Senior QP, Staff Associate
- Badhoevedorp, Netherlands
- Department: Quality
- Region: EU+/Canada
We are looking for a Delegated Qualified Person to join our Team in the Netherlands. Once joining you will be able to work closely with the local QP and will be working in a small local and international team.
Act as Delegated Qualified Person (QP) responsible for the certification of Finished Products within the European Union (EU) of medicinal products for human use
holding a Marketing Authorisation (MA) or made for export as per European Directive 2001/83/EC, 2017/1572 as well as well as delegated regulation 2017/1569.
Responsible for batch certification of commercial and clinical finished product for the EU and Rest of the World following respectively Annex 16 and 13 of EU regulation.
The QP is responsible for ensuring that each individual batch has been manufactured in compliance with laws in force in Netherlands, in accordance with the requirements of the marketing authorization (MA) and with Good Manufacturing Practice (GMP).
Support QP delegate activities coordination as back up of the manager.
1. EU QP batch certification as per Annex 16 and 13 as delegate QP
• Perform EU QP certification for products under Biogen responsibility
• Act as delegate QP certifying the finished product - responsible for ensuring that each finished medicinal product batch has been manufactured
in accordance with GMP, the terms of the MIA (Manufacturing Authorization), and the MA (Marketing Authorizations).
• Ensure Quality Assurance related Compliance with all National and International Regulations of the Authorities and internal regulations.
• Focusing on the Management of authorized activities and the accuracy and quality of records.
• Review and approve Product Quality Reviews (PQR/APR)
• Record Certification in a register or equivalent document.
2. Different stages of manufacturing
• Ensure that all necessary steps have been completed under accepted pharmaceutical quality systems to assure compliance of the batch with
GMP, the MA and any other legal obligations in the Member State where certification is taking place.
• Participate in Quality Management Reviews of applicable Manufacturing sites and Global Supply Chain Management Review as back up.
• Where applicable provide requirements for Manufacturing sites to be reflected in respective Quality Agreements
• Contribute to suppliers and customers approval in coordination with responsible departments.
3. Manufacturing license maintenance
• CoHost GMP Health Authority Inspections; responsible for readiness, preparation and coordination. Lead related follow-up and commitments implementation.
• Co-Host internal Audits and coordinate and lead related follow up and CAPA implementation.
• Support Product Complaints related investigation as necessary.
• Contribute with all necessary departments to ensure that communication to the Authorities is appropriate, coordinated and approved.
5. Marketing Authorization filing currency and support
• Partner with Regulatory team while liaising with operations, technical operations, science & technology teams in relation to product filing.
• Assure continuous currency with applicable filings
6. Coordinate the Delegate QP team activities and act as back up of the Manager. Foster improvement culture.
MSc in Industrial Pharmaceutical Science or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC
• Third level qualification in a science discipline with minimum 7 years’ experience in the healthcare/pharmaceutical industry gained in a FDA and EMA approved pharmaceutical environment. Experience as a QP from biotech or pharmaceutical industry.
• Thorough understanding of pharmaceutical law, quality management systems and the professional duties of a QP
• Mathematical and statistical skills
• Medicinal chemistry and technical pharmaceutical knowledge
• Strong understanding of the manufacture and supply chain
• Leadership skills
• Ability to cope well under pressure, make confident judgements and act decisively when things go wrong