Act as Qualified Person (QP) responsible for the certification of Finished Goods within the European Union (EU) of medicinal products for human use holding a Marketing Authorization (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.

Major responsibilities:

EU QP batch certification as per Annex 16 and 13

•        Perform EU QP certification for all products under Biogen responsibility including partners products

•        The QP certifying the finished product is 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)

•        Certification is recorded in a register or equivalent document.

•        Ensure that at minimum one deputy QP is in place to perform EU QP Certification; ensure the deputy QP has the necessary experience and education required.
Ensure maintenance of supply to the market

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.

•        Where applicable provide requirements for Manufacturing sites to be reflected in respective Quality Agreements

•        Ensure that suppliers and customers are approved in coordination with responsible departments. Approve any subcontracted activities, which may impact on GMP.

Manufacturing license maintenance

•        Assure QMS for Manufacturing License is appropriate and maintained.

•        Host GMP Health Authority Inspections; responsible for readiness, preparation and coordination. Lead related follow-up and commitments implementation.

•        Host  internal Audits and coordinate and lead related follow up and CAPA implementation.

•        Lead and coordinate Self-Inspection program including risk management.

•        Responsible for GMP Service Providers qualification and monitoring.

Complaints and recalls

•        Support Product Complaints related investigation as necessary.

•        Authorize recall in collaboration with Recall Committee.

•                Cooperate with all necessary departments to ensure that communication to the Authorities is appropriate, coordinated and approved.

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 Manage the Delegate QP team

Ensure Training of the team and development of the team member. Adapt team organization to ensure supply to the market and adequat communication with stakeholder. Foster Continuous Improvement culture.

Education:

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

Experiences:

Third level qualification in a science discipline with minimum 8 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. Proven knowledge of AMG 2017