Quality Assurance Officer- Batch Release

4 weeks ago

Marlow, United Kingdom SRG Full time

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
  • 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.

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