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Quality Assurance Manager

SRG
  • GB
    Manchester, England, United Kingdom
  • GB
    Manchester, England, United Kingdom

Über

QA Manager Greater Manchester SRG is currently working exclusively with a highly successful & award winning, CDMO based in Greater Manchester. Growing rapidly, the business specialises in taking products from discovery, all the way through early-stage trials, and to approval. They are now looking for a QA Manager to lead a small team and oversee quality, safety and efficacy standards at their new GMP facility.
The role : In this role, you will lead and manage the Quality Assurance team at a GMP Manufacturing site in Greater Manchester. Key responsibilities will include :
Leading the QA team and supporting other departments to maintain a culture of quality.
Manage the QMS and processes, ensuring full compliance with GMP, regulatory & customer expectations.
Support batch release activities by the QP.
Lead the Investigations of deviations, complaints and OOS to prevent future non-conformance, implementing effective CAPAs.
Lead internal audits and support site audit readiness.
Support external / regulatory inspections.
Approval and management of outside suppliers.
Support ongoing training and continuous improvement activities.
Requirements :
A degree or equivalent qualification in a relevant scientific field.
Proven experience in a supervisory or leadership Quality assurance position in a GMP environment.
Previous experience in analytical or GMP production environments.
Experience of Early-stage produce development, or IMPs would be advantageous.
Excellent knowledge of GMP requirements & compliance
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  • Manchester, England, United Kingdom

Sprachkenntnisse

  • English
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