Senior Specialist, Quality Assurance (Fixed Term)

What you’ll do • Review executed batch records, logbooks, and documentation to ensure compliance with cGMP and GDocP. • Compile lot genealogy and disposition packages to drive timely product release. • Provide QA oversight for product status, shipping documents, and quality tag-out systems. • Support and approve deviation investigations, CAPA implementation, and timely closure of quality events. • Oversee and approve changes to operational documents (e.g., MBRs, SOPs, Forms, Logbooks). • Participate in QA shopfloor activities, changeovers, walkdowns, and audits (regulatory/customer). • Lead and coordinate site projects, investigations, and change controls as needed. What we’re looking for• Degree or Diploma in Science or Engineering. • Experience in Quality Assurance within a cGMP manufacturing environment, ideally in Cell and Gene Therapy (CGT) or biopharmaceuticals. • Strong knowledge of cGMP, GDocP, and applicable regulatory requirements. • Hands-on experience with batch record review, deviation management, and CAPA implementation. • Proven ability to lead investigations, change controls, and cross-functional projects. • Effective communication and stakeholder management skills.