Qualified Person (QP) – GMP Release Lead, On-site

Prothya Biosolutions; Amsterdam; Vor Ort; EUR 73.000 - 105.000; Vollzeit

Benefits dieser Stelle

Flexible working hours

Holiday pay 8.33%

Thirteenth month

30 holidays

Training budget

Travel cost reimbursement

Pension plan

On-site parking

Zusammenfassung

Prothya Biosolutions is seeking a Qualified Person (QP) to certify finished products and oversee compliance with GMP, MIA, and MA requirements. The role includes release of blood plasma and intermediates per Annex 14 and close collaboration with departments to ensure regulatory communications are accurate and approved.

The ideal candidate holds a Pharmacist or MSc in Pharmaceutical Sciences, with at least 5 years in healthcare/pharma, and prior QP experience in biotech or pharma manufacturing.

Qualifikationen

• Pharmacist or MSc in pharma-related field with regulatory eligibility for QP status.
• At least 5 years’ experience in healthcare/pharma (production or QC labs).
• Experience as a QP in biotech or pharmaceutical manufacturing.
• Fluent English and Dutch (conversational).
• Ability to work on-site.

Aufgaben

• Perform EU QP certification for all products under Prothya Biosolutions B.V. responsibility including products of contract partners.
• Ensure Quality Compliance with all National and International Regulations and internal company regulations.
• Oversee QMS, including Quality Management Reviews, Quality Agreements, Product Quality Reviews.
• Maintain the Manufacturing License.
• Approve Product Quality Complaints related investigations.
• Cooperate with all necessary departments to ensure proper communication to Authorities.

Kenntnisse

Persuasiveness

Decisiveness

Fluent English

Dutch (conversational)

Ausbildung

Pharmacist/MSc in Pharmaceutical Sciences

Jobbeschreibung

Prothya Biosolutions is seeking a Qualified Person (QP) to certify finished products and oversee compliance with GMP, MIA, and MA requirements. The role includes release of blood plasma and intermediates per Annex 14 and close collaboration with departments to ensure regulatory communications are accurate and approved.

The ideal candidate holds a Pharmacist or MSc in Pharmaceutical Sciences, with at least 5 years in healthcare/pharma, and prior QP experience in biotech or pharma manufacturing.