Introduction
Balaji. K (Balaji Krishnan) is
A Quality System Consultant (Independent Consultant) and Technical Trainer
A CQI IRCA Certified Lead Auditor- QMS (IS 9001:2015) & MD-QMS (IS 13485 :2016).
With more than 25 years’ experience, worked for various pharmaceutical / vaccine manufacturing organization.
Passionate on Quality & Regulatory Compliance, which led him to support various pharmaceutical / vaccine / medical devices manufacturing organizations since March 2020.
Keen to ensure sustainable quality compliance, as per various regulatory requirements such as USFDA, MHRA, TGA,WHO- Geneva, PICs- Ukraine , MCC- South Africa etc.
A Subject Matter Expert (SME) of
- Sterility Assurance,
- Microbiological Assurance,
- Quality System Compliance
- Technical Training
