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
Haben Sie Fragen?
HR Hettlingen, Human Resources, beantwortet Ihnen diese gerne. Tel: +41 52 304 13 23.
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