Batch Record Review (BRR) Specialist – Clinical Manufacturing Visp, Switzerland – Full-time, 6-month contract (with a high chance of extension)
Company Description
This leading biopharmaceutical company, based in Visp, Switzerland, is a key player in the development and manufacturing of biologics. The site focuses on ensuring high-quality production standards for clinical and commercial materials, with a strong commitment to GMP compliance, patient safety, and continuous process improvement.
Job Description
As a Batch Record Review (BRR) Specialist, you will play a critical role in ensuring the accuracy, completeness, and compliance of electronic and paper-based batch records for various production campaigns. You will investigate deviations, process parameter failures, and operator comments, collaborating closely with cross-functional teams to resolve issues and maintain GMP standards.
Working within the BRR team and alongside Production, QA, and other technical departments, you will ensure batch records are reviewed in a timely and thorough manner, providing quality impact assessments and supplementary comments where necessary. Your role will also involve authoring post-production lifecycle documents and compiling cleaning report data, supporting the overall quality assurance of clinical manufacturing operations.
Key Responsibilities:
Review electronic and paper-based batch records in a timely manner using MES, Syncade, DeltaV, TrackWise, SAP, LIMS, and DMS systems.
Investigate deviations, failed process parameters, material consumption discrepancies, and operator comments, collaborating with cross-departmental teams to resolve issues.
Evaluate the correctness of batch record comments and actions, providing supplementary clarifications where required in strict adherence to GMP, Good Documentation Practices (GDP), and ALCOA+ principles.
Provide quality impact statements based on batch record investigations.
Support additional BRR team tasks, including post-production lifecycle document authoring and cleaning report data compilation.
Ensure full compliance with GMP and internal quality standards while maintaining timely deliverables.
Essential Requirements:
Bachelor’s degree or higher in Life Sciences, Biotechnology, or a related field.
Previous experience in production, batch record review, and/or quality assurance in a GMP environment is highly desirable.
Ability to work independently and manage tasks efficiently within target deadlines.
Strong English language skills; German reading proficiency is a plus.
Familiarity with GMP, GDP, and ALCOA+ principles.
Additional Insights:
Location: Visp, Switzerland (on-site role)
Contract Type: 6-month contract, with potential for extension
Start Date: ASAP
Language Requirements: English required; German reading skills preferred
Interested?
Send your CV to Khanyi Mabena at k.mabena@panda-int.com or reach out directly at +41445514407 to learn more.