Analytical Science & Technology (AS&T) Senior Validation Specialist
Job Details
Full Job Description
Responsibilities :
Development/Improvement
activities:
Serve as SME to support Site/Global
projects.
Proactively identifies scope for improvement or
development based on knowledge of short to mid-term business
needs.
Leads and develops a strategy, plans and manages projects
for method development or improvement as identified.
Makes data
supported decisions on project progression; uses technical expertise
to overcome analytical issues.
Documents project work as detailed
lab book records or under technical protocols and reports as
appropriate.
Disseminates project findings/status updates at
regular meetings/forums within Global AS&T.
Represents as an
interface between AS&T and key stakeholders (QC, MS&T, Regulatory
Affairs).
Operations Support:
Participates
in lab work-load planning with the wider team.
Design work
plans/projects with a compliance development mindset i.e., GMP
adherence.
Performs tests in accordance with established methods
and properly documents test results.
Provides
guidance/mentorship/training to other lab staff as
required.
Evaluates performance of analytical instruments and
equipment and recommends new acquisition or replacements
initiatives.
Authors/Reviewer protocols and reports for
suitability studies and investigations to support testing and
compliance issues, technical writing proficient.
Ensures
laboratory instruments are qualified, calibrated and properly
maintained and documentation complies with cGMP standards.
Assists
and maintains standard operating procedures (SOPs), risk assessments
and other quality documentation as required.
Documents quality
issues and performance measures for management review.
Qualifications :
Bachelor’s degree in a relevant scientific discipline (Chemistry, Biochemistry.)
MSc (desirable )
PhD (desirable )
A recognized expert in Analytical and
Biological methods (CE, ELISA, SDS-PAGE)
Experience of working in
pharmaceuticals, particularly biologics is advantageous.
Experience of assay development and validation essential.
Assay lifecycle from proof of concept to registration and change
management.
Desirable to have experience of process or product
characterization using a variety orthogonal method.
Desirable to have people leader experience and or leading project teams.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
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About CSL Seqirus CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus .
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Analytical Science & Technology (AS&T) Senior Validation Specialist
Seqirus Vaccines Limited
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