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.