Vinaya Gharat

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.

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.

PG Diploma - Analytical Techniques - University of Mumbai

B.Sc. - Chemistry - University of Mumbai