Administrator Qualification / Validation Production Facilities (m/f) 100 %
Ophtapharm AG
Hettlingen CH
Key information
- Publication date:21 October 2025
- Workload:100%
- Contract type:Permanent position
- Place of work:Hettlingen CH
Job summary
Ophtapharm AG is a certified producer in pharmaceuticals (ophthalmics). Join our dynamic team in Hettlingen!
Tasks
- Conduct qualification projects for production systems and document processes.
- Perform cleanroom qualifications and airflow visualizations as per ISO 14644.
- Support validation projects and process optimization initiatives.
Skills
- Technical/scientific background in pharma, with 5+ years in qualifications.
- Strong knowledge of GMP regulations (EU, FDA) and aseptic production.
- Excellent communication skills in German and English.
Is this helpful?
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.
Administrator Qualification / Validation Production Facilities (m/f) 100 %
To strengthen our team in Hettlingen, we are looking for a
Your tasks
- Planning and execution of equipment qualifications, including the necessary documentation for aseptic manufacturing and packaging processes
- Cleanroom qualifications and flow visualizations (smoke studies) according to ISO 14644
- Support in qualification and validation projects
- Developing problem solutions
- Participation in process optimization projects
- Creation and training of required guidelines and SOPs
- Representation of the department during regulatory inspections and customer audits
Your profile
- Technical and scientific education (pharmaceutical/process/food technology)
- At least 5 years of experience in equipment qualification
- Several years of GMP experience (EU, FDA)
- Confident knowledge of relevant regulatory requirements
- Knowledge of pharmaceutical aseptic production technology and processes
- Very good German and English skills, spoken and written
- Good communication skills as a contact point for many departments
Your benefits
- Dynamic environment with development opportunities
- Possibility of partial home office (depending on function)
- In our uncomplicated company culture, we clearly prefer "du" over "Sie" (informal address)
- Free parking and public transport connections within walking distance
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.
