Basel, Basel, Switzerland
- Lead product complaint investigations for suspected counterfeits of Roche marketed products. - Collaborate with manufacturing sites (internal sites, CMOs, suppliers, licensees) as well as globally situated affiliates to deliver complaint evaluations in a timely manner. - Present product complaint records and/or reports during periodic audits and regulatory inspections. - Develop, train, and mentor personnel and internal customers on relevant business processes. - Participate in weekly/monthly product quality meetings reporting key figures to multinational and multidisciplinary teams. - Serve as the Quality representative on cross-functional and multi-site teams.
- Lead product complaint investigations for Roche marketed products as well as suspected counterfeit investigations. - Deputy Head of Complaint Management Europe. - Collaborated with manufacturing sites (internal sites, CMOs, suppliers, licensees) as well as globally situated affiliates to deliver complaint evaluations in a timely manner. - Presented product complaint records and/or reports during periodic audits and regulatory inspections. - Developed, trained, and mentored personnel and internal customers on relevant business processes. - Participated in weekly/monthly product quality meetings reporting key complaint figures to multinational and multidisciplinary teams. - Served as the Quality representative on cross-functional and multi-site teams. - Provided, reviewed and approved APQR site module chapters and APQR E2E reports for complaints.
- Business and operational support of outsourced manufacturing activities in the business region. - Management of outsourced local manufacturing solutions (incl. performance metrics, key issues and highlights for senior management) - Primary contact for communication and resolution of production and technical issues. - Liaise, coach and support the countries in the implementation of necessary business processes - Risk Management (e.g. Regularly review Risk assessments for all local CMOs) - Representation in global governance councils - Selection of new outsourced solutions (e.g. Supported the collection of technical & operational requirements, participate in Due Diligence and audits, Facilitate communication to Headquarters functions, etc) Highlights: Project Lead for feasibility study of establishing an APAC Regional Packaging Hub in Singapore. Including high-level process and physical flows, annual costs (transportation and operations), regulatory/legal/IT input, complexity reduction, pros/cons of regional hub vs. as-is, roadmap with resources.
Internship in the galenical development of sterile dosage forms
Internship in the galenical manufacturing of sterile dosage forms