QA Operations Specialist

Highly Competitive
  1. Permanent
  2. Good Manufacturing Practice (GMP)
  3. Iceland
Reykjavík, Iceland
Posting date: 06 Nov 2023
57410

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Proclinical are recruiting for a QA Operations Specialist to join a pharmaceutical organisation. This role is on a permanent basis and is located in Europe.

Responsibilities:

  • QA evaluate and approve product specifications, master batch record, SOPs, study protocols and reports and any other quality documents.
  • Partake in the preparation of inspections as per outlined and agreed role.
  • Serve as a QA shop floor contact with drug product manufacturing, drug substance manufacturing, as an area of accountability.
  • You will document problems and assist the DSM, DPM and QC divisions when required.
  • Assist with and approve change control records and the change action closures.
  • Offer QA knowledge throughout the investigations of deviation and risk assessments, as well as of QA approval and their linked CAPAs approvals.
  • Mentor new personnel of the QA operations team and any other staff when required.
  • Other duties may be assigned to this role.

Key Skills and Requirements:

  • Educated to a degree level with demonstrable experience in a pertinent role, ideally within a pharmaceutical, biotechnology, or medical devices organisation.
  • Currently hold European Citizenship.

If you are having difficulty in applying or if you have any questions, please contact Ayesha Kippie at +41 615 687 995

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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