Ophtapharm AG is an FDA/EU-GMP certified manufacturer of pharmaceutical ophthalmic products. At our site in Hettlingen (Winterthur) high quality products such as sterile eye drops, eye ointments and eye gels are compounded, aseptically filled and packed for international markets.
We seek on open position for our department QA Operations soon as possible
QA Product Manager
Your responsibilities
- Acting as first contact person for manufacturing projects regarding quality and compliance aspects internally and with customers
- QA Coordination in Tech Transfer Processes
- Approval of process related and analytical change requests
- Approval of Master Batch Record and of Product Specification
- Oversight of batch record review, deviations associated with batch release
- Management of Quality Agreements
- Participation in customer audits and inspections
Your Qualification
- Degree in natural sciences Chemistry / Pharmacy / Life Science / Material Management (FH, Bachelor, Master) or long-term experience as Lab Technician
- Profound GMP experience an Pharma environment, preferrable in sterile Drug Products
- Good knowledge in GMP, ISO and FDA regulations
- Good communication skills
- Very good English skills in verbal and written form
- Very good German skills in verbal form
- Joined-up thinking and assertiveness
Your Advantages
- Dynamic work environment and career opportunities
- In our company culture we prefer the personnel “You”
- Parking lots for free and close connection to the public transportation in walking distance
Arbeitsort
Ophtapharm AG
Riethofstrasse 1
8442
Hettlingen CH