Mitesh Patel

Forward-thinking team leader skilled at operating departments efficiently to meet goals. Successful background matching employees with roles for maximum performance. Proactive and hardworking individual focused on continuous operational improvement.

• AMNEAL PHARMACEUTICALS PVT LTD, Pharmez, Ahmedabad, Acting as a Shift In-Charge. I have undergone regulatory audits and gained experience in the installation as well as commercialization of various formulations including vials, prefilled syringes (PFS), cartridges, ophthalmic products, bag filling, and microspheres. Experience with vial line liquid/suspension (MPA & Triamcinolone), PFS line (Fulvestrant), and Microsphere line (Octreotide). Planning and executing BMR issuance, dispensing of RM and PPM, batch manufacturing, preparation of machine parts, steam sterilizer loads, conducting filling operations, qualifying equipment, and performing media fills. Preparation of documents such as Standard Operating Procedures (SOP), Change Control Forms (CCF), Batch Manufacturing Records (BMR), Deviations, etc. Reviewing and ensuring compliance with BMR and routine cGMP documents. Handling Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Requalification (RQ). Training personnel to perform various activities according to standard operating procedures (SOPs).
• INTAS PHARMACEUTICALS LTD, Ahmadabad, Supervision of aseptic area activities including monitoring and handling of vial and ampoule filling, filtration, loading, and unloading. Supervision of clean area activities involving monitoring and handling of ampoule and vial washing and sterilizing tunnels, garment washing and drying, decartoning of ampoules and vials, equipment washing, steam sterilization of components and equipment, and terminal sterilization of products. Involvement in the re-qualification of various equipment such as vial and ampoule washing machines, autoclaves, and depyrogenation tunnels. Experience with regulatory audits including facing audits from agencies such as USFDA, MHRA, WHO, etc.
• SUN PHARMACEUTICAL INDUSTRIES LTD. Halol, Vadodara, Supervision of aseptic area activities, including monitoring and handling of vial, ampoule, prefilled syringe (PFS), dry powder, eye drop, and cartridge filling, filtration, and lyophilizer loading and unloading. Review of production documents such as Batch Manufacturing Records (BMR). Preparation of sections for various regulatory audits, such as USFDA, MHRA, etc. Ensuring quality assurance and controlling rejection rates. Familiarity with project work, area, and machine qualification in the new Cyto department.
• MARCK BIOSCIENCE LTD, Kheda, Supervision of filling activities and terminal sterilization. Dispensing of raw and packaging materials. Operation of machine fabric super-heated water spray sterilizers and steam sterilizers. Dispensing of raw materials and primary packaging materials.
• NIRLIFE HEALTHCARE LTD, Sachana, viramgam, Ahmedabad, Handling & Monitoring of Project work.

• Hobbies: Travelling and Listening Music
• Date of Birth: 02/01/1986
• Gender: Male
• Nationality: Indian
• Marital Status: married

• Depyrogenation tunnel
• Steam Sterilizer
• Vial and ampoule washing machine
• Filtration vessel
• Filling machine
• HVAC