QA Analyst

Boehringer Ingelheim; Old Woking; On-site; GBP 38,000 - 50,000; Full time

Job summary

Boehringer Ingelheim is seeking a Quality Assurance Analyst in the UK to support batch release activities and ensure regulatory compliance with GMP. The role involves coordinating batch documentation, supporting QP certification, and contributing to process improvements.

Fixed-term contract until 31 December 2027, requiring collaboration with production, supply chain, QC, and QP to ensure timely and compliant product release.

Qualifications

• Experience in GMP and data integrity in regulated industries.
• Familiarity with batch record review processes in pharma.
• Ability to use quality and business systems (LIMS, SAP).
• Strong attention to detail with technical documentation.
• Excellent communication and organisational skills.
• Degree in a scientific field is advantageous.

Responsibilities

• Prepare and review batch documentation for QP certification.
• Coordinate batch review activities and production checks.
• Support batch release projects and process improvements.
• Manage archiving and document control for batch records.
• Provide operational support and assist with deviations, investigations, change control.
• Contribute to internal audits and quality system maintenance.
• Ensure compliance with EU GMP and regulatory requirements.

Skills

GMP knowledge

Data integrity

Attention to detail

Organisational skills

Communication skills

Cross-functional collab

Quality systems

Problem solving

MS Office

Education

Science degree

Tools

LIMS

SAP

Job description

THE POSITION The Quality Assurance Analyst plays a key role in ensuring that batch release activities are performed accurately and in compliance with applicable regulatory requirements and internal quality standards. This position focuses on the review and coordination of batch documentation, supporting timely product release while maintaining high standards of data integrity and Good Manufacturing Practice (GMP). Working cross-functionally with production, supply chain, quality control and the Qualified Person (QP), the role contributes directly to the safe and efficient release of products. This is a fixed-term contract until 31st December 2027.

Tasks and Responsibilities

• Prepare and review batch‑specific documentation to ensure completeness and accuracy prior to Qualified Person (QP) certification, in alignment with EudraLex Volume 4, Annex 16Perform additional batch review activities, including production checks and formulation sheet reviewsExecute quality‑related tasks within systems
• such as LIMS and SAP relevant to batch release processesParticipate in batch tracking activities and communicate quality‑related issues to relevant stakeholders in a timely mannerSupport projects and initiatives related to batch record review and process improvementManage archiving and handling of batch documentation, including in‑process documentation controlProvide operational support in line with business needs, including
• Supporting deviation management, investigations and change controlAssisting with document control processesParticipating in internal audits and quality system maintenanceEnsure compliance with EU GMP, internal procedures, and applicable regulatory and biosafety requirements

Requirements

• Understanding of Good Manufacturing Practice (GMP) principles and data integrity requirementsExperience working in a quality system environment within a regulated industry (e.g. pharmaceutical or biologics manufacturing) is advantageousFamiliarity with batch record review processes or similar quality assurance activities is preferredAbility to work with quality and business systems (e.g. LIMS, SAP or equivalent)Strong attention to detail and ability to review technical documentation accuratelyWell‑developed organisational and prioritisation skills, with the ability to manage multiple tasks in a dynamic environmentEffective communication skills, both written and verbal, with the ability to collaborate across
• functions and with different stakeholdersProactive and solution‑oriented mindset with a collaborative approach to problem‑solvingBasic proficiency in Microsoft Office tools (e.g. Excel, PowerPoint, Outlook)A degree or educational background in a scientific or related field would be advantageous

Please note: a Disclosure and Barring Service (DBS) check will be required for the successful candidate. Any offer of employment will be subject to a satisfactory DBS certificate.

WHY THIS IS A GREAT PLACE TO WORK

Boehringer Ingelheim has been recognised as a Top Employer in the UK, demonstrating our commitment to building an exceptional workplace through strong people practices and supportive HR policies.

To learn more about why BI is a great place to work, visit