THE POSITION

As a QA Specialist in our Validation Team, you’ll play a crucial role in generating and revising validation documentation to support the validation of utilities, facilities, processes, and equipment. You’ll ensure that all commitments are met in accordance with established timelines and both internal and external validation regulations.
This is a hybrid role based in our manufacturing site in Pirbright, offering a unique opportunity to be part of a team that values quality and compliance.

REQUIREMENTS

• A Bachelor’s degree in Sciences, Engineering, Microbiology, or a related field, or formal qualification in validation or quality assurance
• A proven track record of success in similar roles, with comprehensive knowledge of EU GMP and Quality Assurance
• Hands-on experience with validation and qualification activities, preferably in a sterile or bio-pharmaceutical facility
• Strong analytical and problem-solving skills, with extensive knowledge of investigation techniques and tools
• Excellent communication skills, both written and verbal, with the ability to influence and present complex technical information
• Self-motivated and able to work independently while being a productive team player
• A collaborative, pragmatic, and solutions-focused approach with a ‘can do’ attitude
• Exceptional attention to detail and the ability to make sound decisions in a busy environment
• Proficiency in Microsoft Office and exposure to eQMS & eDMS systems (e.g., GoTrack, VQD)

• Lead the successful delivery of validation and qualification activities according to the Site Validation Master Plan (SVMP) for our Pirbright site
• Provide support for QA and validation activities for systems, processes, and procedures.
• Offer guidance for media fill validation and Aseptic Process Simulation (APS)
• Ensure validation activities are integrated into change controls and new projects
• Review and approve documentation such as SAT, FAT, and commissioning/decommissioning documents
• Act as a QA Representative to assist in maintaining quality systems, including deviation handling, investigations, change control, document control, and internal audits
• Interpret and apply regulations and policies during cross-functional meetings, fostering a culture of quality and validation compliance
• Guide and influence teams on GxP compliance and support colleagues in resolving issues, conducting risk assessments, and performing periodic reviews
• Actively support audit preparations and serve as an SME for validation, qualification, contamination control, and classified room validation audit topics