• Apr 2014 - Present

 Planning and scheduling of all the works at Quality Assurance Department Handling of customer audits, regulatory audits and CAPA related to the audits Review and evaluation of QA (cGMP) reports and compliance Reviewing of QA related documents and approval Review and verification of Validation Master Plan Review and approval of QA related validation protocol and reports Expertise in handling Nonconforming products Expertise in handling Rejected/Recalled materials Expertise in handling of Batch Failure investigation and CAPA Expertise in handling returned recalled product, OOS, OOT etc. Review of procedures or documents viz SOP, and specifications etc. Recruitment of QA personnel Review and approval of annual product review Vendor qualifications, audits and evaluation. Review and Handling of Quality Agreement (as applicable). EHS core committee member and implementation of procedures in quality department. Member of Post Vigilance Group for monitoring and handling of complaints Proficient with the regulatory requirements for the Active Pharmaceutical Ingredients manufacturing and the subsequent distribution across globe Expert in identifying and establishing quality system across the functional departments across the organization to meet the WHO and ISO standards Responsible for spearheading the quality certification programs including ISO/WHO/GMP Responsible for the overall smooth function of the quality aspects of the organization To train the QA department personnel with respect to the quality system procedures and cGMP.  Responsible for trouble shooting customer complaints/review of contract with respect to quality requirements, preparing and approving of quality plan Show less

• Apr 2010 - Mar 2014

 Review and verification of Validation Master Plan Review and approval of QA related validation protocol and reports Handling of Batch Failure Investigation and CAPA Handling of rejected/recalled materials. Handling of returned recalled product, OOS, OOT etc Reviewing documents [Procedure (SOP, IOP, EOP, GAM and Specifications etc.), validation protocol and reports, Batch records, checklists, qualification documents etc.] Approval of Quality management system documents including SOPs, specifications and other documents. Recruitment of QA personnel Show less

Team Leader

• Mar 2006 - Mar 2010

 Review and verification of Validation Master Plan  Review and approval of QA related validation protocol and reports  Handling of Batch Failure Investigation and CAPA  Handling of rejected/recalled materials.  Handling of returned recalled product, OOS, OOT etc  Reviewing documents [Procedure (SOP, IOP, EOP, GAM and Specifications etc.), validation protocol and reports, Batch records, checklists, qualification documents etc.]  Approval of Quality management system documents including SOPs, specifications and other documents.  Recruitment of QA personnel Show less

Senior Lecturer - Chemistry

• Dec 2004 - Feb 2006

Lecturer in Chemistry Lecturer in Chemistry