QA Analyst

Overview

In this fixed-term role, you will support GMP-compliant batch release by coordinating and reviewing batch documentation for QP certification. You’ll work cross-functionally with production, supply chain, QC and QP to ensure timely product release with data integrity. You will handle batch tracking, documentation control, and quality system tasks while contributing to process improvements. This position offers the chance to impact product quality and regulatory compliance in a global pharmaceutical setting.

Responsibilities

• Prepare and review batch documentation for QP certification per EU GMP Annex 16
• Perform batch reviews including production checks and formulation sheet reviews
• Operate quality-related tasks in systems like LIMS and SAP for batch release
• Participate in batch tracking and communicate issues to stakeholders
• Support batch record review and process improvement projects
• Manage archiving and handling of batch documentation and in-process docs
• Assist with deviation management, investigations, and change control
• Contribute to document control processes and internal audits/quality system maintenance
• Ensure compliance with EU GMP, internal procedures, and regulatory/biosafety requirements

Key requirements

• Understanding of GMP principles and data integrity
• Experience in a quality system environment within regulated industry (advantageous)
• Familiarity with batch record review or similar QA activities (preferred)
• Ability to work with quality and business systems (LIMS, SAP)
• Strong attention to detail and ability to review technical documentation
• Good organizational and prioritization skills in a dynamic environment
• Effective written and verbal communication across functions
• Proactive and solution-oriented with collaborative problem-solving
• Basic proficiency in Microsoft Office tools
• DBS check required for successful candidate
• Educational background in a scientific field would be advantageous

• attention to detail
• cross-functional collaboration
• clear communication
• GMP and data integrity
• LIMS
• SAP

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