Skills

• Accomplished professional with over 6+ years of experience relating to Quality Assurance, validation and Quality Management System.
• Currently with M/S Shantha Biotechnics Private Limited (A Sanofi Company), as senior officer – QA Validations and Packing operations. Managing QA & Validation activities of Vaccine section.
• Worked with M/s Mylan Laboratories, as senior officer QA & Quality Management System, handled change controls, corrective & preventive actions, incident management and Quality Risk Management.
• Worked with M/s Cipla Ltd, as Management staff QA & Validations, handled various validation, commissioning and qualification projects for FFS and Liquid oral manufacturing and filling suites.
• Worked with M/s Gland Pharma Ltd, as Trainee chemist QA & Validations in Green fields Projects QA for for vial line III & IV.
• In depth expertise in preparing various protocols for Process validation, Equipment qualification-IQ, OQ, PQ (Liquids, Injections, Form Fill Seal & Vaccines) in compliance to QA regulatory requirements in manufacturing and qualification prospective.
• Successfully handled external audits from international agencies like MHRA, USFDA, TGA, ANVISA, CDSCO and WHO approvals for manufacturing.
• Aware of regulatory and guidelines requirements like, ISPE, 21 CFR Part 11, GAMP-5, USFDA, EU, ASME BPE.
• Successfully handled process improvement projects relating to facility, equipment and plant implementing modifications to optimize utilization of resources, minimize contamination and maintain in process quality systems.

Refrences

• Achievements at Shantha

• Successfully handled audits from Global and local regulators (France, DCGA and CDSCO).
• Successfully completed the conventional filling machine upgradation with RABS projects for B S.
• Received appreciation “WOW” cards for excellent performance and identification gaps across the site.
• By delivering within the specified timelines with no compromise in quality, successfully increased the orders from clients.
• Provided the Data Integrity awareness to shop floor personnel’s and contributed Data Integrity poster in DI EDGE forum to create the data integrity awareness overall the site.

• Achievements at Mylan

• Successfully handled audits from National and international regulatory authorities (USFDA, TGA, MHRA, ANVISA, WHO and CDSCO).
• Successfully completed the suite-III project for upgradation of filling machine, sealing machine and autoclaves.
• Appreciated for revision of the existing risk management procedure to incorporate the risk management tools and risk register.
• Based on performance, got a high satisfaction rating from the organization.

• Achievements at Cipla

• Successfully faced audits from international regulatory authorities and customer (USFDA, TGA, Santen oy, Malawi, Zimbabwe and Kenya).
• Succeeded in qualifying entire Form Fill Seal and Liquid oral section equipment and facility in a short time
• Introduced

Time and Spatial Flexiblity

Ready to relocate and ready to travel 40 hours per month.

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