Head Quality & Compliance - Indoco Remedies Ltd. - India
(2024-05)
Leading the team of Quality(QA, QC and Microbiology) & Compliance having the approval from all leading regulatory agencies eg: USFDA-US,MHRA-UK,TGA-Australia, MCC-South Africa, EU GMP-Europe, WHO- Geneva, PMDA-Japan, ANVISA-Brazil, INVIMA-Colombia, SMDC-UKRAIN, Infarmed-Portugal, IGJ-Netherlands, Health Canada-Canada, TFDA-Taiwan, Pharmacy and Poison Board-Kenya, BfArM- Federal Institute for Drugs and Medical Devices-Germany.
Head Quality Assurance - Sun Pharmaceuticals Industries Ltd. - Halol, India
(2017-03 - 2024-05)
Biggest Manufacturing Site in Asia, No. 1 Pharmaceutical Company in India and fourth largest specialty generic company in World having the approval from all leading regulatory agencies eg: USFDA-US,MHRA-UK,TGA-Australia, MCC-South Africa, EU GMP-Europe, WHO- Geneva, PMDA-Japan, ANVISA-Brazil, INVIMA-Colombia, SMDC-UKRAIN, Infarmed-Portugal, IGJ-Netherlands, Health Canada-Canada, TFDA-Taiwan, Pharmacy and Poison Board-Kenya, BfArM- Federal Institute for Drugs and Medical Devices-Germany. Spearheading a corporate quality team of 78 members (Direct), 658 members (Indirect) for obtaining better results through hassle free operations in order to maintain the timely deliveries, quality and the cost.
- Responsible for Operation of QA, QC & Microbiology.
- Responsible for ensuring overall oversight of manufacturing/laboratory operation of all 07 Formulation manufacturing site.
- Responsible for oversight of 126 external manufacturing site globally including site in US, Europe, Malaysia, Greece, Bangladesh.
- Responsible for defining, implementing, managing and controlling all quality assurance systems in order to ensure quality of the product in compliance with established procedures and regulatory requirements.
- Responsible for auditing the external Manufacturing site, for Qualification and for Routine oversight program.
- Market complaints, failures, deviations are investigated and corrective and preventive actions are implemented as per set timeline
- Compliance to regulatory requirements on product, process and release procedures
- Release of safe and effective drug products from site as per c-GMP and regulatory requirements.
- Reviewing and approving the change control, OOS, OOT, Laboratory event, Deviation, OOC, Market Complaint investigation reports, Corrective Actions and Preventive Actions, Annual Product Reports/Product Quality Review Report, Protocols and reports, Field alert reports, Product recall forms, Training Documents, Track-wise Records, specifications Other GMP, Regulatory, Administrative and Commercial documents
- Conducting Perform Gap & Root Cause Analysis at regular interval to identify gaps in quality system and resolving same.
- Ensuring that quality checks of raw materials, intermediates, by-products, finished product and packing materials are managed as per laid down procedures
- Developing supplier assessment systems, identifying areas of quality failures & taking steps to rectify the system wide preventive and corrective actions to avoid the reoccurrences
- Reviewing and approving master validation plan, drawings, layouts, URS, DQ, FAT, SAT, IQ, OQ, PQ, of various equipment's/instruments, area and utilities.
- Resolving all internal & external customer complaints; taking timely corrective & preventive actions by sharing countermeasure sheet and preventing the recurrence
- Conducting Employee training program.
- Analyzing Quality Index/Matrix, to, lead the Management Quality Review Meet
- Evaluate the data for trends indicative of product performance, method performance and analyst performance.
- Responsible for reviewing and approving qualification/Validation of various equipment and utilities like Steam Sterilizer, Dry Heat Sterilizer Tunnel, Liquid Filling Line, Water System, HVAC System, process (Aseptic process simulation, Cleaning Validation, Process Validation, Packing Validation) and computerized system validation etc.
- Responsible to reviewing and approve the change control, technology transfer protocols/reports, analytical method transfer protocols/reports BMR, BPR, SOP, OOS, OOT, Laboratory event, Deviation, OOC, Market Complaint investigation reports, Corrective Actions and Preventive Actions, Annual Product Reports/Product Quality Review Report, Validation Protocols and reports, Field alert reports, Product recall forms, Training Documents, Track-wise Records, specifications Other GMP, Regulatory, Administ
- Responsible for auditing the suppliers and internal facility (GMP, routine For-Cause audits and Due Diligence audits) which included audit scheduling, execution, reporting, follow-up and closure of the audits.
