Lead Auditor – Integrated Management system - TUV INDIA PVT. LTD., Mumbai, India - TUV NORD GROUP - Mumbai, India
(2023-08)
Inspection, Testing and Certification
- The Key responsibility includes planning, managing, and delivering audits effectively to ensure compliance with applicable standards (Quality management system, Environment management system, Occupational Health and Safety management, Food safety management System, cGMP certification, Educational Organizations Management System, Safety assessor audit, second party audits) across various segments of industries.
- Team Leadership includes proper coordination, communication and leading audit team members, delegating tasks, and managing the overall audit process.
- Their primary role involves verifying system implementation as per scope applicability and ensuring compliances as per management system certification, and overall documentation as per accreditation and scheme requirements. fostering continuous improvement.
- To foster continual improvement to improve system integration.
Assistant Manager - Quality Assurance - Pharmanza Herbal Pvt. Ltd, Anand, Gujarat, India - Anand, Gujarat, India
(2018-07 - 2023-08)
Manufacturing of Active Pharmaceutical Ingredients and Botanical Extracts; Manufacturing of Tablet, Capsule, Oral liquid Preparations and other dosage forms
- To ensure Good Documentation practices, and current Good Manufacturing practices implementation as per standard guidelines (21 CFR Part 111, 21 CFR Part 117, 21 CFR Parts 210 and 211) within manufacturing facilities.
- Regulatory compliance of the product to applicable legal and industry regulations, local, national, and international laws, as well as industry-specific regulations, standards relevant to its operations (FDA, USFDA, FSSAI and others as applicable).
- Product registration and approval through online portal of FDCA Gujarat.
- Risk Management framework through identification of various risk and its mitigation. To perform risk assessment to cater requirements related to quality, environment and safety aspect through process safety risks, hazard identification and risk assessment, environmental aspect-impact assessments, food safety plan, food defense plan, and recommend appropriate control measures and to monitor effectiveness of risk-control measures.
- To Lead and coordinate for various external audits performed related to manufacturing facility certifications and approval from regulatory and statutory bodies such as NSF International, ISO 9001:2015 (Quality Management System), HACCP, ISO 22000: 2018 (Food Safety Management System), USP (GMP Quality Systems certified and Dietary ingredients), FDCA (Gujarat), FSSAI, USDA Organic, Ecovadis (Sustainability), SEDEX (SMETA, Four Pillar Audit), Kosher and Halal. The coordinator towards the implement
- Coordinator for Sedex Members Ethical Trade Audit (SMETA, Four Pillar Audit) with all required documents, third party test report based on standard requirement in coordination with consultation and customer.
- Development and implementation of framework towards, Environment and Occupational Health and Safety Management system.
- Ensure compliance with applicable environmental, health, and safety laws, regulations, and company policies.
- Responsible person in coordination with safety officer towards information and documentation related to workplace conditions, emergency procedures, Onsite emergency plan, Compliances towards labour laws and other statutory compliances, employees training records, Safety committee records and minutes of meeting, monitoring and master list records related to firefighting equipment's, Hydrants system, Mockdrill reports, Hoist & lift testing reports and other requirements to be ensured for EcoVadis
- For EcoVadis assessment, responsible person towards information and documentation related to EHS procedures, energy consumption, water management, ETP (Effluent Treatment Plant) operations, Hazardous waste management, Greenhouse Gas targets, Environment key performance indicators, and other requirements in coordination with cross functional team members from other departments to b ensured.
- To ensure operation of effluent treatment plant is functional and as per pollution control board norms, testing of treated effluent shall be performed from externally laboratory for chemical oxygen demand (COD), biological oxygen demand (BOD), total suspended solids, total dissolved solids, other parameters and its records documentation.
- To ensure monitoring and measurement details related to hazardous waste management, workplace environment air quality and noise level, ambient air and noise level, illumination level, stack emission monitoring, through a stack of Boiler, Diesel Generator in coordination with a third party laboratory. Ensure proper documentation and monitoring of environmental parameters and support implementation of environmental management programs.
- To ensure and review record for compliances related to inspection, maintenance of fire protection and prevention program at manufacturing facility of fire alarm devices, fire fighting and suppression equipment and its training record.
- To ensure the change management process, out of specification handling and deviation process are defined and implemented within organization. Review change controls for potential EHS impacts and to ensure EHS requirements are considered before implementing changes to processes, equipment, facilities, or materials.
- Equipment Qualification and Process Validation activities. Process validation in coordination with Production team and Research and development department as cross functional task.
- To ensure batch manufacturing and batch packing master records as per master formula and process details are documented. To ensure product specifications preparation and alignment as per customer requirement.
- Batch release process for the product and its documentation.
- To ensure the stability details related to the product are performed as per protocol and details reviewed periodically.
- Supply chain developments in coordination with purchase department and further to review, perform vendor qualification as per process at organization level.
- To inculcate good GMP knowledge and its awareness among various stakeholders internally through training and other activities.
- Responsible for the investigation and closure of all customers compliant through use of various tools for identification of root cause analysis, correction and corrective action for non conformities identified within system.
- Incident & Accident Management through investigation of accidents, near misses, unsafe acts, unsafe conditions and identification of root-cause analysis to ensure CAPA implementation and effectiveness checks.
- To plan, schedule and perform internal audit, to ensure corrective and preventive actions (CAPA), effectiveness and its closure.
- To coordinate Management review meeting, report project results and its update to senior management.
Head - Quality Assurance - Pharmanza Herbal Pvt. Ltd, Anand, Gujarat, India - Anand, Gujarat, India
(2021-07 - 2023-07)
Additional designation during Assistant Manager tenure
Assistant Professor - Anjuman-I-Islam's Kalsekar Technical Campus, School of Pharmacy, Panvel, Navi Mumbai, Maharashtra, India - Panvel, Navi Mumbai, Maharashtra, India
(2013-07 - 2018-07)
- To facilitate the course work related teaching of Pharmacognosy, Pharmaceutical Biotechnology, Microbiology, Herbal Drug Technology and Pharmaceutics to Final year and Third year B. Pharm students.
- Industry Institute Committee member at Campus level for MOU, Industrial training, and collaboration projects for students with industry.
- Examination Committee member to facilitate examination process of pharmacy section
- Member of NBA and NAAC accreditation committee member
- Placement Committee member for Placements of final year students in different areas of Pharmaceutical sector within the industry.
- Facilitation of all phases of bench research to include Project Management skills, Laboratory management, documentation and external training.
Lecturer - NCRD'S Sterling Institute of Pharmacy, Navi Mumbai, Maharashtra, India - Navi Mumbai, Maharashtra, India
(2011-08 - 2013-07)
- To facilitate the course work related teaching of Pharmacognosy, Pharmaceutical Biotechnology, Microbiology, Herbal Drug Technology and Pharmaceutics to Final year and Third year B. Pharm students.
- Industry Institute Committee member at Campus level for MOU, Industrial training, and collaboration projects for students with industry.
- Examination Committee member to facilitate examination process of pharmacy section
- Member of NBA and NAAC accreditation committee member
- Placement Committee member for Placements of final year students in different areas of Pharmaceutical sector within the industry.
- Facilitation of all phases of bench research to include Project Management skills, Laboratory management, documentation and external training.
