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
