DILLI BABU S

Seeking suitable position and dynamic, progressive development in Pharmaceutical Industry, where apply my talent and enthusiasm also have great deal of experience, abilities in the Manufacturing, Quality Management system and other bench marking activities under the pharmaceutical cGMP environment, to make the best for growth and success of the Organization thereby enhancing my professional advancement and learn new technologies as well.

• Ontime completion of all the PV Activities for every six months.
• Successfully ran 3 consecutive media fills after a long shutdown
• Successfully launched ERTAPENEM FOR INJECTION 1gram project with our team.
• Successfully completed Clinical trials of INSULIN GLARGINE,INSULIN 30/70,INSULIN R & INSULIN N PRODUCTS
• Successfully launched ENOXAPARIN SODIUM INJECTIONS IN 0.4ML,0.6ML IN PREFILLABLE SYRINGES & 3ML CARTRIDGES.
• Successfully completed the TT&PV Of TERIPARATIDE (r-DNA) INJECTION
• Successfully completed the TT&PV Of LIRAGLUTIDE FOR INJECTION(r-DNA ORIGIN)

• Well exposures of sterile formulation Equipment, handling of shift responsibilities and Production process and document related activities.
• Experience in Batch Process of Sterile manufacturing activities and Reconciliation.
• Knowledge of raw materials, production processes, costs, and other techniques for maximizing the effective manufacture and distribution of goods.
• Involved Critical Process Equipment Validation (IQ, OQ, PQ) and Requalification (RQ).
• Follow and execute the operation goals for shift basis activities
• Coordinating with Cross functional team to get work done.
• Meeting the production schedule adherence by remove the road blocks during operations with compliances. Reduce the changeover timing to meet the schedule adherence.

• Following of Safety Instructions, cGMP, Personnel Hygiene, Gowning Procedure, cleanroom behaviors, Standard Operating procedure, standard cleaning and Operating Instructions and Guide lines.
• Verify the Dispensed Raw materials, Primary packing materials (PPM), Secondary packing material (SPM) with respect to MML (Manufacturing Material List) mentioned in the batch record.
• Supporting to In-process QA for Line and Equipment Clearance prior to start the batch Manufacturing and other activities.
• Handling, Executing and verifying the critical process equipment’s Operations, monitoring and in-process checks, and periodic verification/ requalification, calibration, maintenance/preventive maintenance of all the manufacturing processes equipment’s at all stages.
• Online documentation and good Documentation Practices (GDP) in Batch Manufacturing Record (BMR), Media Fill batch Record (MBR), Log books and register and other documents circulated in the shop floor.
• Preparation of Batch Records, SOPS.
• Trending the Production data.
• Co-ordinate internal Audit and complete the raised concern during self-Inspection.
• Calibration of Weighing balances and keeps the equipment’s in calibrated state.
• Minimizing the commonly occurring problems during Operations
• Optimizing the process with minimum time and maximum process yield.
• Co-Ordinate with team to get work complete with compliance manner.

• Regenix Biosciences Limited:
• PHARMAVALID Steam sterilizer
• LP PHARMA Combi ( Vial, Cartridges and PFS) Filling and stoppering machine.
• Dyna Biotech Bulk preparation and Formulation Vessel/reactors(50L).
• METONE Particle Counters
• MDI Filter Integrity Testers
• Vacuum leak test apparatus for sealed vials
• ELMACH Blister Pack Machine
• Pfizer Healthcare India Private Ltd. Chennai & Hospira healthcare India Private Limited.
• FEDEGRAI Autoclave (Moisture (Steam) heat Sterilization)
• IMA Vial washing machine (External & Linear)
• IMA Vial Sterilization tunnel (Dry Heat Sterilization)
• IMA EXTREMA F2000 Vial Filling and Stoppering Machine (Dry powder & Liquid Injection)
• IMA vial sealing machine
• METONE Particle counters
• Sartorius and Millipore Filter integrity test apparatus (BPT, WIT, etc..)
• Vacuum leak test apparatus for sealed vials.
• Light house Online Particle monitoring Systems.

• Father’s Name : V. Subramani
• Date of Birth : 1993-08-19
• Gender : Male.
• Nationality : Indian
• Religion : Hindu
• Marital status : Single.
• Language known : Tamil, English.
• Willing to relocate : Yes