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QP - Biologics
- Posted 03 December 2024
- Job type Permanent
- Reference198045
- Contact NameDuncan Johnston
Job description
Qualified Person - Europe - Relocation required
** The location is confidential and will require relocation. It can be disclosed during the initial conversation **
We're supporting a global biopharmaceutical organisation. They are looking to bring in a Qualified Person (QP) with expertise in Sterile/Biological products to join the QA Team. As a QP, you'll certify Drug Substance, Drug Product, and Finished Combination Products, ensuring compliance and quality.
Responsibilities:
- Act as QP, certifying Sterile/Biological products.
- Provide QP input for investigations (complaints, deviations, OOS) and related CAPAs.
- Review and approve SOPs, reports, and documentation.
- Assess risks, contribute to decisions, handle escalations.
- Support audits/inspections, stay current on global regulations.
Requirements:
- Eligible European QP for 2001/83/EC, 2003/94/EC, Annex 16.
- Strong EU GMP/GDP knowledge.
Please apply to have a confidential discussion regarding the opportunity.