QA Analyst

Boehringer Ingelheim; Pirbright; Presencial; GBP 42.000 - 60.000; Jornada completa

Descripción de la vacante

Boehringer Ingelheim is seeking a Quality Assurance Analyst to support batch release activities under GMP, ensuring accurate documentation and timely product release. The role collaborates with production, supply chain, QC and the QP to maintain data integrity and regulatory compliance.

The position is a fixed-term contract until 31 December 2027, based in the UK. Candidates should have GMP knowledge, experience in regulated environments, and familiarity with LIMS/SAP, with strong attention to

Formación

• Understanding GMP principles and data integrity
• Experience in a regulated industry (pharmaceutical/biologics) is advantageous
• Familiarity with batch record review processes
• Ability to work with quality and business systems (LIMS, SAP)
• Strong attention to detail and ability to review technical documentation accurately
• Well-developed organisational and prioritisation skills
• Effective written and verbal communication across functions
• DBS check required for successful candidate

Responsabilidades

• Prepare and review batch documentation for QP certification in line with Annex 16
• Conduct batch review activities including production checks and formulation sheet reviews
• Execute quality tasks in systems like LIMS and SAP related to batch release
• Support batch tracking and communicate quality issues to stakeholders
• Assist with batch record review projects and process improvements
• Archive and manage batch documentation and in-process docs
• Support deviation management, investigations and change control activities
• Assist with document control processes and participate in internal audits
• Ensure compliance with EU GMP and regulatory requirements

Conocimientos

GMP knowledge

Data integrity

Documentation review

Attention to detail

Cross-functional collaboration

Educación

Degree in scientific field

Herramientas

LIMS

SAP

Descripción del empleo

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.

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.

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 16
• Perform additional batch review activities, including production checks and formulation sheet reviews
• Execute quality-related tasks within systems such as LIMS and SAP relevant to batch release processes
• Participate in batch tracking activities and communicate quality-related issues to relevant stakeholders in a timely manner
• Support projects and initiatives related to batch record review and process improvement
• Manage archiving and handling of batch documentation, including in-process documentation control
• Provide operational support in line with business needs, including:
  • Supporting deviation management, investigations and change control
  • Assisting with document control processes
  • Participating in internal audits and quality system maintenance
• Ensure compliance with EU GMP, internal procedures, and applicable regulatory and biosafety requirements

Requirements

• Understanding of Good Manufacturing Practice (GMP) principles and data integrity requirements
• Experience working in a quality system environment within a regulated industry (e.g. pharmaceutical or biologics manufacturing) is advantageous
• Familiarity with batch record review processes or similar quality assurance activities is preferred
• Ability to work with quality and business systems (e.g. LIMS, SAP or equivalent)
• Strong attention to detail and ability to review technical documentation accurately
• Well-developed organisational and prioritisation skills, with the ability to manage multiple tasks in a dynamic environment
• Effective communication skills, both written and verbal, with the ability to collaborate across functions and with different stakeholders
• Proactive and solution-oriented mindset with a collaborative approach to problem-solving
• Basic 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: https://www.boehringer-ingelheim.co.uk/careers/uk-careers/why-great-place-work

Our Company

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.

Why Boehringer Ingelheim?

With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Want to learn more? Visit https://www.boehringer-ingelheim.com