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Quality Assurance Officer- Batch Release
4 months ago
Quality Assurance Officer- Batch Release – Global Pharmaceutical Company
Contract: 12-Month Contract
Location: Marlow, UK
Salary: £32,000 p/a
Working Pattern: Hybrid
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.
- To resolve manufacturing, testing, packaging, and supply chain issues to support batch disposition.
- To 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.
- To 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.
- Project execution and supportas required.
Candidate Requirements:
- Bachelor’s degree in a related scientific discipline with relevant experience (Preferably Biology/ Chemistry/ Pharmacy/ Life Sciences)
- 2-3 years in a GMP environment
- Basic experience in pharmaceutical manufacturing, distribution, and control measures
- Basic experience in Quality administered systems. Previous use of TrackWise® QMS beneficial.
- Experience in operating in a QMS.
- Experience in writing deviations, change controls, CAPAs, complaints.
- Experience in supporting internal and external audits including BOH inspections.
- Knowledge of API manufacture, primary compounding, primary and secondary packaging and release, preferred.
- Ability to apply technical knowledge and understanding to making appropriate and timely risk-based decisions.
- Able to demonstrate good planning and organisation skills.
- Attention to detail and accuracy – able to follow verbal and written instruction (SOP’s).
