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 mana...