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Nirav J Shah

Nirav J Shah

Manager QA Audit(API Global Compliance Group)

Tevapharm India Limited

Hyderabad, Other

Corporate Quality Assurance and API Vendor Audit


Tevapharm India Limited

Manager QA Audit(API Global Compliance Group)

• Planning, preparation and execution of vendor qualification, regular audit and re-audit for Active Pharmaceutical Ingredient / Advance Starting Material / Excipients as per local regulatory requirements and regulatory requirements of the regions in which the product is marketed to meet the department goal as a Lead Auditor.
• Report preparation for audit as per regulatory requirement and need to bring critical observation to the management within stipulated timeframe.
• Post audit follow up and support to the vendor to ensure the compliance as per regulatory requirement.
• Evaluation of re-audit criteria based on thorough risk analysis as per guideline.

Career medium 04


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cGMP and ISO system implementation from scratch, Equipment Qualification, Plant commissioning, Process validation, Customer Audit

Faculty of Tech and Engineering

Masters, Industrial Technology

E.N.Ginwala High School

12th, Science