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Quality Assurance Officer- Batch Release
4 months ago
SRG are working with a Global Consumer Pharmaceutical company to help them find a
Quality Assurance Officer
to join their busy team.
Reporting to a Quality Batch Release Manager, provide day-to-day assistance for commercial QA activities associated with remote/virtual batch disposition. The QA officer will ensure assigned tasks are performed in a timely manner to meet batch disposition, supply chain and all associated international GMP/GDP requirements.
Key Responsibilities will include:
To compile & review batch document sets for completeness & compliance to EU GMP, Pfizer internal requirements and regulatory dossier submissions.nTo resolve manufacturing, testing, packaging, and supply chain issues to support batch disposition.nTo complete all relevant documentation to support the QP in the release of drug products To assist the certifying QP in the release of the drug product where required within Pfizer systems.nTo assist in maintenance of quality systemsincluding complaint handling,deviations/exception reporting, change control, supply agreements, document control, complaint handling, quality metrics reporting, temperature excursion resolution, document control and retention systems, training as determined by the Quality Manager.nProject execution and supportas required.
Candidate Requirements:
Bachelor’s degree in a related scientific discipline with relevant experience (Preferably Biology/ Chemistry/ Pharmacy/ Life Sciences)n2-3 years in a GMP environmentnBasic experience in pharmaceutical manufacturing, distribution, and control measuresnBasic experience in Quality administered systems. Previous use of TrackWise® QMS beneficial.nExperience in operating in a QMS.nExperience in writing deviations, change controls, CAPAs, complaints.nExperience in supporting internal and external audits including BOH inspections.nKnowledge of API manufacture, primary compounding, primary and secondary packaging and release, preferred.nAbility to apply technical knowledge and understanding to making appropriate and timely risk-based decisions.nAble to demonstrate good planning and organisation skills.nAttention to detail and accuracy – able to follow verbal and written instruction (SOP’s).