Ophtapharm AG is an FDA/EU-GMP certified manufacturer in the pharmaceutical sector (ophthalmic products). At our production site in Hettlingen near Winterthur, high-quality products such as eye drops, ointments, and gels are aseptically produced, filled, and packaged for international markets.
To support our team in Hettlingen, we are looking for a Manager QA Operations & FvP to join us as soon as possible.
Manager QA Operations & FvP (m/w) 100%
Ihre Aufgaben
• Act as the Responsible Person (FvP) acc. to Swiss Drug Law
• Manage and further develop the QA Operations Team
• Ensure batch disposition on time
• Manage key elements of a QA Operations including non conformities, complaints, CAPA, change control, risk management, PQR/APR, training
• Monitor Quality Metrics (Key Performance Indicators) accordingly
• Lead inspection readiness activities, represent your department in inspections and customer audits
• Lead the compendial compliance process
• Lead continuous improvement in the area of your responsibility
• Stay updated on industry trends, regulations and evolution of Health Authority expectations
• Deputize Director Quality
Ihr Profil
• PhD or MSc in Pharmacy, Biology, Microbiology or Chemistry
• Experience as Swiss FvP for sterile drug products and proven track with Swissmedic interactions
• 5-10 years of experience in GMP-regulated environments
• Proven experience in sterile drug product manufacturing is a must
• Demonstrated experience in Quality Assurance
• Strong leadership skills and significant experience as line manager
• Passionate for performance, drive improvement and innovation
• High degree of self-motivation/ proactively and results-oriented way of working
• Strong collaboration abilities and excellent communication skills as a point of contact across departments and functions
• Strong facilitation and organizational abilities.
Ihre Vorteile
• Dynamic environment with development opportunities
• Possibility of partially working remotely
• Free parking and public transport within walking distance
Please note that applications received through recruitment or placement agencies will not be considered.
Arbeitsort
Ophtapharm AG
Riethofstrasse 1
8442
Hettlingen CH