Tevapharm India Limited
Manager QA Audit(API Global Compliance Group)
September 2011 — Present
• 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.