Batch Record Review Manager

Ophtapharm AG is an FDA/EU-GMP certified manufacturer of pharmaceutical ophthalmic products. On our plant in Hettlingen (Winterthur) high quality products such as sterile eye drops, eye ointments and eye gels are compounded, aseptically filled and packed for internal markets.

We seek on open position for our department QA Operations soon as possible:

Batch Record Review Manager

Your responsibilities

• Leading the batch record review team with 4 batch record reviewers
• Review of executed Batch Records
• Enable timely batch release
• Clarification of comments in batch records (together with operations)
• Initiate deviations as part of findings during batch record review

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

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