Experience

Bruck Pharma Pvt. Ltd

• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• General Manager (Operations)

  • Jul 2022 - Present

  ~ 𝙎𝙥𝙚𝙖𝙧𝙝𝙚𝙖𝙙𝙚𝙙 6-8 𝙞𝙣𝙨𝙩𝙖𝙡𝙡𝙖𝙩𝙞𝙤𝙣/𝙘𝙤𝙢𝙢𝙞𝙨𝙨𝙞𝙤𝙣𝙞𝙣𝙜 𝙥𝙧𝙤𝙟𝙚𝙘𝙩𝙨 𝙤𝙛 𝙣𝙚𝙬 𝙛𝙖𝙘𝙞𝙡𝙞𝙩𝙮 𝙚𝙨𝙩𝙖𝙗𝙡𝙞𝙨𝙝𝙢𝙚𝙣𝙩𝙨 𝙖𝙣𝙙 𝙢𝙤𝙙𝙞𝙛𝙞𝙘𝙖𝙩𝙞𝙤𝙣𝙨 ~ As Senior Manager, I am responsible for monitoring day-to-day activities of the unit with proper utilization of manpower while ensuring production targets are achieved. 𝐑𝐨𝐥𝐞𝐬 𝐚𝐧𝐝 𝐑𝐞𝐬𝐩𝐨𝐧𝐬𝐢𝐛𝐢𝐥𝐢𝐭𝐢𝐞𝐬 • Execute and commercialize ANDA: Isotretinoin, Doxercaciferol, Dutasteride capsules for USA, Europe, Canada, Spain • Build a culture for “Right at First Time” with aim for zero error and ensure facility is always ready for audits. • Investigate deviations in products from the specifications as well as implement corrective/preventive action and its tracking for close out for tablets, capsules, and pellets. • Monitor change controls to meet the FDA regulations; perform internal and external audits within stipulated timeline. • Analyze and calculate procurement costs and develop cost reduction strategies along with driving purchasing decisions based on cost and scenario analysis, and market trends. • Perform investigation of complaints, OOS, OOT along with implementation of new project like SAP, CIPDOX FOR QMS, TRACKWISE for QMS, SCADA, PRANAAM (e-Log). • Monitor, interpret, and assess developments in guidance, regulations, practices, and policies in CMC /GMP and OPEX /CAPEX areas along with training juniors. 𝐈𝐧𝐝𝐮𝐬𝐭𝐫𝐢𝐚𝐥 𝐕𝐢𝐬𝐢𝐭𝐬 • Visited Prosys Innovative Equipment Web City, Joplin Missouri, USA for FAT of Syringe Filling Machine in 2012 • Went on-site to the US in 2016 for auditing following vendors: Genesis Industries, Multisorb Technology, Amcor Rigid Plastic, Becton Dickinson, and Meggle (Devisco Food International) 𝐇𝐢𝐠𝐡𝐥𝐢𝐠𝐡𝐭𝐬 • Got the facility approved by USA, MHRA, TGA, APVMA Australia and WHO. • Gained approval as Technically Qualified Staff in Oral Paste Manufacturing and Suppository Manufacturing by FDA Maharashtra. Show less



Strides

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Production Manager

  • Dec 2004 - Mar 2005

  As Production Manager at Strides Arcolab Limited, I executed production plan as per requirement for soft gelatin capsules and reviewed batch documents. I developed and oversaw schedules, production requirements, and headcount to determine cost effective and efficient production methods while ensuring improved performance in quality, cost, delivery, safety, and morale. I also established creative manufacturing solutions and SOPs as well as took an active leadership role in development and implementation of continuous process improvement tools. Show less



Cipla

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Management Staff

  • 1996 - 2004

  ~ 𝙎𝙥𝙚𝙖𝙧𝙝𝙚𝙖𝙙𝙚𝙙 5-6 𝙞𝙣𝙨𝙩𝙖𝙡𝙡𝙖𝙩𝙞𝙤𝙣 𝙖𝙣𝙙 𝙘𝙤𝙢𝙢𝙞𝙨𝙨𝙞𝙤𝙣𝙞𝙣𝙜 𝙥𝙧𝙤𝙟𝙚𝙘𝙩𝙨 𝙤𝙛 𝙣𝙚𝙬 𝙛𝙖𝙘𝙞𝙡𝙞𝙩𝙮 𝙚𝙨𝙩𝙖𝙗𝙡𝙞𝙨𝙝𝙢𝙚𝙣𝙩𝙨 𝙖𝙣𝙙 𝙢𝙤𝙙𝙞𝙛𝙞𝙘𝙖𝙩𝙞𝙤𝙣𝙨 ~ As Management Staff, I reviewed production schedule, studied and clarified specifications, calculated requirements, and assembled and weighed materials and supplies. I made sure of compliance with the health, safety, and environment standards as well as OPEX and CAPEX as well as worked towards minimizing the documentation error and controlled cost through yield improvement and cycle-time reduction. Moreover, I assisted with new product development and launches as well as with audit and its implementation. I supported manufacturing operations with quality assurance practices along with planning and coordinating daily shop floor activities and managing the staff. I also maintained safe and clean work environment by following cGMP, and standard operating procedures, complied with legal regulations, and monitored environment. 𝐇𝐢𝐠𝐡𝐥𝐢𝐠𝐡𝐭𝐬 • Led installation and commissioning of hard gelatin and soft gelatin capsules at Kurkumbh and Goa. • Approved as technically qualified staff in Sterile Product Manufacturing (Ophthalmic Ointment) by FDA Maharashtra. Show less



Lupin Laboratories Limited

• India
• Consumer Services
• 1 - 100 Employee

• Production Officer

  • 1994 - 1996



Wokhardt Limited

• India
• Appliances, Electrical, and Electronics Manufacturing
• 1 - 100 Employee

• Pharmacist

  • 1990 - 1994

  𝐇𝐢𝐠𝐡𝐥𝐢𝐠𝐡𝐭𝐬 • Modified blister pack line to reduce foot print. • Gained approval as a Technically Qualified Staff in Capsule Manufacturing by FDA Maharashtra. 𝐇𝐢𝐠𝐡𝐥𝐢𝐠𝐡𝐭𝐬 • Modified blister pack line to reduce foot print. • Gained approval as a Technically Qualified Staff in Capsule Manufacturing by FDA Maharashtra.