Moorthy

About Moorthy

Quality Assurance professional with 20+ years of progressive experience in…

Experience

1. Quality Assurance Manager

   Aurobindo Pharma Ltd

   Sep 2016 — Present

   Currently Handling@ Aurobindo Pharma – Section in Charge (Team Size: 36)· QMS – Internal Audits and Compliance-• Arrange documents for scheduled audits (Customer / Regulatory inspections ).• Conducts internal and external audits for stakeholder facilities and IT systems.• Ensures compliance with Global CAPAs,• Review and approval of Quality Notifications (Change Controls, PNC, Exceptions, QRM)• Schedules and coordinate for conducting MRMs with Management teams.• Prepares for site inspections (Customer & Regulatory).• Follows up on audit responses and approves corrective and preventive actions.• Transforms observations from audits and extends audit scope to other Sites compliance.• Involved in Quality Improvements Projects and coordinates enhancements with upgraded requirements.· Training Management and Compliance Overview -• Conducting training sessions for new employees and contract workers.• Establishing and revising learning curriculum in line with cGMP guidelines.• Monitoring compliance to Learn IQ / Nichelon Software across formulation sites.• Identifying training needs and developing training modules.• Implementing technical training through Training Management Systems(LMS)• Coordination with corporate and external parties for need-based trainings.• Imparting training on ALCOA++, GMP and ensuring assessments to overall the Plant.• Administrator for IT enabler- LMS System for site compliance.• Conducting audit trails in the software.• Designs, develops & manages Standard Operating Procedure for Technical Training function.· Documentation Management and Compliance:• Harmonizing procedures and practices across sites.• Reviewing and evaluating change controls and impact assessments.• Approving Master Documents, Product Quality Reports, and Retention period documents.• Conducting GAP Assessments in DMS System and its compliance.• Review of Batch records and its compliance.• Review of Process Non-Conformances, Market Complaints and I

Education

• BII

  Master's Degree

• NIBM Institute

  Master of Business Administration

• Acharya Nagarjuna University

  Master of Science

• S.V. University

  Bachelor of Science