Average salary: Rs408,157 /yearly
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- ...product meets specifications during the run. Sampling: Manage the collection of in-process samples blend samples stability samples and reserve samples according to the sampling plan. Documentation Review: Real-time review of Batch Manufacturing Records (BMR) and Batch...CollectionsFull time
- ...activities. Participate in investigations deviations OOS/OOT results and CAPA implementation related to validation. Maintain documentation and records in line with cGMP and data integrity requirements. Coordinate with cross-functional teams during audits and...SuggestedFull time
- ...-Grade lubricants for all moving parts and maintain a critical spares inventory to reduce Mean Time to Repair (MTTR). Logbook Documentation: Accurately record all maintenance activities parts replaced and machine Down Time in the equipment history cards and maintenance...SuggestedFull time
- ...Trial Monitoring: Supervise Scale-up and Exhibit batches to identify critical process parameters (CPPs) and ensure consistency. Documentation: Draft and review Technology Transfer Dossiers (TTD) Process Validation Protocols and Master Formula Records (MFR)....SuggestedFull time
- ...) and Batch Packing Records (BPR) to ensure 100% compliance with ALCOA principles. QMS Ownership: Lead the investigation and documentation of Deviations Change Controls and CAPAs .Ensure all Out of Specification (OOS) incidents in production are addressed and closed....SuggestedFull time
- ...in-process checks review batch records and support media fill validation sterility testing and equipment qualification . Documentation & Batch Records: Maintain BMR/BPR deviation reports and compliance documentation as per regulatory standards. Troubleshooting...SuggestedFull time
- ...Breakdown Analysis: Lead the troubleshooting of electrical failures using root cause analysis (RCA) and ensure that repairs are documented in compliance with cGMP standards. Statutory Compliance: Coordinate with external agencies for mandatory inspectionssuch as CEIG...SuggestedFull time
