
Timeline
Skills
AuditingHplcGmpGxpBiotechnologyChange controlRegulatory affairsStandard operating procedureValidationU.s. food and drug administrationQuality assuranceCleaning validationRegulatory requirementsQuality systemCsmV&vQuality auditingPharmaceuticsRegulatory submissionsAndaCorrective and preventive actionAuditsPharmaceutical industryGood laboratory practiceTechnology transferGlpCapaFdaSop21 cfr part 11About me
I have over 22 plus years of experience in Quality Assurance, Compliance, Audits, Third Party Manufacturing. Significant international experience in multi-cultural and multi-national assignments. I have experience in Finished Dosage Form (FDF), Auditing of API/FDF, Third Party Quality Management and Corporate/Global QA.
Education

Amravati university
1989 - 1993B.pharm pharmaceuticals
Birla institute of technology and science, pilani
2018 - 2020Master of technology in pharmaceutical operations and management pharmacy 7.8 cgpaPost graduation 👨🎓
Experience

Usv private limited
Jan 1993 - Jan 2000Officer
Glenmark pharmaceuticals
Jan 2000 - Jan 2007Asst. manager qa
Wockhardt ltd.
Jun 2007 - Apr 2009Worked in Quality Assurance dept. and was responsible for the Quality of Loan licence and Third Party products to be manufactured for Wockhardt. Ltd. Licencing activity, Approval Artwork, Investigation of market complaints, Validation of product, scale up off product, Change control, deviation & incident handling and investigation.Quality audits for vendor development and routine audits as per plan. Worked in Quality Assurance dept. and was responsible for the Quality of Loan licence and Third Party products to be manufactured for Wockhardt. Ltd. Licencing activity, Approval Artwork, Investigation of market complaints, Validation of product, scale up off product, Change control, deviation & incident handling and investigation.Quality audits for vendor development and routine audits as per plan.
Asst. Manager QA
Jun 2007 - Apr 2009Asst. Manager QA
Jun 2007 - Apr 2009

Mylan india p. ltd
Apr 2009 - Aug 2013Quality assurance
Mylan
Apr 2009 - Aug 2013Global quality assurance auditorSr. Manager Global Quality - Responsible for Quality of Third Party products manufactured for Mylan & Audits.

Eli lilly and company india
Sept 2013 - Jan 2023Responsible for auditing in Asia Pacific countries.
Associate Director Supplier Audit (Asia)
Mar 2018 - Jan 2023Sr. Global Quality Auditor (Asia Pacific Countries)
Sept 2013 - Mar 2018

Eli lilly and company (india) pvt. ltd.
Mar 2018 - Jan 2023Associate director supplier audit (global quality)
Eli lilly and company
Jan 2023 - nowAdvisor - gqaac at eli lilly and company
Licenses & Certifications
- View certificate

Balancing work and life
LinkedinJun 2020 - View certificate

Business etiquette: phone, email, and text
LinkedinJun 2020 - View certificate

Thriving @ work: leveraging the connection between well-being and productivity
LinkedinMay 2020
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