QA Analyst
Boehringer Ingelheim, Mount Hermon, Woking
QA Analyst
Salary not available. View on company website.
Boehringer Ingelheim, Mount Hermon, Woking
- Full time
- Temporary
- Onsite working
Posted 6 days ago, 11 Aug | Get your application in now to be included in the first week's applications.
Closing date: Closing date not specified
Job ref: 5808c43d50814eff96601157f22123aa
Location ref: Mount Hermon, Woking
Full Job Description
THE POSITIONThe 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 ResponsibilitiesPrepare 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 requirementsRequirementsUnderstanding 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 advantageousPlease 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 WORKBoehringer 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