Nishant Sharma
Manager Qc @Cadchem Laboratories Ltd
Signup · Get unlimited contacts
WORK HISTORY
Manager Qc @Cadchem Laboratories Ltd
Chandigarh, IN
Laboratory ManagementSupervise testing of raw materials, intermediates, APIs, and stability samples.Ensure adherence to specifications outlined in Pharmacopeias (USP, EP, BP, IP) or customer requirements.Maintain an efficient workflow to meet production timelines.2. Compliance & Regulatory AdherenceEnsure QC operations comply with ICH Q7, GMP, GLP, USFDA, EU-GMP, WHO, and other global regulations.Prepare for and support regulatory audits (USFDA, EDQM, WHO, etc.) and customer inspections.Handle OOS, OOT, LIR, and deviation investigations in compliance with regulatory requirements.3. Documentation & Data IntegrityReview and approve analytical test reports, COAs, SOPs, and method validation reports.Ensure data integrity (ALCOA+ principles) across all QC activities.4. Instrumentation & Analytical TechniquesOversee qualification, calibration, and maintenance of analytical instruments:Chromatographic methods: HPLC, GC (for solvent residual analysis).Spectroscopy: UV-Vis, FTIR5. Stability Studies & Method ValidationOversee ICH Q1 stability studies for APIs under various storage conditions.Ensure method validation, verification, and transfer as per ICH Q2 (R1) guidelines.Manage impurity profiling, genotoxic impurity assessments, and residual solvent testing.6. Investigation & CAPA ImplementationLead laboratory investigations for non-conformances, impurities, or unexpected analytical results.Implement CAPA to address recurring QC issues.Collaborate with QA for impact assessment and risk mitigation.7. Team Management & TrainingTrain and mentor analysts on HPLC, GC, wet chemistry, and regulatory compliance.Ensure continuous development of QC personnel through workshops and training programs.8. Coordination with Other DepartmentsWork closely with:QA for batch release and compliance activities.Production to resolve in-process quality issues.R&D & ADL for method transfer and validation.
EDUCATION
Hemwati Nandan Bahuguna Garhwal University
Master's Degree, Organic Chemistry
SKILLS
ABOUT NISHANT SHARMA
Experienced Quality Professional with about 14 years of expertise in Quality & CSV within leading pharmaceutical organizations. Skilled in implementing GMP standards, conducting audits, and driving process improvements to achieve operational excellence. Certified ISO 9001:2015, ISO 14001:2015, & ISO 19011 Lead Auditor and Lean Six Sigma Practitioner, with a proven ability to manage investigations, root cause analysis, and risk mitigation strategies. Passionate about fostering a culture of quality and continuous improvement, ensuring compliance with global regulatory standards, and contributing to organizational growth. Currently seeking opportunities to leverage my expertise in Quality Specialist or leadership roles in the pharmaceutical industry.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.