Address Review of analytical document review. Review and approval of Specification and STPs. Review of instrument qualification documents. Review of Investigations and assessing Change controls. Should have knowledge on software compliance and should support in Audit trail review and CSV.
- Review of Analytical documents of Raw materials, packing materials, In process, Hold time, finished product, stability, Analytical method transfer/Validation/Verifications protocol, reports, and raw data.
- Review and approval of Specifications for API, Excipients, packing materials, in process, finished product and stability.
- Review of qualification documents (IQ/OQ/PQ) of equipment’s/instruments.
- Investigation and review reports of laboratory OOS, OOT, Incidents. Discussion of QMS action points with CFT and to make sure the closure within TCD.
- Provide support in assessing Change Control requests. And
- Computer System Validation (CSV) deliverable preparation/review.
