Quality Assurance Manager - England

Regulatory and Quality - Quality Assurance/ HSE
Ref: 1098 Date Posted: Tuesday 11 Dec 2018
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Quality Assurance Manager (GMP) - Staffordshire

Entrust People are currently supporting one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets.

Reporting to the Associate Director of QA, this role will assist with company compliance to cGMPs, global, and local requirements as it relates to the importation, storage, packaging, certification and disposition of Clinical Trial materials. 

You will ideally come from a Pharmaceutical background within QA and must have experience working within a GMP environment.

Key Responsibilities

  • Execution and maintenance of existing Quality systems.
  • Review, approval and issuance of SOPS.
  • Review, approval and issuance of batch documentation.
  • Control, maintenance and archiving of superseded GMP documentation.
  • Implementation, routine review and approval of process change controls.
  • Involvement with investigations arising from deviations.
  • Assist with both internal and external audits and follow up of subsequent actions.
  • Support the implementation of the vendor approval system.
  • Assist in other QA functions and responsibilities such as Material Retains, Document Control filing and retrieving of documents and general support of the Quality Organization
  • Communicate and interact with all departments, to include direct management
  • Verify specified documents for accuracy
  • Assist in the continuous improvement of the organization’s quality and quality processes
  • Cross-train within the Quality Organization, where applicable

About you

To be successful in your application for this role you will be required to have the following background/experience:

  • Minimum 5 years of QA experience within a GMP environment.
  • Experience with document review and control.
  • Able to execute independently, making sound decisions to maintain Quality and Compliance
  • Good written and verbal communication skills

Desirable

  • Audit experience, FDA/MHRA
  • A degree or equivalent in Chemistry, Pharmacy or Biology.

If you would like to discuss the above opportunity in more detail or discuss any other potential opportunities, please contact one of our experienced consultants Suzi Robertson on +44(0)1224 608988 or email suzi@entrustpeople.co.uk with a CV and she will be delighted to talk about the next step of your career.