EXPERIENCE
Jun 2022 – Present
Smartpoint Technologies Private Limited
QA Manager, Quality Management, Chennai, India
- Leading Quality Management including quality control compliance
- Driving QMS, Software release, change controls, audit & compliance & Supplier Qualification.
- Review and approval of SOPs, Validation documents.
- Review and Approval of CAPA, CAPA Effectivenessand Quality Risk Management
- Actively participating in customer audits as well as in inspections and support all activities to ensure inspection readiness.
- Defining and executing processes for continuous improvement efforts
Achievements
- Faced the ISO 9001: 2015 Audit with zero observations.
- Implementation of CAPA from Offline format to Online format in Confluence.
- Implementation of Change Control in Confluence.
May 2021 – Apr 2022
QM Healthcare Manager
Beiersdorf India Pvt Ltd, Mumbai, India
- Responsible for review and release of products as per the SOP.
- Preparation and review of documented procedures, formats and their control.
- Mange the 3PM by auditing the facility and maintenance of Audit report.
- Preparation of the specification and maintain their records.
- Maintain the records for the complaints and its records.
To support the quality functions through compliance of Non-conformances, Deviation, OOS and CAPA related to the products.
Feb 2019 – May 2021Quality Assurance Manager
Vitamins Direct Services Pvt Ltd, Mumbai, India
- Responsible for reviewing and releasing inspections, ensuring cGMP and regulatory compliance, and documenting procedures through SOPs. Also, overseeing Label artwork, Complaints handling, Product return process, and maintaining records of Non-conformances, Deviation, OOS, and CAPA.
Achievements:
- Successfully drafted an FDA response letter that was accepted by the USFDA.
Nov 2017 - Feb 2019Lead Quality Assurance
Jay Precision Pharmaceuticals Pvt Ltd, Mumbai, India
- Review and release of inspections as per quality procedures.
- Ensuring GMP compliance in the Plant (USFDA, CE, ISO 13485), maintaining documented procedures, and assisting with supplier qualification.
- Supporting quality functions through compliance of Non-conformances, Deviation, OOS, and CAPA.
Jan 2013 – Nov 2017Assistant Manager QA
Phoenix Innovative Healthcare Manufacturers Pvt Ltd, Navi-Mumbai, India
- Responsible for reviewing and releasing inspections, validation, and design processes in line with quality procedures and guidelines.
- Conducting stability studies as per ICH guidelines, assisting with supplier qualification, and managing calibration of laboratory and manufacturing equipment.
- Faced the US-FDA for the drugs manufacturing unit as per 21 CFR 211 requirements during 17 – 21st Oct 2016.
Jul 2008 – Jan 2013Senior Officer Quality & Compliance
Johnson and Johnson Limited, Mumbai, India
- Expertise in reviewing analytical reports for Raw Materials, Packaging Materials, Intermediates, and Finished products in accordance with quality standards.
- FDA approved Chemist skilled in instrumentation and chemical methods, preparing Annual Product Reviews, supporting Analytical Method Validation, Process Validation, and conducting timely Stability Studies.
Achievements
- Won on the Project “Quality Improvement project for the Band-Aid and Powder Workshops” in the year 2010.
- Won on the Project “Sector Regulatory Compliance (SRC) Audit” in the year 2011. Also won Regional award (Encore Platinum Award) for this project.
- Won on the Project “Enterprise Regulatory Compliance (ERC) Audit” in the year
May 2007 – Jul 2008QC Chemist
RFCL Limited, Navi Mumbai, India
- Proficient in sample analysis and handling various instruments such as GC, UV-Visible spectrophotometer, AAS, etc. Experienced in instrument calibration (AAS, Polari meter, Melting point apparatus, pH meter, refractometer), NABL assignments.
