Training Programs/Services
Professional Profile
Name Mr akhilesh khale
First Language english
City watanobbi
Country Australia
Professional Type
Lead Auditor - Management Systems - ISO 9001, 14001, 45001, 27001 and 31000
Observational Assessment
Memberships, Qualifications Lead Auditor-Quality Management Systems, GMP, Risk Management and Medical devices. M.Sc. Microbiology, Certificate IV in Training and Assessment. Six Sigma-Lean Management.
Experience Akhilesh is an experienced senior executive with over twenty five years of industry experience mainly in Pharmaceuticals, sterile manufacturing ( including antibiotic preparation),Sterile compounding, Vaccines, Biotechnology, Dairy , Cosmetics and Medical devices.
Akhilesh is a member of Microbiological society of Australia.
He has strong background in Quality assurance , quality control, product development and process improvement. These capabilities have significant relevance to a private enterprise small business, to a large corporate business and exposed to different quality management systems.
Strong understanding of ISO 9001, GMP/PICS guidelines, Risk management ,FDA and EU requirements.
Experience in dealing with TGA, Medsafe, FDA and EU regulatory bodies.
He has worked on development, implementation and maintenance of QMS, Staff training for GMP, OHS and Internal audits.
Industry Standards and codes