Vinaya Gharat
Analytical and quality-focused pharmaceutical professional
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About
Analytical and quality-focused pharmaceutical professional with 12+ years of experience in R&D (Analytical Development), Quality Control (QC), and Quality Assurance (QA) within US-FDA, MHRA, and WHO-GMP compliant environments. Proven expertise in New Product Introduction (NPI), technology transfer, and product evaluation, with strong capabilities in GMP compliance, quality risk management, regulatory coordination, and end-to-end product lifecycle management.
Experience
Sr. Executive – Quality Assurance - Mancare Pharmaceutical Pvt. Ltd.
(2025-12)
- Performed technical risk assessment and feasibility evaluation for new product introduction.
- Managed change control systems ensuring GMP compliance.
- Reviewed deviations, OOS, OOT, CAPA, complaints, and product recalls with root cause analysis.
- Ensured closure of audit observations and regulatory compliance.
- Reviewed qualification protocols and reports (IQ/OQ/PQ).
- Reviewed Site Master File, SOPs, and Quality Risk Assessments.
- Conducted team training and capability development.
R&D (Analytical Development) - IPCA Laboratories Ltd.
(2015-04 - 2022-05)
- End-to-end New Product Introduction (NPI) including feasibility evaluation and risk assessment.
- Managed Product Technology Transfer (PTT) and documentation.
- Prepared and reviewed NPI documents including API and packaging details.
- Coordinated with Regulatory Affairs for approvals and dossier submission.
- Ensured analytical readiness via method validation and transfer.
- Supported scale-up, equipment qualification, and process validation.
- Handled lifecycle stages including EB batches and commercialization.
- Developed STPs and conducted stability studies.
- Managed change control and OOS/OOT investigations.
QA/QC - Lupin Ltd.
(2010-04 - 2015-04)
- Ensured GMP/GLP compliance and supported audits.
- Managed deviations, CAPA, and documentation.
- Performed QC analysis using HPLC, FTIR, UV instruments.
Education
PG Diploma - Analytical Techniques - University of Mumbai
B.Sc. - Chemistry - University of Mumbai
