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.
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.
Haben Sie Fragen?
HR Hettlingen, Human Resources, beantwortet Ihnen diese gerne. Tel: +41 52 304 13 23.
As an established pharmaceutical niche company, we are pursuing the goal of improving the lives of patients with our products in the field of ophthalmologic products.
With over 40 years of experience in sterile manufacturing, we produce a wide range of products in liquid and semi-solid dosage forms at our Hettlingen and Winterthur sites.
