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Quality Assurance

Qualified Person

Details

  • Full-time permanent position
  • Office based in Hertfordshire
  • Competitive package
  • Global pharma company

The Role

  • Responsible for the QP certification of Drug Product and Intermediates in accordance with the UK code of Conduct for Qualified Persons, acting as the point of contact for queries relating to QP certification and batch release.
  • Provides an efficient and effective service to support the timely release of  products.
  • Working with site management, ensures that the UK site operates in a fully GMP compliant manner in accordance with all of the relevant legislation, as well as ensuring that the products and processes are fully compliant with the filed regulatory dossiers for the products supported.
  • Working with the Quality Systems Manager ensures that the Quality Management (QMS) is fit for purpose.
  • Engage in the self-inspection of the site QMS.
  • Mentors others to expand on-site compliance knowledge.
  • Supporting senior company leadership through QP decision making to drive continuous improvement and fitness for purpose.
  • Partners proactively with other sites in the supply chain to ensure that products and intermediates are received, released and shipped in a timely and fully GxP compliant manner.
  • Acts as the point of focus for all compliance inspections of the site e.g., internal, customer and regulatory inspections.

Full job description available on application

The Candidate

  • Degree in Pharmacy, Chemistry, Biology or relevant biosciences discipline.
  • Eligible for nomination as a Qualified Person
  • Eligible for nomination as a Responsible Person
  • Supervisory or management experience is desirable
  • Auditing experience is desirable
  • Proven technical ability including: knowledge of GMP/GLP, QMS, test method validation & equipment qualification, Lean and 6 sigma continuous improvement.
  • Excellent interpersonal skills including good communication, conflict management and leadership.
  • Excellent decision making and problem solving skills.
  • Excellent organisation & planning skills.
  • Ability to work in a team and solo capacity.
  • Only candidates with existing right to work in the UK/EU will be considered

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