Jayaanth J Varandani

Work History

Work History

Head Quality Assurance

RASAN PHARMACEUTICAL
SOLUTION, SULAMANI(IRAQ) Mar' 13- Head Quality Assurance 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. Oversee to ensure that all the components of a complete, acceptable QC and QA program are in place. Deftly implemented current Good Manufacturing Practices and GLPs in drug product laboratories, custom manufacturing, and review and monitoring the quality systems. Developed plan for SOPs, protocols and other internal guidelines for various CGMP activities. Drove the efforts for reviewing investigation reports, calibration reports, qualification, validation and stability protocols, development reports, analytical method development and technology transfer protocols. Responsible for steering and setting up of new analytical lab independently. Ensuring the adherence and compliance to the QA audit checklist on daily basis, and in case of non- compliance focusing of its improvement. 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. Handling Preparation, Review and approval of APQR and Site Master File, Calibration/Validation schedule monitoring, review and Approval. Page1 of4 Monitoring of CAPA and response preparation for regulatory queries. Investigating OOS/OOT/Incidents, review & approval of investigation report. Managing Line clearance for various manufacturing and packaging operations, Batch Release; ensuring the GMP compliance and control on the shop floor. 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. 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. Proficiently impart training and seminars to related personnel as per their needs. To complete internal audits to an agreed programme Co-ordinate, monitor and complete external
Jan 2011 - Dec 2012

Quality Assurance

UNICHEM LABORATORIES LIMITED
INDORE, INDIA In-charge Quality Assurance 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. Oversee to ensure that all the components of a complete, acceptable QC and QA program are in place. Deftly implemented current Good Manufacturing Practices and GLPs in drug product laboratories, custom manufacturing, and review and monitoring the quality systems. Developed plan for SOPs, protocols and other internal guidelines for various CGMP activities. Drove the efforts for reviewing investigation reports, calibration reports, qualification, validation and stability protocols, development reports, analytical method development and technology transfer protocols. Responsible for steering and setting up of new analytical lab independently. Ensuring the adherence and compliance to the QA audit checklist on daily basis, and in case of non- compliance focusing of its improvement. 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. Handling Preparation, Review and approval of APQR and Site Master File, Calibration/Validation schedule monitoring, review and Approval. Monitoring of CAPA and response preparation for regulatory queries. Investigating OOS/OOT/Incidents, review & approval of investigation report. Managing Line clearance for various manufacturing and packaging operations, Batch Release; ensuring the GMP compliance and control on the shop floor. 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. Page2 of 4 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. Proficiently impart training and seminars to related personnel as per their needs. To complete internal audits to an agreed programme Co-ordinate, monitor and complete external vendor audits
Apr 2008 - Dec 2010

Assistant Manager Quality Assurance

MEDLEY PHARMACEUTICAL
DAMAN, INDIA Assistant Manager Quality Assurance Reporting to senior management(GM-Quality Assurance) about non-compliance and responsible for preparing corrective action and preventive action to handle them methodically. Responsible for Overall co-ordination to build up and maintain QA system in the plant. Pre-requisite validations/exhibit batches planned for regulated market and post approval commercial launch in conjunction with process validations. Evaluation and approval of Change controls, Deviation Controls, Incident, OOS, CAPA & non-conformances. Product Quality Review, Conducting self-inspections, Investigate, and response of market/customer Complaints. Review and approval of process validation & cleaning validation and equipment qualification, HVAC system and water system. Review, approval and implement critical Quality documents like, VMP, SMF, Validation & Qualification protocols/reports Quality Manual, Layouts, SOPs, Specification, Test method and Batch records equipment calibration records & Stability data. To co-ordinate during Quality audits by various customer & regulatory agencies and supervise submission its compliances. To impart on job GMP training to production, QC, Engineering and Warehouse personnel. To carry out vendor audit in order to develop new vendor,(Quality system Audit in API and primary packing materials manufacturing plant). Budget-project and control of expenses of QA. Applying, renewal or withdrawal of manufacturing licenses, notifying changes purposed and made in the facility/formulation, application on different form. To send management information report on monthly basis. Collaborate with other departments to ensure timely delivery & implementation of GMP practices. To work closely with upper management to ensure that key strategic quality objectives are met. Controls and coordinates the disposition of Quality systems. Page3 of 4
May 2006 - Mar 2008

Senior Officer Quality Assurance

RANBAXY LABORATORIES LIMITED
DEWAS, INDIA Senior Officer Quality Assurance To carry out in-process quality assurance checks during batch manufacturing and packing. To ensure and maintain Good Manufacturing Practices in the manufacturing plant. Online review of Batch Production Records and IPQA records. To carry out sampling of rinse water, in-process samples, finished product samples, retain sample, registration samples, stability samples, micro samples, validation samples and other samples based on the requirement. To ensure CAPA and deviation against the Non Conformance. To ensure and verify RM and PM dispensing Review of raw data sheet and certificate of analysis of finished products To ensure continuous system improvement by reviewing documents and carries out self-audits of various departments in the plant. Preparation, review of SOP's, Master Batch records and Protocols To execute and review of process validation of products and compilation of validation data Review and compilation of all raw data required in preparation of qualification/validation report. Preparation and execution of qualification protocols of equipment in coordination with production, stores, and engineering. Checking of report from the analyst against standards and submission of inspected reports. To ensure adequate Identification and segregation of test samples to avoid mix up and cross contamination. Responsible for actual sampling and testing procedures. The actual sampling and testing of starting materials, intermediate products and finished products is done to verify that they meet the specifications before release for further manufacture or sale. It includes on-line quality control, intermediate and in- process controls using production staff. Provides technical support and training to Quality Control staff. The inspection, investigation, and analysis of samples, in order to monitor quality of the product.
Jul 2002 - Apr 2006

Officer Quality Assurance & Quality Control Chemist

ARISTO PHARMA, MANDIDEEP
BHOPAL, INDIA Officer Quality Assurance & Quality Control Chemist

Education

Education
2002

M.Sc

Barkatullah University
1976 - 2000

B.Sc

Barkatullah University