Batch Record Reviewer

Batch Record Reviewer | Pharmaceutical Manufacturing | GMP Batch Documentation & Compliance Support

 

Company Description

A pharmaceutical manufacturing organisation dedicated to ensuring that all production activities comply with internal procedures, regulatory expectations, and cGMP standards. The site collaborates closely with QA, Production, and operational teams to uphold high-quality manufacturing practices and maintain robust batch documentation processes.

 

Job Description

As a Batch Record Reviewer, you will ensure that all executed batch records and associated manufacturing documentation are complete, compliant, and prepared according to approved procedures and regulatory requirements. You will work independently while collaborating with QA Managers and operational teams to clarify comments, resolve documentation issues, and support batch release. You will also assist in initiating deviations and investigations related to batch record observations.

 

Key Responsibilities

• Review executed batch records and production documentation, including raw data, in accordance with procedures and regulatory standards
• Ensure the documentation package is complete to support timely batch release
• Evaluate comments added to executed batch records and clarify necessary points with operations
• Collaborate with the responsible QA Manager on documentation assessments
• Support the initiation of deviations and investigations for observations identified during batch record review

Essential Requirements

• Academic degree or relevant work experience in Biology, Chemistry, Biotechnology, or a related field
• Previous experience in a GMP-regulated pharmaceutical or API environment is an advantage
• Strong ability to identify non-compliance and gaps versus quality standards
• Structured, precise, and well-organised working style
• Open-minded, motivated, and able to work independently
• Fluent English (spoken and written); German is an advantage

 

Additional Insights

Location: Visp. Switzerland

Department: Quality / Batch Documentation Review

 

Interested? Please send your CV to Miguel Gomes at m.gomes@panda-int.com or reach out directly at +31 20 20 44 502.