- Responsible for audit system enhancements to ensure continuous compliance, development & improvement of the Quality Audit program.
- Responsible for Risk Profiling of suppliers to determine the audit frequencies based on the risks.
- Support the supplier sites and departments with developing and executing remediation actions to drive sustainable compliance to regulatory and evaluate the appropriateness of proposed CAPAs and remediation plans, monitor the progress and evaluate the effectiveness of the CAPAs implemented.
- Expert in Preparation of clear concise and objective audit reports of the highest level of quality that ensure that senior management is appraised of identified risks and that appropriate corrective action plans are implemented.
- Responsible for ensuring availability of adequate resources, including manpower to maintain compliance with GXP requirements
- Responsible for assuring all time readiness of site for regulatory agency inspections\internal audits and appropriate implementation of corrective actions regarding observations made by the agencies\internal audit teams along with cross functional team.
- Provide early visibility of regulatory / compliance issues, to management through outstanding skill of risk management.
- Facilitating internal and regulatory agency audits, ensuring that findings from site audits are understood, assessed and addressed site wide in a comprehensive manner.
- Expand knowledge base through proactive knowledge sharing and collaboration with all cross functional team/stakeholders.
- Ensuring compliance to regulatory requirements on product, process and release procedures.
- Ensure release of safe and effective drug products from site as per c-GMP and regulatory requirement.
- Ensure that adequate controls on starting materials, intermediate products, and bulk products, finished products and other in-process controls, calibrations, and validations are carried out.
- Achieving excellence in subject matter expertise to enhance the understanding for evaluating the risk of process and provide mitigation plan for ensuring high quality in product.
- Tracking, reporting of quality performance indicators (KPIs) that measure the quality and compliance on a routine basis and identified risks related to quality and compliance.
- Monitoring industry trends/issues faced internally and identify scope for improving Site quality assurance management and processes.
- Contributing to team effort by accomplishing results as needed.
- Reviewing quality metrics and providing status to the management with respect to monitoring of quality systems & processes for continuous improvement efforts in drug manufacturing.
- Responsible to ascertain Quality of recalled product and performing in depth evaluation for reasons for recall and ensure effective actions on root cause identified.
- Implementing and maintaining a Quality Risk Management system along with cross functional team to ensure that risks are adequately controlled in accordance with current requirements
- Defining operational strategy and roadmap for quality assurance management at site; managing site quality assurance goals and strategy in line with company compliance, product quality management objectives and regulatory requirements
- Developing site quality assurance revenue and capital budgets and headcount projections, track and manage expenditures and headcount to budget over the fiscal year
- Responsible to implement the actions enabling in reduction of Health, Safety and Environmental Risks and Hazards.
- Responsible to address all quality related issues of site.
- Implemented the 21st Century Quality concept, based on quality by design right from beginning of product life cycle, where the evaluation of product/process/Method robustness to be monitored and appropriate actions were taken based evaluation.
- Expert in designing the world class state of art facilities by providing Quality inputs for facilities during design/project phase, by implementing the proactive approach of quality by design.
- Responsible for development of strategic and technical quality plans on support of the GMP.
- Responsible for implementation of Quality Management Maturity Program as per current thinking of FDA.
Head Quality Assurance - Zydus Life Sciences Ltd. - Goa, India
(2014-09 - 2017-03)
Section Head QA - Naprod Life Sciences Pvt. Ltd. - Boisar Tarapur, Maharashtra, India
(2013-05 - 2014-08)
Quality Assurance Section Head - Paksons Pharmaceuticals Pvt. Ltd. - Bahadurgarh, Haryana, India
(2011-10 - 2013-04)
Management Staff(Manufacturing) - CIPLA Ltd. - Pithampur, Indore, India
(2010-08 - 2011-09)
Quality Assurance Officer - Paksons Pharmaceuticals Pvt. Ltd. - Bahadurgarh, Haryana, India
(2008-08 - 2010-07)
