Karthik B

Seeking a senior position in the Pharmaceutical projects which focusing on Project for Suspension, Emulsion Products, FAT, DQ, SAT, IQ, OQ, SOP, PQ Of Filling Isolator and Manufacturing Equipment

• Alembic Pharmacuticals Private Limited, Vadodara, Gujarat, INDIA, Jr EXECUTIVE - 2, 06/2018, Present, Review and Execution of CSV, IQ, OQ, Development Cycles of Process Equipment's Such as Filling Machine, Leak Test Apparatus, Fedegari Autoclave, Dynamic Cup board and Pass box, Manufacturing Tanks, Bio-Decontamination Chamber.., Inventory Control and Mangement, Procurement of Consumables and Primary Packing Materials related to the Filling & Compounding Process., Consumable Code Creation in SAP for the New Materials which is required for Process., Knowledge in Operation & Maintenance of Robotic Syringe Filling Machine - SFM., Knowledge in Process and Operation of Manufacturing Tanks From DD Enterprises., Knowledge in Process and Operation of Bio-Decontamination Chamber - Pass Box., Knowledge in Process and Operation of Autoclave Steam Sterilizer From Fedegari., Knowledge in Process and Operation of Tub Transfer & Collection Unit., Control and Maintain of PPM - PFS (COP & Glass Nested Containers and Plunger Stoppers) & Cartridge (Glass Nested Containers & Plunger Stoppers) Liquid Filling., Involvement in Air Visualization Study, Area Qualification, Gowining Qualification, HEPA Filter Integrity Test, NVPC and Cleaning Validation., Maintain and Issuance of Consumables like Filters, Silione Tubings, Produt Flow Paths, Single Use Connector & VPHP Solution (H2O2).
• Mylan Laboratories Limited, Hosur, Tamil Nadu, INDIA, ASSOCIATE, 03/2016, 05/2018, Qualification of Process Equipment's Such as Filling Machine, HAWO Sealing Machine, Autoclave, Filter Integrity Test Machine, Manufacturing Equipments.., Inventory Control and Mangement, Procurement of Consumables and Primary Packing Materials related to the Filling & Compounding Process., Consumable Code Creation in SAP for the New Materials which is required for Process., QMS, CAPA & Change Control and Review through Track Wise., Knowledge in Operation of Aseptic Filling Machine with Integrated Isolator - Vanrx., Knowledge in Operation of Aseptic Dry Powder Filling Machine with Integrated Isolator - JP Machine Tools, Steris VPHP Generator & Schematic Engg., Knowledge in Process and Operation of Manufacturing Tanks From DD Enterprises., Knowledge in Process and Operation of Buchi Glauster (Reactor and Rotavapor)., Knowledge in Process and Operation of High Pressure Homogenizer From GEA & Avestin., Knowledge in Process and Operation of Top Mounted & In line Homogenizer From Kinematica., Knowledge in Process and Operation of Raw Materials dispensing Isolator from Extract Technology., Knowledge in Process and Operation of Autoclave Steam Sterilizer From Tuttnauer., Control and Maintain of PPM - Vial (6R & SiO2 Nested Containers Plunger Stoppers), PFS (COC & Glass Nested Containers Plunger Stoppers) & Cartridge (Glass Nested Containers & Plunger Stoppers)., BMR Review Based on QMS Compliance, Bulk, PPM & Yield Reconcilation., Maintain and Issuance of Consumables like Filters, Silione Tubings, Produt Flow Paths, Single Use Connector, Single Use Mobius Product Bag, Glasswares & VPHP Solution.
• PFIZER INC., Chennai, Tamil Nadu, INDIA, OFFICER, 06/2013, 03/2016, Dry powder filling injectable Small and large volume parental., With the Knowledge of Working and Supervising of Fedegari Autoclave Machine, With the Knowledge & Working & Supervision of Vial Filling & Stoppering Machine - IMA MD300, Involved in Performance verification (PV) of Filling Machine and Fedegari Autoclave., Involved in all Media Fill & Involve in Solution Filtration with operating BPT Apparatus., Monitors product quality; follows established department SOP's and batch record instructions; and prepares SOPs and batch record revisions, Involvement & Supporting of the Validation Department for completion of the Autoclave P.V Cycles within the Planned time, Participation in process simulation (Aseptic media filling)., To ensure that production operations carried out as per cGMP regulations., Continuously reviewing and revising the procedures and systems according to current GMP and regulatory requirements., To ensure Calibrations of the instruments and Validations of the equipment's carried out as per schedule., Operation Sartorius Filter Integrity Machines with WIT & Non-Viable Particle counters.

• Place of Birth: Madurai, Tamil Nadu, India
• Citizenship: Indian
• Father's Name: Mr. Balan R. K.
• Date of Birth: 06/02/93
• Gender: Male

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Yours Sincerely, Place: Vadodara, Gujarat, India