development and delivery of life-saving medicines while enjoying the flexibility of working from home. You will be responsible for overseeing and enhancing the company's Quality Management System (QMS), ensuring compliance with global regulatory standards (FDA, EMA, MHRA, etc.) across all pharmaceutical development and manufacturing activities.
Responsibilities:
Responsibilities:
- Develop, implement, and maintain a robust Quality Management System (QMS) for pharmaceutical research, development, and manufacturing activities.
- Ensure compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP) as applicable.
- Lead and manage quality audits, including internal audits, supplier audits, and regulatory inspections.
- Review and approve critical quality documents, such as batch records, validation protocols and reports, SOPs, and change controls.
- Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing effective CAPAs (Corrective and Preventive Actions).
- Provide quality oversight and guidance to cross-functional teams, including R&D, Manufacturing, Quality Control, and Regulatory Affairs.
- Stay current with evolving global regulatory requirements and industry best practices, advising the business on necessary changes.
- Develop and deliver quality training programs to company personnel.
- Manage and mentor a team of QA professionals, fostering a culture of quality and continuous improvement.
- Participate in product lifecycle management, ensuring quality considerations are integrated at all stages.
- Author and review quality sections of regulatory submissions.
- Master's degree or PhD in Pharmacy, Chemistry, Biology, or a related life science discipline.
- Minimum of 8 years of progressive experience in Quality Assurance within the pharmaceutical or biotechnology industry.
- In-depth knowledge of cGMP, GLP, GCP, and other relevant regulatory guidelines from major health authorities (FDA, EMA, MHRA).
- Proven experience in managing and conducting internal and external audits.
- Strong understanding of pharmaceutical manufacturing processes, quality control, and validation principles.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional written and verbal communication skills, with the ability to communicate effectively with diverse stakeholders.
- Demonstrated leadership capabilities, with experience managing and developing QA teams.
- Proficiency in using QMS software and electronic documentation systems.
- Ability to work independently, manage multiple priorities, and thrive in a remote work environment.
- Experience with biologics or advanced therapy medicinal products (ATMPs) is a significant advantage.
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8
Senior Pharmaceutical Quality Assurance Specialist
NE1 1AA Newcastle upon Tyne, North East
£55000 Annually
WhatJobs
Posted 25 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical innovator, is seeking a meticulous and highly experienced Senior Pharmaceutical Quality Assurance Specialist to ensure compliance with rigorous regulatory standards across their product lifecycle. This fully remote role offers a significant opportunity to contribute to the quality and safety of life-changing medicines from anywhere in the UK. You will be responsible for developing, implementing, and maintaining quality systems, conducting internal audits, and ensuring adherence to Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other relevant guidelines. Your duties will include reviewing batch records, investigating deviations and out-of-specification results, managing change control processes, and preparing for regulatory inspections. You will also play a crucial role in risk assessment and the continuous improvement of quality processes. The ideal candidate will possess a strong understanding of pharmaceutical manufacturing processes, regulatory requirements (e.g., FDA, EMA), and quality management principles. Proven experience in conducting audits, leading investigations, and implementing CAPAs (Corrective and Preventive Actions) is essential. Excellent analytical and problem-solving skills, with a keen eye for detail, are critical. Strong written and verbal communication skills are required for documentation, reporting, and interacting with regulatory bodies and internal stakeholders. A Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field, coupled with a minimum of 7 years of progressive experience in pharmaceutical quality assurance, is required. Experience with Quality Management Systems (QMS) software is highly advantageous. This role is based in **Newcastle upon Tyne, Tyne and Wear, UK**, but is offered as a fully remote position for qualified candidates across the UK. Join a company dedicated to upholding the highest standards of quality and contributing to global health.
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9