Vanita Bhad

Quality Manager with 26.6 years [18.6 yrs.’. Pharma API manufacturing 50 API psychotropic for export as per 07 international standards & 8 yrs.’ Dyes.] of experience in building robust Quality system to meet customer & regulatory requirements. Expertize in implementation of GMP/GLP as per ICH & Regulatory guidelines, CAPA & New Vendor Approval.

Assistant Manager Quality Control. - CENTAUR PHARMACEUTICLAS PVT. LTD. (API DIVISION) - Ambernath

(2004-06 - 2023-01)

Responsible for managing Quality Control system & GMP as per regulatory guidelines.

• Managed Q.C. team of 12 members to smoothly conduct all Q.C. activities, including shifts with strict adherence to procedures & monitor key performance indicators.
• Inspection - 400 type’s raw material, 200 types intermediate & 60 types of finished products.
• Conduct planning to review analytical data prior to batch release for Raw Material, Packaging Material, Semi-Finished Product, In-process, Finished products, Stability and water samples.
• Handled customer & regulatory inspections & audits.
• Handled customer queries & complaints, investigate root cause & initiate CAPA.
• Prepare, update, review & maintain Test procedures and SOP’s as per regulatory guidelines.
• Review, approve & maintain protocols and Reports Analytical method transfer, verification, validation, feasibility equivalency and other documents as per QMS.
• Initiate change control for Pharmacopoeia changes and risk assessment.
• Approving all changes that affect intermediate & API Quality.
• Review & verify documents, update in computerized system.
• Initiate CAPA, conduct root cause analysis, Implement actions, approval of Change Controls, Deviations, Laboratory Incident, OOS and OOT Investigations & effective CAPA closure.
• Conduct trainings to team on GMP & data integrity and Qualify team, based on evaluation report.
• Conduct periodic & random audits to ensure compliance with Good Laboratory Practices.
• Supplier improvement – Analysis of samples, approval, qualification, rating & approve supplier.
• Periodic data collection, analysis, feedback to MIS, maintain analysis data with backup.
• Conduct sampling activity and maintain control samples, Storage condition, retrieval and retention & monitor expiry dates.
• Responsible to maintain EHS objectives & Quality targets including, internal defect rate, safety & hazards, internal rejections, Environmental risk.
• Plan & execute budget, equipment’s, resources, tools & manpower resources.
• Use effective system for Instruments Qualification, calibration & preventive maintenance.

Quality Control Chemist - SABARI DYE CHEM INDUSTRIES PVT. LTD. - Ambernath, Dist. Thane

(1996-07 - 2004-06)

Successful Management and Quality Control of the laboratory for over eight years.

• Perform the analysis of incoming raw material and finished Products.
• In process testing for reaction monitoring.
• Performed experimental batches in lab to carry out commercial batches.
• Testing of material by titrations, TLC, Printing, Dying, colour fixation.
• Processing cotton for testing reactive dyes.
• Matching the shades required to customer (NOVA SCAN software) by mixing the colours.
• Prepared the shade cards for marketing.

B.Sc. - Chemistry - R.K. Talreja College, Ulhasnagar, Mumbai University (1996-06)

Diploma - Office Automation & Financial Accounting - CDAC