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Head of Quality Assurance

2 months ago

Hertfordshire, United Kingdom X4 Life Sciences Full time
Job Description

Exciting opportunity: Head of Quality for a growing generics pharmaceutical manufacturer.


If you are a seasoned Quality professional, based in or around Hertfordshire, with leadership experience in the pharmaceutical industry, this role might be for you


Your Responsibilities:

  • Responsible to oversee and continually review the quality management system to ensure that improvements are identified and that any deficiencies are addressed at their root cause and appropriate procedures are developed and fully implemented.
  • Verify and ensure that the products are manufactured, packed and tested to the requirements of registered MA.
  • Responsible to review the third-party audit reports for APIs and packaging materials. Responsible for the review of annual product quality reviews.
  • Ensuring complaints and adverse incidents are accurately recorded and addressed in a thorough and timely manner in accordance with the company QMS.
  • Responsible for hosting MHRA inspections, writing the response reports and to liaise with the Medicines Inspectorate to ensure that the Company conforms to the requirements of GMP and the Manufacturing and Product Licenses.
  • Develop, manage and maintain the company's device family technical files and product specific design dossiers ensuring compliance with the relevant regulations.
  • Remain up to date with impending changes and developments regarding regulatory and compliance requirements as well as evolving best practices in compliance control.
  • To approve specifications, sampling instructions, test methods, and QC procedures, including amendments.
  • To approve and monitor suppliers of raw materials and packaging components.


Your experince, skills and qualifications:

  • A bachelors or associate degree.
  • A minimum of 5 years experince in the Quality Assurance at a manufacturing site
  • Previous experince in a leadership role.
  • Extensive Pharmaceutical Industry experince with hands on experince in development/quality in a GxP environment.


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