Quality Assurance Officer- Batch Release
| Dyddiad hysbysebu: | 05 Ebrill 2024 |
|---|---|
| Cyflog: | £15.63 i £16.63 yr awr |
| Oriau: | Llawn Amser |
| Dyddiad cau: | 12 Ebrill 2024 |
| Lleoliad: | Marlow, Buckinghamshire, SL6 6RJ |
| Cwmni: | SRG |
| Math o swydd: | Dros dro |
| Cyfeirnod swydd: | BBBH142631_1712321584 |
Crynodeb
Quality Assurance Officer- Batch Release - Global Pharmaceutical Company
Contract: 23 Month Contract
Location: Hurley, 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
- 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
- To assist in maintenance of quality systems including 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 support as
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).
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.