Pharma production api jobs in Diu

 ...Plant Details : USFDA Formulation Manufacturing Plant based at Daman near Vapi (Gujarat). Position : Manager - Production QMS (Sterile) Position Reports to : Senior Manager -Production(Sterile) Desired Qualification : / Job Description: 1. Change control/ Deviations... 

 ...Sterile Manufacturing Operations: Oversee aseptic filling compounding filtration and lyophilization processes to ensure product sterility and quality. Aseptic Practices & Compliance: Ensure adherence to GMP USFDA MHRA WHO and EU-GMP guidelines maintaining sterility... 

 ...Production Planning & Execution: Oversee the daily production schedule for GranulationCompressionand Coating to ensure timely delivery of batches as per the Monthly Production Plan . BMR/BPR Review & Data Integrity: Perform a thorough technical review of Batch Manufacturing... 

 ...protocols ensuring all tools used are sterilized/autoclaved before entry. Lubrication & Spare Management: Ensure the use of Food-Grade/Pharma-Grade lubricants for all moving parts and maintain a critical spares inventory to reduce Mean Time to Repair (MTTR). Logbook... 

 ...punches and dies under technical supervision. Lubrication & Upkeep: Execute systematic greasing and oiling of machine parts using pharma-grade lubricants to ensure smooth operation. Documentation Learning: Maintain equipment logbooks and assist in updating equipment... 

 ...electrical components of Air Handling Units (AHUs) chillersand cooling towers to maintain precise temperature and pressure differentials in production areas. Preventive Maintenance (PM): Execute the PM schedule for all utility equipmentincluding motor control centers (MCC)VFDs (... 

The Senior Officer QC (Validation) will be responsible for testing and analysis of sample to ensure compliance . Perform validation activities for QC instruments equipment and analytical methods as per regulatory guidelines (USFDA EU ICH). Execute calibration qualification...

 ...Checks: Execute and supervise physical checks (e.g. weight variation friability disintegration leak tests for blisters) to ensure the product meets specifications during the run. Sampling: Manage the collection of in-process samples blend samples stability samples and... 

System Design & Optimization: Oversee the operation of Air Handling Units (AHUs) Chillers and Cooling Towers. Optimize airflow patterns and pressure cascades to prevent cross-contamination between different processing zones. Validation & Qualification: Lead the Re-qualification...