Manager - Production GI ( Injectable )

Role & responsibilities

 Ensure Day to Day planning and execution for target achieving of Monthly production plan.

•  Proper co-ordination and communication with other departments for better execution of processes.
•  Preparation and Review of Machine URS/DQ/IQ/OQ/PQ protocol and execution of qualification activities.
•  Preparation and review of SOPs, BMR/BPCR, BPR.
•  Handling batch activities for new product/pack presentation introduction like Media fill, Scale-up/engineering, Exhibit, PPQ (Process performance qualification, Process validation) and commercial batches.
•  Ensure the completion of batch as per the production plan and control on daily production output.
•  Review and compliance of executed batch records and timely submission to QA.
•  Ensure online documentation with 99% RFT.
•  Immediate information to superior in case of finding of any anomalies in process/batch.
•  Optimization of Man-Machine utilization to achieve pre-set production targets.
•  Active involvement in inspections preparation and maintain department Ready for Inspection.
•  Any other assignments allocated by superiors.
•  Must have knowledge and active involvement in QMS for production related queries/Observations/Improvement drives/Responses.
•  Proper and adequate upkeep of area and equipments.

Skill & Qualification:-

•  Minimum B. Pharm and M. Pharm
•  Minimum 12 to 18 years of relevant experience required
•  Production Planning, Aseptic Area, Batch Processing, Manufacturing, SAP
• QMS Compliance, Clean Area, GMP, GDP, Regulatory Knowledge, BMR, BPR, NVPC and Documentation, MIS