Sr Batch Reviewer

We are supporting a dynamic biotech manufacturing site in their search for a Sr QA Officer focused on Batch Record Review and documentation oversight. This is a 6-month contract (extension highly likely) and offers a hands-on role within a collaborative QA team.  

This is a full-time role with on-site presence required 4 days/week in a fast-paced, regulated manufacturing environment.

Key Responsibilities:

• Review GMP batch records for completeness, accuracy, and compliance with internal procedures and regulatory standards

• Identify documentation gaps or deviations, and work cross-functionally with production, QA, and QC to resolve discrepancies

• Ensure timely and compliant documentation for product release

• Support preparation for internal and external audits through document readiness

• Contribute to documentation system improvements and QA processes as needed

• Collaborate closely with the QA team to maintain quality standards across manufacturing activities

Essential Requirements:

• 2–7 years of QA experience in a GMP-regulated manufacturing environment (biotech or pharma)

• +3 years experience with batch record review in GMP environment

• Familiarity with CAPAs, deviations, and change control processes

• Fluency in Dutch is required

• Comfortable working in a structured, documentation-focused QA role

• Strong communication and cross-functional collaboration skills

Desirable Requirements:

• Experience working in smaller biotech or CDMO environments 

• Familiarity with documentation systems such as Veeva, MasterControl, or TrackWise

• Prior involvement in audit readiness and inspection support

• Interest in continuous improvement and documentation workflow optimization

Additional Insights:

• Start Date: ASAP – ideally December, or January

• Duration: 6-month contract (extension likely)

• Employment Type: Contractor

• Hours: 40

• On-Site Presence: Ideally 4 days/week  

• Interview Process: 1-stage interview; back-to-back slots preferred for shortlisted candidates