Quality Head - Savvycare&Cosmetics Pvt.Ltd - Rabale Navi Mumbai
(2025-12)
- Handling of overall site Quality Compliance. Evaluate batch records, Ensure the appropriate validations, including those of analytical procedures and calibrations of control equipment. training of the employees for all the functions in the organization.
- Implantation of Quality systems and monitoring of the same, Handling and coordination of Failure investigation. Identifying the correct root cause, CAPA.
- Handling of Customer Complaints, investigation of the complaint, Root cause identification, and deciding CAPA. Responsible for investigation and closing of OOS, OOT, deviation, and incident. Review and approval of Site Master File, Validation Master Plan, Quality Manual, SOP, BMR, BPR, APQR, MFR validation Protocols/report, and qualification protocols/report.
- Handling of External audits and ensuring compliance with the Audit findings. All-time readiness of the plant for various GMP Compliance audits, being the single point of contact on all Quality matters.
GXP Consultant - Independent - Mumbai
(2024-10 - 2025-12)
- Performs GMP Quality audits of different vendors, Laboratories and Contract Manufacturing Organizations from India and China. GMP Quality Supports to Pharmaceutical Companies.
Manager, Quality Assurance EM - Sanofi - Mumbai
(2023-04 - 2024-08)
- cGXP compliance at CMO and Release of products. Ensuring Instruments, Standards, columns, and reagent availability for Quality Control testing
- Maintain a valid Quality Agreement which is in line with the Global template clearly defining cGMP roles and responsibilities between Sanofi and the CMO's, for applicable products.
- Responsible for performing Quality audits of CMOs and suppliers of raw and packing materials and ensuring that Quality Audits are carried out as per allocation according to the defined frequencies and Annual calendar.
- Timely coordinate and communicate the Product complaint (PC) to the respective CMO's for investigation.
- Manage all Quality Issues (Deviations, Complaints, OOS, Recalls, Counterfeit, Stability failures, Critical risks etc.) according to the Quality Management system defined as per EM SOP and Sanofi Global directives.
- Ensure verification of implementation of identified CAPA at CMO during site Quality review visits and APQR review and Approval as well as Site Quality review.
- To lead, participate, support the projects of technology transfer/Continuous Improvement projects for new products or existing products identified and allocated as per project Management
- Conduct the CMO risk ranking and Nitrosamine & NDSRI risk assessment for Drug substances and Products and co-ordinate with Global Nitrosamine team for step 2 in Likely and confirmed presence.
- Implements requirements for the processes for the Quality Management System (QMS) in Veeva-Vault related to management of third parties (Quality Third Party, QTP), Events, Change Controls, Deviations and Product complaints
Manager, Analytical Development and Quality Control - Sanofi - Goa
(2008-07 - 2023-03)
- Quality Auditor for Third party sites for raw materials, Sub-contract Laboratories
- Leading a team of 10 analysts for Analytical and Quality operations
- Review and decision making on status of all the Analytical Method Development (FDC), Validation and Transfers.
- Experience in managing studies like Extractables & Leachable, Nitrosamines, NDSRIs, Elemental Impurities, and Stability studies
- Training subordinates on Regulatory guidelines, Data Integrity, cGMP, GLP, GDP, Analytical instruments, techniques, and on SOPs.
- Handling of sophisticated instruments like HPLC, GC, XRD and Dissolution testers.
- Management of Outsourced testing of Quality control samples through external testing laboratories.
- Investigation and closure of Deviations, Incidents, OOS and OOT.
- Team member in support of vendor finalization and review and approval of Quality agreement
- Review and approval of Analytical method Validation Protocols, Reports and Transfer Reports, Formulation Process Development reports of CMC Batches including QBD.
- Review and approval of GMI, Formulation Documents, Batch records. Electronic Change Controls, CAPA, Deviations, Events, Incidents.
- Review and approval of API characterization report of different vendors.
- Review of DMFs, Respond to regulatory query if any.
- Review and Approval Site Master file and Validation master plan, Specifications and Standard test preparations, Stability protocols, Stability trends and reports, Annual product review, Annual water reports and Computer system validation etc.
- Ensuring Instruments, Standards, columns, and reagent availability for Quality Control testing and maintenance of Stability Chambers, Retention Sample Room and Incubators.
Sr. Executive-Quality Control - Dr. Reddy's Laboratories - Hyderabad
(2006-09 - 2008-07)
- Active participation and interaction with auditors in various regulatory Audits
- Preparation and Review of Stability protocols and Trending of Stability study data.
- Loading and Withdrawal of Stability Samples, Planning of Stability analysis to subordinates.
- Maintenance of Working Standards, Impurity standards & Reference standards.
- Review of Raw material, Packing Material, in process, Finished products and Stability Studies data and review of Calibration reports.
Quality Control-Officer - Lupin LTD - GOA
(2005-05 - 2006-08)
- Sampling of Raw materials and packing materials
- Performance Verification of various instruments.
- Release of In process/Finished Product
- Upkeep of Stability Chambers and Stability studies of samples
- Major contributions in USFDA/MHRA Audit
- Went for USFDA Audit preparation to Lupin Bhopal (Mandideep)
