Review of the batch manufacturing and packing records and the supporting records like API COA, Inprocess results, packaging labels, etc., associated with validations, new products and periodic batch record reviews.
Change Controls:
Life cycle management of change control in Global Trackwise system.
Initiate change controls related to EMSO but not limited to the batch manufacturing and packing records, specifications and analytical method of analysis, stability protocols etc., that are received from the CMOs.
Deviations and CAPA Management
Logging and review of the deviations related to EMSO that are received from various CMO/Suppliers related to:
Deviations including manufacturing,
Complaints that includes investigations at the manufacturing site.
Process Validation:
Review of process validation/verification protocol, reports and associated batch documents.
NTM/GNTM Impact and Risk Assessment:
Coordinate with the CMOs for impact assessment of the GNTMs and provide the impact assessment to the Regional NTM Coordinator.
Qualification & Experience
Minimum 6 years of Manufacturing experience in pharmaceutical industry
Knowledge of cGMP, Quality management Systems and the pharmaceutical manufacturing, supply chain environment
Knowledge on Compliance Standards and Regulation as applicable to the market.
Experience of handling Operational Quality, QA exposure and External / Contract manufacturing sites