Agrimin Ltd – Arlanda Way, Humberside Airport, Kirmington DN39 6YH
Closes in 4 days (10 Jul)
The Quality Manager at Agrimin is a permanent, full time position to oversee compliance of GMP, primarily but also FAMI-QS and HACCP quality systems.
The Quality Manager will report to the Technical Manager on a day-to-day basis and as part of the technical team will be responsible for the maintenance and ongoing improvement of the quality management system. Responsibilities include but are not limited to:
- Compliance with EU GMP and FAMI-QS.
- Preparation of quality documentation including, product quality reviews, quality risk management, stability study protocols, equipment and process qualification and validation.
- Performing and the supervision of audits – both internal and external.
- Documentation and investigation of Out of Specifications (OOSs) and deviations.
- Technical dossier authoring, with particular focus on CMC sections, including; stability trend analysis, analytical testing and validation, and justification of specifications.
- Support the Technical Director on Pharmacovigilance, PSUR’s and adverse event reporting
- GMP training of Agrimin staff.
- Review of batch documentation.
- Data integrity.
- Maintenance, review and documentation of company standard operating procedures.
- Management of the QA officer.
Job Context/Key Challenges:
The Quality Manager is expected to work closely with other members of the team, in particular the laboratory team, the Regulatory, QC and R&D Administrator and the Production Manager.
Knowledge and Experience:
The ideal candidate would be educated to degree level in a relevant scientific discipline, have an analytical mind, good computer skills and the ability work within small cross-functional teams. Experience of FAMI-QS, HACCP and risk assessment would be a distinct advantage.
To apply please send a CV and Covering Letter to email@example.com