Qualified Person (QP)

Prothya Biosolutions; Amsterdam; In loco; EUR 73.000 - 105.000; Tempo pieno

Vantaggi offerti da questo lavoro

Flexible working hours

Holiday pay 8.33%

Thirteenth month

30 holidays

Training budget

Travel cost reimbursement

Pension plan

On-site parking

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Persuasiveness

Decisiveness

Fluent English

Dutch (conversational)

Formazione

Pharmacist/MSc in Pharmaceutical Sciences

Descrizione del lavoro

As our Qualified Person (QP)/ Responsible Person (RP) you are certifying the finished product and are responsible for ensuring that each finished medicinal product batch has been manufactured in accordance with GMP, the terms of the MIA (Manufacturing and Import Authorization), and the MA (Marketing Authorizations). Also included is the responsibility of the release of blood plasma and all further intermediates according to Annex 14.

• 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
• Oversight of QMS (Quality Management Reviews), which includes Quality Management Reviews, Quality Agreements, Product Quality Reviews
• Maintenance of the Manufacturing License
• Approve Product Quality Complaints related investigations
• Cooperate with all necessary departments to ensure that communication to the Authorities is appropriate, coordinated and approved

Your profile

• Pharmacist/ MSc in Pharmaceutical Sciences or one of the following scientific disciplines: Biopharmaceutical Sciences, Medicine, (Bio-)Chemistry or Biotechnology or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC
• A minimum of 5 years of experience in the healthcare/pharmaceutical industry (Production, QC-labs)
• Experience as a QP in the biotech or pharmaceutical manufacturing industry
• Persuasiveness and decisiveness
• Shows sense of urgency and sensitive for the needs of the organization
• Fluent in English and conversational level of Dutch
• Ability to work on-site

Our offer

• Employment for 36h or 40h with flexible working hours in consultation.
• Salary between € € 6.573,20 and € 9.448,98 euro gross per month based on full-time employment.
• 8.33% holiday allowance and a 13th month payment.
• 30 holiday days (based on fte).
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.
• A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.