Udhaya Kumar Palanisamy

Work History

Work History

Sr. QA Executive

Confidential

ü  Review and Verify Production Batch Records <?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /><o:p></o:p>

ü  Review Validation Protocols<o:p></o:p>

ü  IQ, OQ, PQ<o:p></o:p>

ü  Review and Number Change Control(CC) and Maintain Log of CC<o:p></o:p>

ü  System Identification and Process implementation<o:p></o:p>

ü  Compliance Monitoring, Audits and CAPA<o:p></o:p>

ü  QA documentation <o:p></o:p>

Sep 2011 - Sep 2010

Test Lead - Life Sciences

Indium Software India Ltd
Sep 2011 - Sep 2010

Test Lead - Life Sciences

Indium Software India Ltd

ü  Verification & Validation – LIMS, CSV under GxP environment<?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /><o:p></o:p>

ü  Prepare and execute Master Validation Plan, <o:p></o:p>

ü  IQ, OQ, PQ<o:p></o:p>

ü  Assess 21 CFR Part 11 & Compliance Check<o:p></o:p>

ü  Plan and Perform Risk Analysis and it’s Mitigation<o:p></o:p>

ü  Trainer<o:p></o:p>

Sep 2011 - Sep 2010

Test Lead - Life Sciences

Indium Software India Ltd

ü  Verification & Validation – LIMS, CSV under GxP environment<?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /><o:p></o:p>

ü  Prepare and execute Master Validation Plan, <o:p></o:p>

ü  IQ, OQ, PQ<o:p></o:p>

ü  Assess 21 CFR Part 11 & Compliance Check<o:p></o:p>

ü  Plan and Perform Risk Analysis and it’s Mitigation<o:p></o:p>

ü  Trainer<o:p></o:p>

Sep 2011 - Sep 2010

Test Lead - Life Sciences

Indium Software India Ltd

ü  Verification & Validation – LIMS, CSV under GxP environment<?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /><o:p></o:p>

ü  Prepare and execute Master Validation Plan, <o:p></o:p>

ü  IQ, OQ, PQ<o:p></o:p>

ü  Assess 21 CFR Part 11 & Compliance Check<o:p></o:p>

ü  Plan and Perform Risk Analysis and it’s Mitigation<o:p></o:p>

ü  Trainer<o:p></o:p>

Sep 2011 - Sep 2010

Test Lead - Life Sciences

Indium Software India Ltd

ü  Verification & Validation – LIMS, CSV under GxP environment<?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /><o:p></o:p>

ü  Prepare and execute Master Validation Plan, <o:p></o:p>

ü  IQ, OQ, PQ<o:p></o:p>

ü  Assess 21 CFR Part 11 & Compliance Check<o:p></o:p>

ü  Plan and Perform Risk Analysis and it’s Mitigation<o:p></o:p>

ü  Trainer<o:p></o:p>

Education

Education
Jun 2004 - Jun 2006

M. Tech

VIT University