Quality Manager

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Agrimin Ltd – Arlanda Way, Humberside Airport, Kirmington DN39 6YH
Closes in 4 days (10 Jul)


Job Purpose:

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.

 

Principle Accountability:

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 charvey@agrimin.co.uk

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