Senior Executive
- To prepare, review and submit dossiers for Life cycle management, and other submissions as required for EU region. - Preparation, review and submission of eCTD Renewal, variations, post marketing a
Find Pharma, Biotech, Clinical Research & Medical Jobs on Bioksha
- To prepare, review and submit dossiers for Life cycle management, and other submissions as required for EU region. - Preparation, review and submission of eCTD Renewal, variations, post marketing a
Key Responsibilities A. Analytical Method Development & Optimization Develop, optimize, and establish analytical methods for pharmaceutical formulations and development samples. Perform analyti
Execute manufacturing activities for API intermediates and finished active pharmaceutical ingredients as per approved Batch Manufacturing Records (BMRs), SOPs, and production plans. Operate and monit
Execute batch manufacturing activities as per Batch Manufacturing Record (BMR), SOPs, and approved process parameters. Operate and monitor reactors, centrifuges, ANFD, dryers, filters, and associated
Execute manufacturing activities for API intermediates and finished active pharmaceutical ingredients as per approved Batch Manufacturing Records (BMRs), SOPs, and production plans. Operate and monit
Review and approve batch manufacturing records (BMR), batch packaging records (BPR), logbooks, and analytical reports. Perform line clearance activities before and after manufacturing operations. Mo
Execute manufacturing activities for API intermediates and finished active pharmaceutical ingredients as per approved Batch Manufacturing Records (BMRs), SOPs, and production plans. Operate and monit
Execute manufacturing operations as per approved Batch Manufacturing Records (BMR), SOPs, and production plans. Supervise shift activities and ensure timely completion of production batches. Handle
Production : • To check the labels of raw material, packing materials and solvents before usage. • To maintain storage conditions of raw material/intermediates in plant. • To maintain process condi
Execute API manufacturing activities as per Batch Manufacturing Records (BMR) and SOPs. Monitor and control unit operations such as charging, reaction, filtration, centrifugation, drying, milling, bl
Perform routine analysis of raw materials, intermediates, finished products, stability samples, and cleaning validation samples. Operate and maintain analytical instruments such as HPLC, GC, UV-Visib
Execute API manufacturing activities as per Batch Manufacturing Records (BMR) and SOPs. Monitor and control unit operations such as charging, reaction, filtration, centrifugation, drying, milling, bl
• Ensure the c-GMP Compliance and schedule M compliance in production. • Ensure the completion of production targets with zero quality issue. • Ensure the compliance of inspection /Audit in coating
Execute API manufacturing activities as per Batch Manufacturing Records (BMR) and SOPs. Monitor and control unit operations such as charging, reaction, filtration, centrifugation, drying, milling, bl
Execute and supervise API manufacturing activities as per approved BMRs, SOPs, process parameters, and production plans. Operate and monitor process equipment, including reactors, centrifuges, filter
Process Development: • Conduct laboratory experiments & trials to modify processes develop shorter processes to reduce present cost. • Send sample to QC of studied experiment. • Contact QC dept. to
Production : •To check the labels of raw material, packing materials and solvents before usage. •To maintain storage conditions of raw material/intermediates in plant. •To maintain process conditions
Plan, execute, and monitor solvent recovery operations as per production schedules and approved SOPs. Supervise the recovery, purification, and segregation of solvents generated during API manufactur
Execute manufacturing activities for API intermediates and finished active pharmaceutical ingredients as per approved Batch Manufacturing Records (BMRs), SOPs, and production plans. Operate and monit
1. Ensure the cGMP compliance of packing area Key Responsibilities: • Follow up of Standard operating procedure. • Follow up of Current Good Manufacturing Practices. • Completion of Online Doc
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