Pune Biotech Executive Fill Finish Facility Mh

Job description

Job Description Execute and supervise sterile formulation and compounding activities in accordance with approved Batch Manufacturing Records (BMR) and Batch Processing Records (BPR). Plan and carry out dispensing, formulation, filtration, and material transfer activities in compliance with cGMP requirements and aseptic practices. Perform in-process checks, monitor critical process parameters, and maintain accurate, real-time documentation to ensure data integrity throughout formulation operations. Operate and monitor autoclaves for sterilization of equipment, components, garments, and materials as per approved SOPs and validated sterilization cycles. Load and unload autoclaves according to validated load patterns and review cycle parameters, printouts for compliance. Handle autoclave alarms, deviations, and cycle failures through proper investigation, documentation, and implementation of corrective and preventive actions (CAPA). Perform and supervise washing and cleaning of equipment, components, and accessories using automatic and manual washing systems as per approved procedures. Verify cleanliness status, labeling, release, and proper storage of washed items while ensuring segregation as per classified cleanroom area requirements. Conduct routine equipment checks, identify abnormalities, and coordinate with Engineering and Quality Assurance for timely troubleshooting and resolution. Co-ordination with CFT for batch planing and routine sceduled activities like PM, calibration and AMC related to assinged area. Work Experience 6–8 years (with hands-on experience in Autoclave, Formulation, and Washing Area). candidate shoud have regulatory plant experiance USFDA and EMA. Education Graduation in Pharmacy or Biotechnology Competencies