Lupin
Website:
lupin.com
Job details:
Job Description
JD:
Design, Preparation and Review of documents related to manufacturing – 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 review and approve, 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
Experience around 7-10 years.
Education
Graduation in Pharmacy
Masters in Pharmacy
Competencies
Innovation & Creativity
Result Orientation
Collaboration
Customer Centricity
Developing Talent
Stakeholder Management
Strategic Agility
Process Excellence
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