Senior Executive

4 weeks ago


Pithampur, Madhya Pradesh, India LUPIN Full time

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 Work Experience 10 to 12 years Education Graduation in Pharmacy Competencies


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