A global pharmaceutical company with a local office based in Zug Canton is looking for an experienced Quality Assurance Manager to join their team.
This Senior Quality Assurance Manager (GDP) role will focus on project in the area of quality systems management within distribution and warehousing.
- Ensures GDP requirements applicable to the activities outlined by the corporate procedural documents related to GDP and any update from regulations are communicated to relevant departments.
- Ensures personnel involved in distribution activities at Global Capabilities Hub (GCH) maintain competence in GDP through regular training.
- Ensures that medicines are supplied and traded according to GDP.
- Supports the organization in fighting counterfeit medicinal products according to guidelines issued by the relevant Swiss and EU authorities and the agreements in place.
- Negotiates Quality Agreements including responsibilities relating to wholesale distribution and/or product transportation.
- Ensures that suppliers and customers are qualified,
- Ensures that quality of the medicinal products is guaranteed from receipt of the goods throughout the entire distribution channel to the end of the responsibility of the company regulations GCH and distribution documentation is recorded and traceable.
- Ensures that self-inspections are performed and inspection readiness.
- Assures the establishment license is maintained.
- Lead GDP Management review activities including GDP metric review.
- Coordinate and promptly perform any recall operations for medicinal products.
- Approves any returns to saleable stock and trend stock returns.
- Approves procedures applicable to wholesale distributor's activities.
- Ensures applicable documentation is complete and current, and delegation documentation is maintained when required.
- Provides directives in business operating area to applicable GCH employees and makes decision.
- The responsibilities of a RP are described in art. 5, art. 10, art. 14 and art. 15 of the MPLO.
- Bachelor degree in a relevant scientific discipline e.g. Biochemistry, Microbiology, Pharmacy, Biological Sciences or related Pharmaceutical Science is required.
- Previous experience as Responsible Person or Qualified Person as well as understanding of the Swiss laws & ordinances in accordance with the Swiss Medicines Inspectorate (I-SMI.TI.17).
- Minimum 5 years of experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency.
- Proficient in cGMPs, cGDPs and regulations promulgated by the FDA, EMA or equivalent regulatory Agencies.
- Extensive experience and technical knowledge in wholesale distribution operations which enables first-hand knowledge of good distribution practice, transportation, quality assurance. Demonstrated knowledge of and training in GDP.
- In depth knowledge of GDP regulations pertinent to the USA, EU and other international markets.
- Direct experience interacting, effectively communicating with Health Authorities; managing Health Authority inspections.
- Extensive experience and technical knowledge in chemical, biological and/or pharmaceutical operations which enables first-hand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences.
- Ability to deal and influence effectively all levels of management to ensure that decisions regarding quality are taken independently and build relationships, partnerships and influence and/or enforce quality decisions.
- Proficiency with global system (e.g Trackwise, SAP, Microsoft Office) as well as strong negotiation, communication and presentation skills
- Demonstrated technical expertise in resolution of deviations, development of effective CAPA and use of risk assessments.
- Be highly proficient in English - Fluency in German of advantage.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Beata Klecz on 0203 0789 551 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.