Mr G K Sharma

Technical Advisor

Successful track record for leading Regulatory Audits like US FDA, UK MHRA, MCC – South Africa, ANSM - France, TGA – Australia, ANVISA Brazil, WHO-Geneva, for Global Organizations Mylan, Lupin, Ranbaxy presently SUN, Alembic etc.

• Result oriented leader having strong track record of performance and turnaround high-paced organizations with large scale manufacturing operations, at different locations, in India having exceptional ability of managing people and built high performance culture.Proven track record of significant enhancement of operational efficiencies year on year, concurrences of Quality systems.

• Having strong and excellent soft as well technical skills to build sustainable business model, Lead Teams and drive them to achieve organizational targets with best practices. Lead and built teams to conceptualized and execute world class facilities across India. Complex Injectable project executed for Mylan in 2020, large scale fermentation-based API facilities executed for Ranbaxy and Lupin.

• Having Global exposures to lead Teams and build strategies for sustainable business, selection of molecule’s, ANDA, s launches their scale up/exhibit batches, approvals and commercialization. Excellent strength in automation, DCS based operations and IOT, implementation, simplifications of operations with major partners are Honeywell, Emmerson, Rockwell automations.

• Work across India with local and Global companies, well understand the local geographical statuaries and human requirements.Keep updating self for changes/upgradation in rules and regulation for business, as Government initiative to simply the rules for business after Covid 19 pandemic, such as PLI scheme, environmental laws for business continuity.

Consulting (Oct 2020 onward)
Consulting Pharma Industry for Process and Project Engineering and end to end solutions for Regulatory facility for Pharmaceuticals, Aseptic Processing, Medical Devices, Industrial Biotechnology, Specialty Chemicals, Agrochemicals, Food, Beverage & Nutrition, Process audit and the remediation, cGMP compliance as per WHO Geneva, FDA, EU, TGA, MHRA, scale up technologies, troubleshooting solutions, qualification and validation, energy audit, automation, utility management.

Successfully executed Soft Gelatin based greenfield project for regulated market in Dehradun and commissioned & commercialized in Mar2022.