Ophtapharm AG
Hettlingen CH
Senior Qualification & Validation Specialist (80-100%)
- 22 August 2026
- 80 – 100%
- Permanent position
- Hettlingen CH
Job summary
Join Ophtapharm AG, an FDA/EU-GMP certified producer of ophthalmic products. This is a chance to be part of a dynamic team in a growing company.
Tasks
- Plan and execute qualification and validation activities for systems.
- Ensure GMP compliance for systems and facilities in production.
- Support cross-functional projects and maintain quality standards.
Skills
- University degree in engineering or life sciences with relevant experience.
- Strong knowledge of GMP requirements and quality documentation.
- Excellent communication skills in German and English.
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About the job
Ophtapharm AG is an FDA/EU-GMP certified manufacturer in the pharmaceutical sector (ophthalmics). 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.
Senior Qualification & Validation Specialist (80-100%)
The Qualification & Validation team ensures the qualified and validated status of equipment, systems, premises, and processes, thereby making a significant contribution to the GMP-compliant manufacture of our ophthalmic medicinal products. It works closely with Production, Engineering, and Quality Assurance.
To strengthen our team, we are looking immediately or by arrangement for an experienced and committed person as Senior Qualification & Validation Specialist (80–100%).
Your role
- Planning, execution, and coordination of qualification and validation activities for equipment, systems, premises, and processes.
- Ensuring the qualified or validated status of GMP-relevant systems and facilities.
- Responsibility for qualifications, cleaning validations, CSV activities, and the associated GMP documentation.
- Participation in deviations, CAPAs, change controls, and product quality reviews (PQRs).
- Professional support for cross-departmental projects as well as active shaping of processes, standards, and compliance requirements.
Your profile
- Degree (university/technical college) in engineering, natural sciences, or a comparable field.
- Several years of professional experience in a GMP-regulated pharmaceutical or life sciences environment.
- Sound knowledge in qualification and validation, ideally in aseptic manufacturing.
- Confident handling of GMP requirements and quality-relevant documentation.
- Very good German and English skills as well as a structured and communicative working style.
What we offer
- Key role with direct influence on quality, compliance, and the further development of the site.
- Opportunity to actively shape processes, structures, and standards in a changing company.
- Broad area of responsibility with close collaboration across Quality, Production, and Engineering.
- Professional and personal development opportunities in a demanding GMP environment.
- Attractive pension scheme, free parking, and good accessibility by public transport.
Thank you for your interest. We do not work with external recruitment partners for filling this position.
Do you have questions?
HR Hettlingen, Human Resources, will be happy to answer them. Tel: +41 52 304 12 36.
HR Hettlingen, Human Resources, will be happy to answer them. Tel: +41 52 304 12 36.
