G S PRABHAKARAN

Dynamic and results-driven General Manager with [Number] years of experience focused on driving revenue growth and enhancing profit margins. Proven ability to excel in high-pressure environments while effectively managing multiple projects and deadlines. A meticulous leader and strategic planner, equipped with strong managerial acumen and the ability to inspire teams to achieve organizational goals. Committed to fostering a customer-centric culture that prioritizes satisfaction and loyalty.

• FDA (Tamilnadu State) approved QC competent technical person.
• Active Member of Pharmacy council of India -Tamilnadu. Registration Number: 3551/A1.
• Member of IPGA.

• HPLC Maintenance and Trouble Shooting - Agilent and Shimadzu.
• HPLC Column Chemistry - Waters Corporation.
• OOS investigation and Resolution procedures - Lachman consultancy Inc., USA.
• Gas chromatograph an overview - Perkin Elmer.
• Participated in various workshops like cGLP, Analytical Competency, Leadership Skills etc.

• During working with various leading Pharmaceuticals, handled various Quality control functions and gained the experience but not limited to below:
• Key functional Areas:
• Responsible for releasing of Finished Active Pharmaceutical Ingredients and Formulations as per the proposed time line and Plan.
• Monitoring the Stability schedule and Execution of Stability analysis in Quality Control.
• Responsible for conducting Analytical method transfers from Analytical development lab to Quality control and maintaining the relevant data's.
• Responsible for Online review and approval of electronically printed data through various controls.
• Responsible for timely close out of Chromatographic deviations and Analytical deviations through ‘Incident Report / Laboratory Error report'.
• Responsible for periodic review of Log book software for all analytical instruments, Analytical Test Reports, Certificate of Analysis, Validation reports, Test data sheets and Audit trails.
• Responsible for timely completion of calibration / Performance verification of all instruments and execution of impact assessment studies if any calibration failure.
• Responsible for coordination of executing Validation and Calibration schedule of Newtronic Stability chambers and maintaining its relevant data's.
• Recording and monitoring the investigation of Out Of Specifications, Out Of Trends, Deviations and guiding for the preparation of Standard Operating Procedures for new instruments as per manual.
• Support to the troubleshooting in sophisticated analytical Instruments like HPLC, GC, UV-Visible Spectrophotometer, IR Spectrophotometer and Autotitrators etc., and maintaining its data's.
• Responsible for the compliance of major quality audits like USFDA, TGA, MHRA and ANVISA.
• Ensuring the competency of the analyst through RFT and providing Internal and External training in Relevant functional areas as per proposed time schedule.
• Gap analysis of Quality Management System in QC and ensuring continuous improvement in cGLP.
• Monitoring and Maintenance of HPLC/GC column stock, Spares and accessories and preparing Annual maintenance Contract approval forms for Instruments as per the schedule.
• Documentation Management:
• Implementation & Control of document management system in Quality control to in line with current Regulatory requirements.
• Corrective Action and Preventive Action (CAPA) Management:
• Review, Execution and Approval of CAPA management system in Quality control.
• Effective implementation, tracking and timely closure of CAPA in Quality control.
• Administrative:
• Preparing Annual budget for Quality Control lab and Continuous monitoring for cost reduction.
• Approval of purchase orders, Quotations and Indents.
• Manpower planning for Q.C Dept. and selection through competent technical interview.
• Audits Coordinated as Analyst / Handled as HOD:
• In Shasun, successfully associated with QA for MHRA (The Medicines and Healthcare products Regulatory Agency) & EDQM (European Directorate for the Quality of Medicines) inspection on 2nd & 3rd October 2003 without any major observations. (Inspected by Mr. Oliver Gross – French Agency for the Safety of Health Products and Ms. Bronwyn Phillips - The Medicines and Healthcare products Regulatory Agency).
• In Cipla, successfully associated for USFDA inspection for three APIs on 18th to 20th October 2005 without any major observations. (3 days continuous inspection - Inspected by Dr. Mike Gavni from US Food and Drug Administration).
• In Strides, actively coordinated for USFDA inspection for ANDA approval during March 2008 and passed without any major observations. (5 days continuous inspection - Inspected by Dr. Mike Gavni from US Food and Drug Administration).
• In Strides, Successfully handled the Stability department for 5 Days Audit conducted by Mr. Neriton Ribeiro de Souza from The National Health Surveillance Agency (ANVISA) without any major observations. All minor observations were also closed before the auditor leaves the facility during 2007.
• Continual and Successful Customer audits / Inspections for cGMP compliance - By Eli Lilly and company (USA), Glaxo SmithKline (Singapore, U.K), Pfizer, Wyeth Pharmaceuticals, Reliant pharmaceuticals, Novartis, Teva Pharmaceuticals (Israel), Gen pharm and Merck Generics, Siegfried, Ranbaxy, Sandoz, Sankyo Pharma, Abbott, Sanofi Aventis etc.