Job Description

• Review and approval of Master Documents such as Batch manufacturing record /Batch packaging record, specification, Standard test procedure, Standard operating procedure, Qualification/ Validation protocols and reports.
• Preparation and review of Site Master File.
• Review and approval of Quality System document such as Deviation, Change Control, OOS, OOT and Annual product review.
• Handling of Market Complaints, FAR, Recall and Market withdrawal of Drug Products.
• Responsible for Vendor Qualification, Batch release & SAP related activity.
• To conduct self-audits and participation, review and implementation of regulatory and other audit compliance observation.
• To perform cGMP quality audits and compliance of Cross Functional Department, External Manufacturing Sites, Suppliers/Vendors, Contract Testing laboratories and service providers as applicable.
• To conduct management review meetings, site quality council meetings etc. and compilation of data, presentations and minutes of meetings.