QA Specialist - Batch Record Reviewer
Location: Valais, Switzerland (Onsite)
Contract: 6-Month Fixed-Term Contract
Start Date: Immediate
About the Role
We are currently seeking a Batch Record Reviewer to join a leading pharmaceutical manufacturing environment in Visp. This position is ideal for a detail-oriented professional with experience in GMP-regulated manufacturing or batch record review who is available to start immediately.
Working closely with Manufacturing and Quality teams, you will ensure the accuracy, completeness, and compliance of electronic batch records, supporting efficient batch release activities and overall quality compliance.
Key Responsibilities
- Perform timely and independent review of executed electronic batch records (eBRs) within MES Syncade.
- Ensure batch records are accurately completed, compliant, and ready for QA review.
- Identify documentation discrepancies, compliance gaps, and quality-related issues.
- Collaborate with Manufacturing, Operations, and Quality teams to investigate and resolve documentation observations.
- Initiate and support the management of Deviations and CAPAs related to batch record review findings.
- Support the preparation of documentation packages to facilitate timely QA batch release.
- Ensure compliance with GMP and GDP requirements throughout the review process.
- Contribute to continuous improvement initiatives focused on documentation quality and operational excellence.
Required Qualifications
- Previous experience in a GMP and/or GDP-regulated pharmaceutical, biotechnology, or API manufacturing environment .
- Experience in Batch Record Review (preferably electronic batch records) or within GMP Manufacturing Operations.
- Strong understanding of GMP documentation requirements, deviations, CAPAs, and compliance processes.
- Ability to identify non-compliance issues and documentation gaps against quality standards.
- Experience with MES systems , ideally Syncade , is highly desirable.
- Fluent in English (written and spoken).
- German is a strong advantage.
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QA Batch Review Specialist Arbeitgeber: Gi Group
Unser Kunde in der Region Olten ist ein hervorragender Arbeitgeber, der seinen Mitarbeitenden nicht nur kostenlose Parkplätze und eine gründliche Einarbeitung bietet, sondern auch ein angenehmes Arbeitsumfeld fördert. Die flexible Schichtarbeit ermöglicht es den Mitarbeitenden, ihre Work-Life-Balance zu gestalten, während die Möglichkeit zur Übernahme von Verantwortung und die Unterstützung bei der persönlichen Weiterentwicklung wertvolle Wachstumschancen bieten. Hier wird Teamarbeit großgeschrieben, und die positive Unternehmenskultur sorgt dafür, dass sich jeder Mitarbeiter geschätzt und motiviert fühlt.
