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This job description provides comprehensive information about the role, responsibilities, requirements, and benefits. However, it could benefit from improved formatting for better readability and focus. Minor adjustments with appropriate HTML tags can enhance user engagement and clarity. Here's a refined version: Base Pay RangeProvided by BioTalent. Your actual pay will depend on your skills and experience — discuss with your recruiter to learn more. Job TitleSenior Quality Assurance Specialist in Pharma and Biopharma - BioTalent LocationLondon – Competitive Package About the RoleBioTalent is supporting an ATMP organization in recruiting a QA Operations Specialist. You will play a critical role in ensuring GMP compliance in manufacturing operations, supporting the production of life-changing cell and gene therapies. This role involves working Wednesday-Saturday or Sunday-Wednesday shifts, with a 13% shift allowance. Key ResponsibilitiesProvide quality oversight of GMP manufacturing activities to ensure compliance with regulatory requirements. Support batch review and release processes, including documentation review and deviation assessments. Participate in investigations of deviations, CAPAs, and change controls, ensuring timely resolution and continuous improvement. Conduct GMP audits and inspections of manufacturing areas, ensuring adherence to SOPs and quality standards. Review and approve manufacturing and laboratory records, including equipment qualification and validation protocols. Act as a QA liaison between production, QC, and regulatory teams to maintain high-quality standards. Support regulatory submissions and inspections (MHRA, FDA, EMA), ensuring readiness and compliance. Provide training and mentorship to manufacturing teams on quality and compliance best practices. RequirementsExperience in GMP quality assurance within a pharmaceutical or biotech environment, preferably in ATMP, cell therapy, gene therapy, or biologics. Strong understanding of GMP, GDP, and relevant regulatory guidelines (MHRA, EMA, FDA, ICH, Eudralex). Experience with quality systems such as deviations, CAPAs, change control, and batch record review. Excellent attention to detail, problem-solving skills, and ability to work in a fast-paced environment. Strong communication and collaboration skills, with cross-functional experience. What’s in it for you?Be part of a cutting-edge biopharmaceutical company making a real impact on patients' lives. Work in an innovative and fast-growing ATMP environment. Competitive salary and benefits, including career growth opportunities. A supportive and collaborative team culture. Apply now and advance your QA career with an exciting ATMP company! Additional DetailsSeniority level: Associate Employment type: Full-time Job functions: Quality Assurance, Manufacturing, Science Industries: Pharmaceutical Manufacturing, Biotechnology Research, Medical Equipment Manufacturing#J-18808-Ljbffr