Download PDF

Work experience

Jan 2011Present



§  Accountable for the Preparation and execution of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) of Water System (Purified Water), HVAC System, Pharmaceutical Process Equipment.<?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /><o:p></o:p>

§  Analyzing Bulk and its approval for production alongside monitoring of online QC issues in lieu with the quality parameters in each stages of production.<o:p></o:p>

§  Oversee to ensure that all the components of a complete, acceptable QC and QA program are in place.<o:p></o:p>

§  Deftly implemented current Good Manufacturing Practices and GLPs in drug product laboratories, custom manufacturing, and review and monitoring the quality systems.<o:p></o:p>

§  Developed plan for SOPs, protocols and other internal guidelines for various CGMP activities. <o:p></o:p>

§  Drove the efforts for reviewing investigation reports, calibration reports, qualification, validation and stability protocols, development reports, analytical method development and technology transfer protocols.<o:p></o:p>

§  Responsible for steering and setting up of new analytical lab independently.<o:p></o:p>

§  Ensuring the adherence and compliance to the QA audit checklist on daily basis, and in case of non-compliance focusing of its improvement.<o:p></o:p>

§  Involved in Review and approval of equipment qualification protocol and reports, area /facility qualification protocol and reports, utility qualification / requalification protocol & reports, Process and Cleaning Validation Protocol & Reports, Change control /Deviation, Risk assessment.<o:p></o:p>

§  Handling Preparation, Review and approval of APQR and Site Master File, Calibration / Validation schedule monitoring, review and Approval.<o:p></o:p>

§  Monitoring of CAPA and response preparation for regulatory queries.<o:p></o:p>

§  Investigating OOS / OOT / Incidents, review & approval of investigation report.<o:p></o:p>

§  Managing Line clearance for various manufacturing and packaging operations, Batch Release; ensuring the GMP compliance and control on the shop floor.<o:p></o:p>

§  Preparing SOPs and reviewing the same as per schedule. Ensuring the adherence and safety in the factory premises as per safety checklist and in event of non-compliance focusing on its improvement.<o:p></o:p>

§  Conducting Quality Assurance Capability Index (QACI) audit and monitoring the closing of issues along with diligently implementing statistical methodologies and quality tools to monitor and control quality; provided inputs into reports on the effectiveness and suitability of the management system.<o:p></o:p>

§  Proficiently impart training and seminars to related personnel as per their needs.<o:p></o:p>

§To complete internal audits to an agreed programme<o:p></o:p>

§Co-ordinate, monitor and complete external vendor audits to an agreed programme.<o:p></o:p>

§Track corrective and preventative actions from internal and external audits and where possible close out together with assisting other departments to close out.<o:p></o:p>

§Responsible for preparation of Vendor Audit Plan in coordination with purchase department.<o:p></o:p>

§Responsible for performing audit at RM /PM / Contract manufacturing vendor site. <o:p></o:p>

§Responsible for handling activities related to Vendor Approval<o:p></o:p>


Jul 2000Jun 2002


<html />