Role and responsibilities

Act as the Responsible Person (RP) / Fachtechnisch verantwortliche Person (FvP) in accordance with Swiss regulatory requirements (HMG, AMBV) and Swissmedic Technical Interpretation I-SMI.TI.17. Ensure compliance with applicable GMP requirements and regulatory commitments across manufacturing operations. Assess quality-critical issues and support decision-making related to product quality, compliance, and patient safety. Serve as the primary contact for Swissmedic and represent the company during inspections and regulatory audits. Act as an independent quality authority and trusted partner, balancing compliance, quality, and business needs.

Team / description

Ophtapharm AG is an FDA/EU-GMP certified pharmaceutical manufacturer specializing in ophthalmic products. At our production site in Hettlingen near Winterthur, we aseptically manufacture, fill, and package high-quality products such as eye drops, ointments, and gels for international markets.

Qualifications and Skills

MSc or PhD in Pharmacy, Chemistry, Biology, or a related scientific discipline.
Eligible to act as the Responsible Person (RP) / Fachtechnisch verantwortliche Person (FvP) under Swiss regulatory requirements, with the professional qualifications and experience required for Swissmedic recognition.
Minimum 5-7 years of experience in sterile pharmaceutical manufacturing within a GMP-regulated environment.
Strong expertise in GMP and regulatory requirements, with sound judgement in quality-critical matters and a solid understanding of manufacturing processes and customer requirements.
Credible communicator with an independent, pragmatic, and solution-oriented mindset; fluent in English and German, both written and spoken.