Principal Consultant – Quality and Regulatory
I am looking for a Quality Batch Record Reviewer to join a Pharmaceutical Manufacturing organisation based in Visp, Switzerland. The Batch Record Reviewer is responsible for reviewing and approving manufacturing and packaging batch records to ensure compliance with cGMP regulations, internal SOPs, and regulatory requirements. This role is critical in ensuring product quality and timely release of pharmaceutical products. This is a full time on-site role
Responsibilities
* Review completed electronic 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 documentation related deviations in a timely manner and support corresponding investigation, as well as definition of CAPAs.
* Participate in documentation and electronic batch records change requests.
Qualifications
* Professional experience in GMP production environment, quality procedures and SOP execution and/or Bachelor’s/Master’s Degree or equivalent experience.
* Preferred area of study: Pharmaceutical Technology, Biotechnology, Chemistry, Pharmacy or equivalent scientific degree.
Required Skills
* Experience in (electronic) batch record review is highly preferred.
* Knowledge in Trackwise, SAP and MES is a plus.
* Fluent German
* GMP experience (min. 2 years).
Preferred Skills
* Experience in (electronic) batch record review is highly preferred.
Seniority level
* Associate
Employment type
* Contract
Job function
* Quality Assurance
Industries
* Pharmaceutical Manufacturing
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