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.
As the Responsible Person (FvP) you are responsible for providing leadership and oversight of Quality Compliance matters across the commercial entity in support of the quality System. By law, the Responsible Person is directly accountable for the technical supervision of operations, guaranteeing the safety, efficacy and quality of the medicines.
We are looking for a pragmatic and influential professional as Responsible Person (RP) / Fachtechnisch verantwortliche Person (FvP) (60–100%), starting immediately or by mutual agreement.
Responsible Person (RP) / Fachtechnisch verantwortliche Person (FvP) (60-100%)
Your Role
- 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.
Your Profile
- 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.
What you can expect
- A highly visible role with direct influence on product quality, compliance and business-critical decisions.
- The opportunity to leave your mark on a company undergoing transformation and actively shape its future quality organization.
- Broad responsibilities and close collaboration with key stakeholders across the business.
- Short decision-making paths, pragmatic solutions and the ability to make a tangible impact.
- Attractive pension scheme, free parking and convenient access by public transport.
For recruitment agencies:Thank you for your interest. We are not engaging external support for this role.
Arbeitsort
Ophtapharm AG
Riethofstrasse 1
8442
Hettlingen CH