• More than 10 years handover experience in Quality Assurance in the field of Pharmaceuticals for API (synthetic & Generic), Sterile API (Oncology & Betalactums), Liquid, Dry powder, & Lyophilized Injectable.
• Trained under GMP Consultant (Trained QP& ISO auditor) for excellent understanding of EU-GMP, WHO, TFDA guidelines, and complete knowledge of FDA - 21CFR 210, 21CFR 211 and ICH guidelines (Q9 Quality Risk Assessment).
• Expertise in Regulatory Audits & Compliance – Participate in Regulatory Audits (as Auditee) and writing FDA 483 Response / EU Audit Response and other Customer Audits.
  Quality Management Systems - QMS elements like Customer Complaints, Investigations, Deviations, CAPA, Change Control, & Internal Audits (Review, verify root cause, approval, Closure).
  Qualifications & Validations – Vendor/Supplier Qualification, Production/Utilities/Laboratory equipment Qualification along with analytical method validation, media fill simulation, sterilization method validation, manufacturing process validation and cleaning validations (Review validation protocols & reports, Preparation of Quality Risk Assessment)

Mohan is a Quality Consultant with nearly 20 years of experience in the Pharmaceutical, Cosmetics, Biopharmaceutical, Medical Devices, Packaging, Clinical Research and Food industries.

Prior to consultant, Mohan worked in different pharmaceutical positions as Senior GMP Consultant, Head of Quality, Project Leader of Validation, Head of Quality Control in INDIA and Quality Engineer in UK.

Expertise in Plant design & Start Up, FDA Warning Letter/audit response, Third-party auditing, Lab design/set-up, Regulatory filings-DMF/(A)NDA, C&Q, Validation, Research & Product Development, Training and Regulatory Inspection readiness associated with drugs/cosmetics/medical devices/packaging/Food.

Expertise in QMS implementation for ISO 9001,ISO 13485, cGMP, GLP, GDP, GCP, GEP.

Directed project for API product launch readiness in 18 months with Taiwan FDA (PIC/S GMP) inspection at Taichung; and, also two facility expansions for beta lactum products in Tainan.

Developed and implemented quality strategic, manufacturing technology, filling equipment selection with fully integrated isolators technology, lyophilization and conceptual designs for aseptic processing facility in Taiwan. 

Successful implementation of Quality systems in 5-Taiwan based project & cleared regulatory audits for TFDA (PIC/S GMP), USFDA, MHRA, AEMPS & KFDA

Mohan is certified by the International Register of Certified Auditors (IRCA) as an Auditor for Quality Management Systems (QMS). Being a Certified Auditor, Mohan as audited more than 50 Quality audits as Lead Auditor till date, for manufacturing companies such as API, Excipients, intermediates, Vaccines, Formulations, Cosmetics, Food, Medical Devices, Packaging, Parenteral & Contract Laboratories.

• Chartered Chemist (Bachelor of Science)
• Member of the Royal Society of Chemistry (UK)
• Member of the American Society of Quality (ASQ)
• Member of Pharmaceutical association like PDA/ISO/ISPE
• Member of Food Safety Preventive Controls Alliance (FSPCA)
• Certified as ISO 13485:2016 - Medical Devices QMS Lead Auditor
• Certified as ISO 9001-2015 - QMS Lead Auditor
• Certified as PCQI for Human Food – FSMA Qualified Auditor
• Trained as “Qualified Person - QP” (UK)