Care Pharma Consultant

CGMP Auditing

Vendor / Supplier Qualification Audits for Key Starting Material (KSM), Raw Material (RM) & Packaging Material (PM)

Third Party Manufacturing Site Audits

Contract Manufacturer Audits

Gap Assessment Audits

Investigation Audits

Regulatory Compliance Verification Audits (Pre & Post)

QMS Verification Audits

Internal Audits

Social Audits

Customised Audits as per Client Need

Quality Consulting

Process Simplification

Productivity Improvements

Quality Culture Transformation

6S Implementation

Regulatory Audit Consulting

Automation / Digitisation

Quality Consultant

QA Documentations

Computer System Validation (CSV)

Validation / Qualification of Equipment & Utility

CGMP Training

On-Site & Virtual Training on all available CGMP Topics

Motivational Training

Soft-Skill Training

Leadership Training

Quality Culture Training

Customised Training as per Client Need

ISO Trainings

Advanced GMP Training

Validation / Qualification Trainings

Achievements

Track record of successfully completing 150+ cGMP audits across the globe.
Successfully cleared EU-GMP, ANSM, US FDA, PIC'S and other regulatory audits for Indian and Global Pharma Companies in India.
Setup a Quality Standards (SOPs & QMS System) for Sterile & Non-Sterile USFDA Pharma Company with 100+ products and turnover of INR 150 Crores.
Successfully completed project of QC Productivity Improvement by Process Simplification and Low Cost Automation for leading Indian Pharma Company.
Successfully completed "Quality Culture Transformation" project of 350+ SOPs simplification and Global Standard Implementation for a MNC life-science organization with 3000+ lifesciences products.
Worked on Process Simplification project for leading Indian Generic Manufacturing Company with annual turnover of approximately INR 10,500 Crores and 600+ formulations (OSD).
Worked on Process Simplification and Productivity Improvement project for Global Generic Manufacturing company with annual turnover of approximately INR 3,000 Crores and 45+ Formulations (OSD / LVP).
Worked on Quality Improvement & Process Simplification Project for Indian MNC API Manufacturing company with annual turnover of approximately 4500 Crores and 50+ Products (Intermediate & APIs).