Executive
Goa, GA, IN
Job Description
-
Design, Preparation and Review of documents related to manufacturing – Pas-X BMR’s for Scale up, Exhibit, Intended and Commercial manufacture of products, qualification, verification protocols, reports and MFC.
- Preparation and Review of Experimental batch report and scale up batch report.
- Compilation of batch data and preparation of Test Batch Validation / Monitoring Protocols (or) Reports and Process Validation Protocols (or) Reports.
-
To initiate and review change controls, incidents, deviations, CAPA, IPOOS, OOS, OOT, OOE, market complaints and other QAMS related activities.
- Execution and co-ordination for SAP related activities like loading of Masters of Semi Finished Goods (SFGs), Recipes and Bill of Materials (BOMs), for Semi Finished Goods (SFGs).
- Preparation and review of stability protocols for Experimental batches / Exhibit / Commercial Products / Intended commercial production.
- Prepartion of QRMs, Nitrosamine risk assesmemt, Regulatoru query response related to process development related query.
- Participation in self-inspection as auditees and compliance of the self-inspection observations.
Work Experience
5 to 8 years
Education
Competencies