TRD QA Specialist

Job description

Job Description Summary Location: Ivrea, Italy #onsite Role Purpose: During the pilot plant ramp up and operationalization support line units efforts in developing compliant manufacturing and QC-related quality system, with particular focus on master batch records, logbooks, forms, procedures. Oversee the manufacturing lines initial validation activities (e.g. water runs, engineering batches and eventually APSs) and QC laboratory instruments PQs. In routine will be responsible to coordinate the QA shopfloor team and perform manufacturing and QC oversight, deviation and OOX review/approval, batch record review and support QP for the release of phase I/II clinical products. Job Description: Major Accountabilities: Support the pilot plant ramp‑up and operationalization by contributing to the development, implementation, and maintenance of a compliant manufacturing and QC quality system, with particular focus on master batch records, logbooks, forms, and GMP procedures. Oversee and support initial manufacturing and QC validation activities, including water runs, engineering batches, APSs, and QC laboratory instrument Performance Qualifications (PQs), ensuring documentation completeness...