Quality Assurance Specialist - Batch Release & Validation

About the role

The Quality Assurance (QA) Specialist partners with site GMP operations and the validation team to solve complex problems and ensure quality, safety, reliability and efficiency. The role covers multiple quality systems such as change controls, validation, deviations, laboratory investigations and CAPAs, and supports daily operations including batch record review, batch disposition and release, and continuous improvement projects.

Key responsibilities

• Review and approve batch records and oversee the batch release process in line with GMP and regulatory requirements
• Lead complex root cause investigations for batches affected by deviations or laboratory investigations
• Monitor batch release performance and CAPA progress, and collaborate on problem prevention and system improvements
• Implement continuous improvement initiatives and represent the site in the CoP for batch release
• Review qualification and validation documentation (protocols, reports, risk assessments, traceability matrices) and change controls, and ensure compliance with regulations such as FDA and EMA
• Audit production processes, support internal and external audits and regulatory inspections, and develop risk management strategies
• Coordinate the Annual Product Review, take part in GEMBA walks, run the daily Level 2 quality meeting and act as backup for the QA Executive and QA specialists
• Complete mandatory GMP training and follow HSE guidelines and the Zero Incident mindset

Required profile

• Engineering or science degree or equivalent from a recognised institution, with 3-5 years of quality operations experience in the pharmaceutical industry
• Experience in batch release, deviation and investigation handling is preferred
• Quick learner with a proactive, adaptable approach to changing priorities and manufacturing schedules
• Strong time management, attention to detail and ability to work independently and write and review reports
• Good verbal and written communication and presentation skills