Qualified Person

Qualified Person - Europe - Relocation required

** The location is confidential and can be disclosed during the initial conversation **

We're supporting a global biopharmaceutical organisation which has a focus on biosimilars and monoclonal antibodies. They are looking to bring in a Qualified Person (QP) with expertise in Sterile/Biological products to join our 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:

• 5+ years pharma/biopharma experience, 2+ years as QP.
• Eligible European QP for 2001/83/EC, 2003/94/EC, Annex 16.
• Strong EU GMP/GDP knowledge.

Join us to lead in Sterile/Biological QP roles, impacting product quality within strict regulatory frameworks.

The position is remote and you will be required to travel to the facility once a month for a period of a week.

Please apply to have a confidential discussion regarding the opportunity.