Prabhu Ganesan

• A highly experienced Quality Assurance professional with 16 years of success in the pharmaceutical, medical device, and consumer industries, seeking a challenging position to utilize my expertise and deliver exceptional results through a result-oriented approach.
• Proficient in various quality assurance areas, including SOPs, Change Control, OOS, Deviation, Quality Risk Assessment, Customer Communications, and CAPA. 
• Well-versed in EU and US regulations and guidance of cGMP, with exposure to regulatory agency inspections. 
• Possess a thorough understanding of USFDA standards and quality systems (ISO 9001 and ISO 13485). 

 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

• 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.

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. 

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.

•  Successfully drafted an FDA response letter that was accepted by the USFDA.

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.

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.

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.

• 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

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.

M. Sc. in Analytical Chemistry