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Quality Assurance Officer

Cambridgeshire   •  Negotiable  •  Contract/Temporary, Full time


Quality Assurance Officer - Cambridge

12 Month contract

22.58 per hour

Cpl Life Sciences are recruiting for an experienced Quality Assurance Officer to join a global pharmaceutical company on a 12 month contract basis.

The companys focus is to improve the lives of patients globally and are looking for someone who wants to contribute in the success of this. This is a hands on position and a key part of the business, if you are an experienced Quality Officer looking for a position that makes a difference then this is the role for you.

This position will be handling the validation process and reviewing documentation to validate it, this is a role within a GMP environment so experience is preferred.

Key Responsibilities;

  • Taking responsibility for Quality and GMP compliance
  • QA release of internal drug substance, drug product and investigational medicinal product for clinical trials
  • Ensuring activities and processes across the development chain meet regulatory standards
  • Provide Dev Q input into internal manufacturing activities for Drug Substance, Drug Product and Pack & Label including approval of manufacturing documentation
  • Responsible for developing and approving GMP documentation and QA risk assessments and suggest mitigation activities and technical approaches to manufacturing for Drug Substance and Drug Product
  • Responsible for DevQ release of internal manufactured Drug Substance, Drug Product and Investigational Medicinal Product for clinical trials
  • Provide advice to support the development, implementation and continuous improvement of GMP quality systems across the functions and support implementation of agreed global standards
  • Responsible for QA approval of documentation related to manufacturing equipment and facilities to ensure GMP compliance, including maintenance, calibration, validation and change control
  • Drives, role models and supports a strong lean culture that promotes standardisation, simplification and continuous improvement

Experience;

  • Scientific degree
  • 3-5 years working within pharmaceutical GMP
  • Understanding of quality systems and GMP
  • Understanding of pharmaceutical and drug development
  • Scientific understanding of products
  • Quality experience

For more information please contact amy.goddard@cpl.com

  • Agency: Cpl Life Sciences
  • Contact: Amy Goddard
  • Reference: JO-2111-479655
  • Posted: 5th November 2021
  • Expires: 3rd December 2021

Cpl Life Sciences

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