QA Batch Review Specialist

Gi Group; Oberwallis; On-site; CHF 90,000 - 120,000; Full time

Job summary

Gi Group seeks a QA Specialist - Batch Record Reviewer in Visp, Valais, Switzerland. This onsite role focuses on independent review of electronic batch records within a GMP/GDP framework to support timely batch release and quality compliance.

The candidate will work with Manufacturing and Quality to identify gaps, investigate deviations and CAPAs, and ensure documentation integrity throughout the review process.

Qualifications

• Experience in GMP/GDP-regulated pharma manufacturing environments.
• Experience with Batch Record Review (electronic) or GMP Manufacturing Operations.
• Strong understanding of GMP documentation, deviations, CAPAs, and compliance processes.
• Ability to identify non-compliance issues and documentation gaps against quality standards.
• Experience with MES systems, ideally Syncade.
• Fluent in English (written and spoken).
• German language is a strong advantage.

Responsibilities

• Review executed electronic batch records (eBRs) for accuracy and compliance.
• Ensure batch records are complete and ready for QA review.
• Identify documentation discrepancies and quality issues.
• Collaborate with Manufacturing, Operations and Quality to resolve observations.
• Support Deviations and CAPAs related to batch record review findings.
• Assist in preparing documentation packages to enable timely QA batch release.
• Ensure GMP/GDP compliance throughout the review process.
• Contribute to documentation quality and operational excellence improvements.

Skills

GMP Regulations

GDP Regulations

Batch Record Review

GXP Documentation

Syncade MES

English Proficiency

German Language

Tools

Syncade MES

Job description

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.