Experience

Zoetis Pharmaceutical Research Private Ltd

• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Associate Director Quality Assurance

  • May 2016 - Present

  •In Leadership role and member of Pharmaceutical Science Leadership Team. •Providing direction on Development QA aspects of API, Formulation & Biopharmaceutical products & ensure the compliance in line with regulations, guidelines, company policy. •Responsible for global development QA operations. •Managing Quality Management System, documentation & Quality training programmes. •Quality oversight of GMP works at CROs & Zoetis GMS sites. •Certified global auditor to perform the Quality audits (global) •Support CMC documentation and product filing. •Designed the Quality requirements & policy at various stages of product development for the innovator product development. Aligned the procedure, guidelines accordingly. •Leading the GMP Quality Control activities. •Mentoring Engineering & production team in line with 21 CFR part 11 requirements, other Qualification/validation aspects and documents prepared in line with requirements. •Handling of Letter of Queries, PAI inspection from Health authorities. •Resolve Quality related issues with solution based approach & handling conflict management. •Mentoring cost improvement projects with six sigma and Lean methodology. •Support & coordination with GCP/GLP QA teams. Show less



Sun Pharmaceuticals

• India
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Deputy General Manager- Corporate Quality Audit

  • Mar 2015 - Apr 2016

  •Leading the vendor audit team. •GMP Auditing of manufacturing sites, vendors of API, Excipient, Packaging material, Contract manufacturing locations & central ware house etc.(Supply chain management). •Managing audit schedules, audit team. •Review of audit report and compliance report. •Activities related to vendor Qualification. •Continuous training to team members for the enhancement of knowledge of audit team members. •Submission of monthly and quarterly report to the top management. •Preparation of budget and monitoring of expenses. •Conducted 35 audits including API supplier, excipient supplier, and contract testing laboratory. Report review, approval and closure of about 200 audits. Show less



Lupin

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Manager Corporate QA

  • Sep 2012 - Mar 2015

  Manufacturing site Audits and compliance Supplier and third party audits Implementation of Quality systems and monitoring at all sites Preparation of Management Quality reviews and tracking the action points. Manufacturing site Audits and compliance Supplier and third party audits Implementation of Quality systems and monitoring at all sites Preparation of Management Quality reviews and tracking the action points.



Sandoz

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Manager- Quality Compliance

  • Jun 2006 - Sep 2012

  Quality assurance (Product Development QA) Internal Audits, Implementation of new systems, Supplier Audits, Handling of ANDA projects Novartis Certified auditor Quality assurance (Product Development QA) Internal Audits, Implementation of new systems, Supplier Audits, Handling of ANDA projects Novartis Certified auditor



Strides

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Team Leader- Design Quality Assurance

  • Apr 2005 - May 2006

  Handling of Design Quality assurnace, Supplier Audits, Auditing product development of generic business. Handling of Design Quality assurnace, Supplier Audits, Auditing product development of generic business.



Johnson & Johnson

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Senior Officer

  • Jun 2000 - Apr 2005

  Handling In process Quality assurance. Six Sigma & Lean methodology projects, Hanlding of Contract manufacturing. Testing of RM, PM & FP. Implementation of new procedures. Handling In process Quality assurance. Six Sigma & Lean methodology projects, Hanlding of Contract manufacturing. Testing of RM, PM & FP. Implementation of new procedures.



Merck Group

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Research Scientist

  • Jul 1999 - May 2000

  Analytical method development. Method validations. Stability studies. Testing of RM, PM & FP, Intermediates. Analytical method development. Method validations. Stability studies. Testing of RM, PM & FP, Intermediates.



Ciba Ckd Biochem Limited

• India
• Appliances, Electrical, and Electronics Manufacturing

• Chemist- Quality Assurance

  • Jan 1997 - Jun 1999

  Testing of Raw Materials, Finished Product, Stability studies Quality Assurance and Quality Control Documentation Instrument Qualification and calibrations Support In process testing to Manufacturing Plant Testing of Raw Materials, Finished Product, Stability studies Quality Assurance and Quality Control Documentation Instrument Qualification and calibrations Support In process testing to Manufacturing Plant