Experience

Merck India
• India
• Pharmaceutical Manufacturing
• 200 - 300 Employee
• Senior Specialist - Quality Assurance

  • Sep 2021 - Present


Syngene International Limited

• India
• Research Services
• 700 & Above Employee

• Assistant Manager – Quality Assurance

  • Apr 2014 - Sep 2021

  • A competent professional with over 12 years of experience in Quality Assurance& Regulatory Compliance in Pharmaceutical industry • Successfully managed 4 US-FDA, 1 TGA, 2 EU-GMP, 1 PMDA and 2 MHRA audits. Provided support to the leads in these audits and achieved NAI status in all the FDA inspections. • Faced more than 50 customer audits • Effective and professional communication skills • Subject Matter Expert in review of master documents (BPCRs), preparation, review and approval of APQR, change management, process validation and cleaning validation, vendor audits. • Trained auditor for conducting cGMP audits (Internal and external) • Skills in achieving cost savings across assignments and minimizing performance bottlenecks for attaining high productivity with optimization of men, material and machine • Expertise in Project Management for Track wise Quality solutions Implementation (Change management, Investigation, Commitment action and CAPA) • Established and effectively managed QMS at Syngene. Show less


Dr. Reddy's Laboratories
• India
• Pharmaceutical Manufacturing
• 700 & Above Employee
• Senior Executive – Quality Assurance

  • Apr 2012 - Apr 2014

AUROBINDO PHARMA LTD
• India
• Pharmaceutical Manufacturing
• 700 & Above Employee
• Assistant (S2) – Quality Assurance

  • Jun 2007 - Apr 2012