Bhupesh V

Result-oriented Senior Quality Management Professional with 14+ years of experience in QA & QC across product ranges like OTC, Herbal Products, Food, Cosmetics & FMCG. Expert in TPM/CMO Quality management, Audits, QMS, and NPD. Proven track record of improving compliance, reducing quality issues and driving process excellence. 10+ year experience in handling & calibration of precise analytical instruments (HPLC, AAS, HPTLC, UV-Spectrophotometer etc.) & LIMS, Method Validation.

SR. Executive CQA at Sapat Global Health Pvt Ltd. (2016-01 – Present)

Managing quality for multiple TPM/CMO sites ensuring 100% compliance with HACCP, cGMP, GLP & technology transfer for NPD. Responsible for QMS quality planning, method validation, stability studies, vendor qualification, audits, and market complaint handling.

• Managing quality for multiple TPM/CMO sites ensuring 100% compliance with HACCP, cGMP, GLP & technology transfer for NPD (New product development)
• Setup new method development processes validation protocol /specifications & SOP's documentation preparation for NPD as per ISO 9001:2015 guidelines
• Monitoring stability study & documentation for NPD (New product development)
• Quality Management System (QMS) quality planning and quality improvement activities using 7 basic quality control tools for process control & quality improvement
• Preparation of APQR documents of suppliers vendor qualification (eg. RM & PM)
• Handling market complaints, Conduct plants audits, Review change control / Deviations / OOS / OOT / CAPA and APQR (Annual Product Quality Review)
• Co-ordination with NABL approved drug testing laboratories for analysis of products
• Review and preparation of BMR, BPR, MFR, (Specification of RM, PM, FP), Stability data etc.
• Panning and conducting the audit for existing & new suppliers, TPM / CMO's
• Prioritize audits based on quality risk, product criticality, and supplier performance history
• Evaluate suppliers, TPM / CMO's - Manufacturing capability, QMS, Infrastructure readiness & regulatory compliance, verify quality checkpoints in production, filling, dispatch & QC
• Conduct pre-qualification audits & assess supplier / vendors capabilities across infrastructure, manufacturing processes, quality systems & documentation practices
• Review visual inspection processes, seals integrity, leakage test & batch traceability system
• Recommend supplier approval or rejection based on audit outcomes
• Conducting Audits of TPM, Depots and C&F handling Raw, Finish & Packaging material
• Assess temperature & humidity control, storage conditions, stacking practices
• Ensure compliance with FIFO inventory management practices and traceability system
• Responsible for review and evaluation of CAPA , Change controls & Deviations
• Providing training to TPM / CMO's sites for HACCP, cGMP, GLP, IPQA
• Responsible to identify, evaluate & report quality risk levels associated with the TPM / CMO's & effective implementation of the mitigation plan as per identified risk
• Preliminary Assessment & Categorization of complaints categorized based on severity (Critical, Major, Minor)
• Responsible for complaint Receipt, Review, Investigation, Evaluate & Closing of complaint

QC Analyst at SITEC LABS Ltd. (CIPLA) (2008-05 – 2016-01)

Conducted finished products, raw materials and packaging material analysis. Worked as core instrumentation team member handling multiple analytical instruments including HPLC, AAS, UV-Spectrophotometer, HPTLC, and other laboratory equipment.

• Finished Products Analysis as per FG specifications
• Raw Material analysis as per RM specifications (as per IP, BP & USP )
• Packaging material Analysis as per specifications
• Worked as a Core Instrumentation Team on HPLC, AAS, UV - Spectrophotometer (Double & Single Beam)
• Potentiometer, Karl Fischer Auto Titrator
• HPTLC (Herbal Products Analysis), FTIR , Dissolution, DT, Friability & Hardness Tester
• pH - Meter , Refractometer, Viscometer, Melting Point Apparatus

QC ANALYST at SHANGRILA FOOD PRODUCTS (Britannia LTD) (2008-01 – 2008-05)

Quality Control department for Britannia Biscuit Manufacturing. Performed analysis of finished goods, raw materials and packaging materials with documentation.

• Britannia Biscuit Manufacturing in Mumbai
• Analysis of Biscuits FG, RM & Documentation
• Sampling of FG, RM & PM for analysis
• Online Quality Checks (IPQA)
• Stock checking

Trainee Chemist at MERIND LTD. (WOCKHARDT ENTERPRISE) (2007-01 – 2007-06)

QA & QC department trainee. Performed analysis of APIs, raw materials and documentation.

• Analysis of API's , RM & Documentation

MBA in Operational Management – ICFAI University (2015)

B.Sc in Chemistry – Kirti College, Mumbai University (2006)

HSC in PCMB – Kirti College, Mumbai University (2002)