Suresh Kumar

About Suresh Kumar

Open to Work#Looking for New Opportunities With 22 years of relevant experience in the pharma, i came with background of Master of Science (M.Sc.) organic Chemistry.Last position served as DGM QC, and now looking for new Opportunities. I define myself as an SME in Analytical Quality Control & Stability, well-versed with end to end scope of laboratory operations, starting from planning to release of COAs to Quality Control & Assurance.In my past career worked across laboratory areas/sections, where I was experienced in handling GLP/Complex instrumentation such as Cinematographic Technics (HPLC, GC, UPLC, etc.), Disso, their software\'s i.e. empower, Chromeleon, LIMS, expert in setting up new labs, remediations etc. Expert in handling OOS Investigations, lab Incidents, conflict, client and Stakeholder management, working among cross-functional teams.Expert in Audit management, and have participated in many regulatory Audits to sustain the regulatory approvals.Worked with MNCs on different roles in Laboratory Operations, as a people manager, have managed the team size of 150- 200 ( direct reporties 15)

Experience

1. Deputy General Manager

   Zim Laboratories Limited Nagpur

   May 2025 — Present

   Key Responsibilities:People Development & Succession Planning:Drive continuous professional development, cross-functional training, and knowledge sharing. Ensure robust succession planning with trained backups for all critical laboratory roles.Regulatory Compliance & Laboratory Governance:Oversee all activities to ensure laboratory operations meet regulatory standards (e.g, USFDA, MHRA, WHO, EMA). Ensure audit readiness at all times and lead the timely closure of audit observations through CAPA implementation and effectiveness checks.Stability Program Management:Manage the timely execution of stability studies and the accurate generation of summary reports in line with ICH guidelines.Quality Oversight & Documentation Control:Conduct periodic reviews of QC Documentation. Ensure adherence to ALCOA+ principles for data integrity.Timely Release & Product Lifecycle Support:Ensure the on-time release of Certificates of Analysis (CoAs) for raw materials, in-process materials, finished products, packaging materials, and stability samples, supporting seamless product supply.Contract Laboratory Management:Manage execution of Technical Quality Agreements (TQAs), the qualification of vendors, and sample testing aligned with regulatory and quality standards.Analytical Method Lifecycle Management:Lead planning and execution of AMT and Analytical Method Validation (AMV) projects in compliance with ICH Q2/Q14 guidelines.Regulatory Submission & Query Response:Provide robust technical support for regulatory submissions and timely responses to agency queries during product registration and inspection.Quality Risk Management (QRM):Conduct structured QRAs for laboratory operations using tools like FMEA and risk ranking, ensuring control strategies are scientifically justified and implemented.Digitalisation & Continuous Improvement:Support digital LIMS, CDS, ELN, drive lean lab practices (e.g, 5S, Kaizen) to enhance efficiency and reduce errors.

Education

• Public Inter College Jauligarh

  CCSU MEERUT, Chemistry