Sushil Kumar Thakare

Client:- Catalent Global (Sept-2021 - Feb-2024)

• Managed global rollout of LabVantage 8.4 and site-specific master data deployment.
• Directed Master Data delivery from requirements analysis to solution design and development.
• Executed configuration changes based on evolving business needs and implemented complex calculation rules in LabVantage to automate processes.
• Led end-to-end project lifecycles, including planning, resource allocation, execution, and go-live across three global sites.
• Oversaw migration project from SQL LIMS to LabVantage 8.4.

Client: J&J Vision Care R&D (March 2024 - Present)

• Ensured compliance of laboratory systems with regulatory standards through effective validation strategies as CSV Lead for J&J.
• Oversaw implementation and validation of LabVantage 8.8 LIMS, integrating multiple systems for J&J Vision Care R&D Labs.
• Guided team members in task execution to boost efficiency and accountability.
• Coordinated resources across departments to achieve successful project completions.
• Engaged in Empower Migration Project for J&J R&D site

• Conducted workshops to gather requirements and convert them into Functional Requirement Specifications (FRS).
• Collaborated with IT and business sectors to align Pharma R&D processes.
• Managed multiple projects simultaneously, ensuring timely execution and efficiency.
• Executed comprehensive requirement analysis to provide proof of concept.
• Developed and integrated software solutions aligned with business needs.
• Performed system validation and verification to ensure regulatory compliance.
• Oversaw deployment, maintenance, training, and ongoing support of systems.
• Optimized systems through targeted analysis and enhancements.

• Implemented organization-wide Lean-Agile mindset and SAFe practices as Certified SAFe 5.0 Agilist.
• Integrated Enterprise-level ELN Workbook and Request Editor Application into digital platform.
• Executed iterative implementations of inventory, metrology, calibration modules, and stability module with SDMS integration.
• Configured staging, validation, and production environments for effective workbook installation.
• Resolved production server issues by coordinating with vendor on known problems.
• Served as analytical business SME and core team member of LIMS Team.

• Streamlined analytical methods for product development through application of HPLC, ion chromatography (IC), and LC-MS in conjunction with routine analytical testing.
• Conducted change analysis (CA) with comprehensive documentation and detailed entries in laboratory notebooks (LNB), adhering strictly to current Good Laboratory Practices (cGLP), and established Standard Operating Procedures (SOPs).
• Executed carryover studies for Key Starting Materials (KSM) and Raw Materials (RM) to ensure analytical integrity and compliance.

• Calibrated HPLC and various analytical instruments to ensure accuracy.
• Reviewed analytical data, AMTP, AMTR, reports, and ICH guidelines for compliance.
• Managed deviations and CAPAs to maintain quality standards.
• Executed thorough analysis of analytical data to support decision-making.

• Conducted routine analyses on HPLC, IR, and water content for quality control.
• Performed literature searches on Science Direct, Journals of Chromatography, and US/Europe Pharmacopeia.
• Facilitated analytical method transfers from ARD to manufacturing unit to ensure compliance.