Shrikant Sharma
Senior Manager- Tpm Pqa @AbbVie
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WORK HISTORY
Senior Manager- Tpm Pqa @AbbVie
Ludwigshafen, DE
EDUCATION
Sam Higginbottom University of Agriculture, Technology And Sciences (SHUATS)
Engineering, Biotechnology
ABOUT SHRIKANT SHARMA
Dynamic and Competitive ’Quality and Operation management‘ professional having around 16+years of experience in Pharmaceuticals Quality assurance and cGMP. Extensive range of experience from Quality, Operations Management, Project management, Auditing (cGMP), Process Validation, Handling Deviations, Change controls and Market complaints, Handling OOS (out of specification) and OOT (out of trend), Validation & Qualification, Technology Transfer, Lean/ Six Sigma, Quality Risk Management and Handling of CMOs (Third party management/ external manufacturers).Understand the scientific principles required for manufacturing products in area of influence (PAR or DAP) including the interaction of the chemistry, equipment, components, aseptic processes, and container closure systems.Support Site Leadership in areas of device assembly and packaging.Participate in the development and implementation of strategies associated with the area sponsoring or supporting the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), and Failure Modes Effect Analysis (FMEA).Support site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections.Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc.Work cross-functionally with the area process teams for metrics reviews, operational support, and issue / deviation management.Drive control, capability, productivity, and continuous improvement for the process.Support and/or lead technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity.Serve as technical interface external to the site.Work within or lead multi-functional teams in positive fashion to implement objectives and deliver on business plan and quality objectives.Network and collaborate with global and other parenteral sites to understand best practices, share knowledge, and participate in tactical and strategic business planning.Ensure a safe working environment through compliance with safety rules and improving safety culture by actively participating in safety-related activities.
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