Eu Qualified Person for Investigational and
Vor 3 Tagen
General Description:
The incumbent will report to the Head EU QP Team.
The Qualified Person IMP certifying all manufacturing steps up to 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 and Import Authorization) and the IMPD as per European Directive 2001/83/EC.
Responsible for batch certification of IMP for the EU and Rest of the World following Annex 13 and Clinical Trial Regulation (CTR, 536/2014) of EU regulation respectively.
The Qualified Person Commercial Products certifying all manufacturing steps up to 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 and Import Authorization), the MA (Marketing Authorization) or made for export as per European Directive 2001/83/EC.
Responsible for batch certification of commercial finished product for the EU and Rest of the World following Annex 16 of EU regulation respectively.
Ideally also qualifies as a Responsible Person GDP taking accountabilities according EU GDP 2013/C 343/01.
Location: ideally in Lörrach (Germany) or Basel (Switzerland) and the surrounding area
Essential Functions of the job:
Major responsibilities:
- Perform EU QP certification for IMPs and commercial products under BeiGene responsibility.
- Ensure Quality Compliance with all National and International Regulations of the Authorities and internal company regulations.
- Oversight of Quality Management System (QMS) which includes Quality Management Review, Quality Agreements.
- Maintain QMS oversight as part of QP operational responsibilities (EU GMP Annex13, CTR and Annex 16).
- Maintenance of the Manufacturing and Import Authorizations.
- Providing guidance and integration of European and other Health Authority regulations.
- Ensuring GMP knowledge of self and others within both the Quality team and other functions are kept up to date.
- Participate as required in self-inspection activities and external audits.
- Lead and coordinate Self-Inspection program including risk management.
- Host and support regulatory inspections, audits by clients / partners.
- Input on quality policy, objectives and deliverables for business.
- Focusing on the management of authorized activities and the accuracy and quality of records.
- Ensure maintenance of clinical trial supplies.
- Ensure that all necessary steps have been completed according to the Quality Management System to assure compliance of the batch with GMP, the IMPD 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.
- Host GMP Health Authority Inspections; responsible for readiness, preparation and coordination.
- Host internal Audits and coordinate follow up.
- Responsible for GMP Service Providers qualification and monitoring.
- 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.
Supervisory Responsibilities:
- May manage staff, coach, and support development of employees in the future
- Ensure training of the team and development of the team member. Adapt team organization to ensure supply to the market and adequate communication with stakeholders. Foster continuous improvement culture.
Education Required:
- Pharmacist/MSc or Scientist recognized by Regulatory Authority to permit Qualified Person (QP) status as per article 49 of Directive 2001/83/EC.
- A minimum of 10 years of experience in the healthcare/pharmaceutical industry gained in an EMA and FDA approved pharmaceutical environment. Experience as a EU QP in pharmaceutical or biotech industry.
- Solid foundation in clinical trials, QA and understanding of quality requirements through the clinical supply chain and commercial value chain.
Competencies:
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
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