Ophtapharm AG
Manager QA Operations & FvP (m/w) 100%
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
https://www.google.com/maps/embed/v1/place?key=AIzaSyCUSSd0XvFdsKF3c_S51vVM2aIeI7m-1V0&language=de&zoom=16&q=Riethofstrasse+1%2C8442%2CHettlingen+CH%2CSchweiz
Haben Sie Fragen?
HR Hettlingen, Human Resources, beantwortet Ihnen diese gerne. Tel: +41 52 304 13 23.