JobdescriptionOn behalf of a client company, we are looking for a QA Batch Record Reviewer to ensure that production batches have been manufactured correctly, in accordance with established procedures and regulatory requirements. The ideal reviewer has great attention to detail, is able to work independently, and possesses a thorough knowledge of the manufacturing process they are reviewing.
Location: On-Site in Visp (no home office) - Dealing with paper-based documentation.
Key Responsibilities
- Review paper-based executed batch records within the specified timeframe.
- Track, report, and monitor batch record review and other relevant critical metrics to ensure on-time batch release.
- Raise meetings with Operations (Ops) related observations in a timely manner.
Requirements and Skills
- Professional experience in a GMP production environment, quality procedures, and SOP execution, and/or a Bachelor's/Master's Degree or equivalent experience. Preferred area of study: Pharmaceutical Technology, Biotechnology, Chemistry, Pharmacy, or equivalent scientific degree.
- Experience in batch record review is highly preferred.
- GMP experience (minimum 2 years).
- Great communication skills.
Additional Requirements
- Business fluent German is a MUST, English is preferred.
Luciana Sardo