Job Description
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 biop...