* 22 August 2026
* 80 - 100%
* Permanent position
* Hettlingen CH
**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.
**For recruitment agencies:**
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.
