CQA-HEAD- HANDLING MULTIPLE SITES- HARMONIZATION OF SYSTEMS, PROCEDURES AND PRACTICES., TRAINING IMPARTATION OF QC/QA, SITE readiness for audit and compliance.Internal audit verification, conduct Quality Review Meeting.

Corporate quality functions - Quality review - ensure Site readiness for audit - conduct Quality Review Meeting - implementation of procedures - training and development - Harmonization of SOP' and practices - GMP compliance - QC Data Integrity review - Investigation and compliance - implementation of automation systems. Periodical visit of Multiple sites to ensure Quality elements and QC systems GMP compliance.

V. BASKAR Cell : +91-9652885217 +91-9652885283E mail: baskar_69@rediffmail.com v.baskar_69@yahoo.com Career Profile : GENERAL MANAGER –CORPORATE-QAMaster Degree in “ANALYTICAL CHEMISTRY” specialization has been awarded by A.C.College and Tech, University of Madras, Professionally working as GM-CORPORATE QA with multiple Sites of manufacturing facilities, hands on experience is more than Twenty Three Years in the filed of API/FORMULATION Analytical Research and Development (ADL), Quality Control, Quality Assurance, Regulatory Affairs and Corporate QA. Possess good communication, motivating teams to achieve their objectives, analytical design and problem solving skills. Core competencies: • Multiple Sites Handling Capability.• Site readiness for audit/ GMP Compliances• Harmonization and implementation of Guidelines and Systems.• Effectiveness of CAPA Management Review on Periodic intervals• Review Mechanism with Six Quality Compliances as per USFDA.• Review Mechanism with Risk Based Approach• Review Mechanism with QBD Approach• Excellent management and descision making skills• Performed compliance audits and ensuring CMC (Chemistry Manufacturing Control)• Audit facing and compliance with several regulatory/customers. • Worked with different MNC companies (Piramal Enterprises/Shasun Chemicals/Embio/Eucare/Asian Peroxides/Wanbury)• Participation in Management Review Meeting updating Critical GMP issues and find out solution to problembs.

Professional Experience: 1) Previous employer : Wanbury Limited (accredited by USFDA, EDQM,,WHO-GMP), three facilities at AndraPradesh and MadyaPradesh– Engaged in the manufacturing API & New Chemical Entities – GM Corporate -QA since Dec 2014 to till date.2) Previous Employer : Embio Limited (accredited by USFDA,TGA,KFDA,PMDA,EU-COS,WHO-GMP), Mahad, Raigad District – Engaged in the manufacturing API & New Chemical Entities - Working since March 2011 to Nov 2014 as Head Corporate Quality Assurance & Regulatory Affairs – Team Size Handling – QC 60, QA 15, RA 5, Total 80, Reporting to Managing Director.3) Previous Employer : Eucare Pharmaceuticals Limited, Chennai (accredited by ISO 9001-2008 and WHO-GMP) Engaged in the manufacturing API worked since April 2010 to February 2011, as Head Quality Control and Quality Assurance Manager – Team Size Handling – QC 40, QA 15, Total 55, Reporting to Managing Director.4) Previous Employer : Piramal Health Care(accredited by USFDA, Iso 9001-2008, WHO-GMP) , Ennore, Chennai engaged in API/Formulation – Worked as Quality Control and Quality Assurance Manager) during period August 2003 to April 2010 –Team Size Handled : 50. 5) Previous Employer : Shasun Chemicals and Drugs Limited, Research and Development – Velacherry – API manufacturing Pondy – USFDA unit, ISO 9001-2008, WHO GMP – Worked as Assistant Manager Quality Control – during the period August 1996 to July 2003.6) Previous Employer : M/s Asian Peroxies Limited, Sullurpet, Nellore District, Worked as Quality Assurance Supervior – during the period December 1993 to July 1996.