Quality Assurance Analyst
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. The 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.
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.
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