Eu Qualified Person Commercial Products

vor 2 Wochen

Basel, Schweiz BeiGene Vollzeit

General Description:
The incumbent will report to the Head EU QP Team.

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.

Essential Functions of the job:
Major responsibilities:

- Perform EU QP certification for 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 Annex16).
- 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.
- 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 supply to the market.
- Perform GDP activities as required.
- Ensure that all necessary steps have been completed according to the Quality Management System 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.
- Host GMP Health Authority Inspections; responsible for readiness, preparation and coordination.
- Host internal Audits and coordinate follow up.
- Lead and coordinate Self-Inspection program including risk management.
- 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 QP in pharmaceutical or biotech industry.

Solid foundation in QA and understanding of quality requirements through the whole 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.

Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.

Adaptability - Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.

Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to contin

  • Eu Qualified Person Commercial Products

    vor 7 Monaten

    Basel, Schweiz BeiGene Vollzeit

    General Description: The incumbent will report to the Head EU QP Team. 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...

  • Eu Qualified Person Investigational Medicinal

    vor 7 Monaten

    Basel, Schweiz BeiGene Vollzeit

    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...

  • Eu Qualified Person Investigational Medicinal

    vor 2 Wochen

    Basel, Schweiz BeiGene Vollzeit

    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...

  • Mitarbeiterin Qualified Person, Regulatory Affairs

    vor 7 Monaten

    Basel, Schweiz Air Liquide Vollzeit

    **Wer sind wir? **CARBAGAS AG **, ein Unternehmen der Air Liquide Gruppe, produziert und liefert qualitativ hochwertige Gase und anspruchsvolle Gaseanwendungen für den industriellen und medizinischen Einsatz. Wir sind überall in Ihrem Alltag und Sie sehen es nicht! Von den Blasen in Ihrer Limonade über den Chip in Ihrem Smartphone bis hin zur Reduzierung...

  • Fachtechnisch Verantwortliche Person

    Vor 4 Tagen

    Basel, Schweiz BakerHicks Vollzeit

    **BakerHicks **konzentriert sich auf die Planung und Realisierung von biotechnologischen, pharmazeutischen und chemischen Projekten. Dank unserer integralen Dienstleistungspalette und einer zukunftsfähigen Firmenkultur hat BakerHicks in der DACH-Region eine führende Marktstellung erreicht. Um unser Team zu verstärken suchen wir eine motivierte und...

  • Head Drug Product Development EU

    Vor 2 Tagen

    Basel, Schweiz F. Hoffmann-La Roche AG Vollzeit

    Head Drug Product Development EU page is loadedHead Drug Product Development EUApply locations Basel time type Full time posted on Posted 3 Days Ago job requisition id 202411-128745Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to...

  • Director, Commercial Affiliate QA Gmp Gdp and

    vor 7 Monaten

    Basel, Schweiz Idorsia Pharmaceuticals Ltd. Vollzeit

    **About Idorsia Pharmaceuticals Ltd** Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we want to develop Idorsia into one of Europe’s leading biopharmaceutical companies, with a strong scientific core. Headquartered in Switzerland - a European biotech hub -...

  • Eu Regulatory Strategy Lead Hemophilia

    vor 2 Wochen

    Basel, Schweiz Sobi Vollzeit

    **Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.** **EU Regulatory Strategy...

  • Director, Quality Assurance

    vor 2 Wochen

    Basel, Schweiz Moderna Therapeutics Vollzeit

    **The Role**: Reporting to the Head Quality, International Organization, the Director of Quality Assurance Disposition will be responsible for providing QA oversight and support of Moderna’s international organization’s product disposition for clinical and commercial product manufactured at contract manufacturing organizations (CMO) and tested at...

  • Head Drug Product Development EU

    Vor 2 Tagen

    Basel, Schweiz F. Hoffmann-La Roche Gruppe Vollzeit

    Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...

  • Head Drug Product Development EU

    vor 10 Stunden

    Basel, Schweiz Roche Vollzeit

    Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...

  • Quality Manager, Commercial Quality Europe

    vor 7 Monaten

    Basel, Schweiz BeiGene Vollzeit

    General Description: The incumbent will report to the Head Commercial Quality Europe and will be responsible for supporting activities relating to BeiGene’s external GMP operations in Europe and as well as internal BeiGene GMP processes, ensuring procedures and systems are in place to support BeiGene’s commercial products. The incumbent will support...

  • Sr. Director, Marketing Eu

    vor 1 Woche

    Basel, Schweiz Moderna Therapeutics Vollzeit

    **The Role**: Reporting to the VP, Head of EMEA Region, and located in our Basel, Switzerland office, the Senior Director, Marketing EU Region & CH will take responsibility and ownership for aligning and executing the marketing strategy for Moderna’s vaccines (Covid, Flu & RSV) across the geography. Spikevax continues to be a truly groundbreaking product....

  • Commercial Strategy, Product Management Leader

    vor 1 Monat

    Basel, Schweiz Cytiva Vollzeit

    In this capacity, the commercial and strategy leader will be responsible to drive and process manage Filtration Business Unit (BU) commercial strategy, plan development and ensuring that the strategic vision of the filtration product management group is incorporated into Bioprocess sales strategy and programs, and that critical initiatives are executed to...

  • Manager, Customer Care Eu

    vor 7 Monaten

    Basel, Schweiz 1WorldSync Vollzeit

    Are you a highly successful customer care professional with a passion for excellence? Do you have experience leading and transforming a customer care team within a SaaS company? Good news! 1WorldSync is looking for a **Customer Care Manager, EU** to join our team managing from our Portugal, Germany or Swiss office. 1WorldSync is the industry leader in...

  • Lawyer, Investment Products

    Vor 2 Tagen

    Basel, Schweiz ThomasLloyd Global Asset Management Vollzeit

    **Who We Are** ThomasLloyd is a leading independent impact investment solutions provider, advisor and asset manager in sustainable energy infrastructure. We are also one of the most successful investors in sustainable energy infrastructure in high growth and emerging markets in Asia. We have introduced our proprietary market differentiating ThomasLloyd...

  • Executive Director of Quality Assurance

    Vor 5 Tagen

    Basel, Schweiz Proclinical Vollzeit

    Proclinical are proud to announce our exclusive partnership with Ultragenyx Pharmaceuticals in support of their ongoing European expansion. Ultragenyx are a US based biotech committed to the development of innovative therapies for patients with serious rare and ultra-rare genetic diseases. Their unique approach has led to the successful development of...

  • Director, Commercial Development, Drug Product

    Vor 7 Tagen

    Basel, Schweiz Lonza Vollzeit

    Switzerland, BaselToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...

  • Director, Commercial Development, Drug Product

    vor 7 Monaten

    Basel, Schweiz Lonza Vollzeit

    Switzerland, BaselToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...

  • Technical Project

    vor 7 Monaten

    Basel, Schweiz CTC Resourcing Solutions Vollzeit

    **Technical Project & Product Lead - Drug Product (Oral Dosage) - 5752 ADA** Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking for a **Technical Project & Product Lead - Drug Product (Oral...