Quality Assurance
Current- Revision and approval of the API, raw materials, packaging components, bulk and finish product release specifications.
- Review and approval of the bulk and packaged batch records and related documents.
- Review and approval of the analytical data related to the industrial products and/or components according to the internal SOPs, including OOS, OOT and deviations.
- Issue, review and approve documents and sign the certificates of analysis of batches manufactured for release or for regulatory purposes on different countries to be marketed.
- Issue and approve certificate of analysis related to raw materials.
- Approve and/or reject batches of product (bulk and finished), raw materials and packaging materials in SAP system.