A growing pharmaceutical manufacturer requires a QA Officer to join its team. Having recently cleared their MHRA audit, our client is at a very exciting stage of growth. You will support a busy QA department
in the efficient functioning and implementation of all Quality plans at site. You will have previous QA experience gained within another pharmaceutical manufacturing company.
*To support Quality Assurance in efficient functioning and implementation of all Quality plans at site.
*Operational execution of key elements of the Quality System, including document control, quality training, change control, Deviations, CAPA and Customer complaints, to maintain compliance with GMP standards.
*Writing, reviewing, distributing and filing/archiving of completed Quality System documents.
*Investigating Deviations, Change Control, self-inspections, CAPA processes and batch recall.
*Supporting batch documentation (BMR/BPR/GPS) for product release.
*Sampling of Materials
*Supplier assessment and approval.
Essential skills and experience:
*Graduate, or equivalent, with experience of cGMP and working within a Quality management system environments.
*Two years + experience within QA in the Pharmaceutical industry.
*Demonstrate knowledge and understanding of current regulatory requirements for manufacture licensed medicinal products. Good understating of GMP and GDP and relevant guidelines/updates.
*Knowledge of EU and UK quality related pharmaceutical regulations.
*Experience with Document Control, Deviations, Change Control and CAPA processes.
*Good interpersonal skills and ability to work well within the organisation.
*Experienced in maintaining quality systems, review data, and monitor data trends.
- CAPA - Change Control - Deviation - BMR - BPR - GMP
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