Senthilkumar Munusamy Email & Phone Number

Chennai Area, India

Responsible for QMS, Audit & Compliance, Training & Development.Monitoring Data integrity in empower systems & Stand alone systems (Non-Empower).

Chennai Area, India

Vishakhapatnam Area, India

QMS sytems. Change control, OOS & OOT investigations.Quality control documents approvalData integrity - 21 CFR Part 11 compliance.Process validationsCustomer complaintsInternal Audit

Chennai

• Review and approval of site related SOPs.• Review and approval of batch failures and their associated investigations, Annual Product Quality Review(APQR) .Handling of dispatch related activities through SAP system..• Ensure cGMP compliance of manufacturing facilities for up gradation of the quality system. • Review and ensure compliance of Analytical method validations, analytical method transfer documents. • Technical Training to subordinates on cGMP and cGLP as per regulatory guidelines.• Conducting Cross functional audits (Self-Inspection) for quality system Improvement and compliance.• Assisting in the preparation for regulatory and customer audits by required documents and answer the auditors during regulatory audits like USFDA, MHRA etc & customer audits for successful completion. • Conducting failure investigation and impact assessment.• Compilation of regulatory audit findings and ensuring compliance status. Responding to queries from regulatory authorities.• Coordination in submission of quality documents for Regulatory Filing.• Review and ensure stability protocol and stability data of exhibit and commercial batches. Review and approval of stability data & trending.• Review and approval of Batch production record & batch packing records.• Monitoring and strengthening of analytical research development & quality control laboratory practices and its continuous compliance.• Review and ensure that all drug products (exhibit & commercial batches), Stability samples, Raw and Packaging materials are tested under strict cGMP conditions.• Monitoring and ensuring the data integrities (21 CFR Part 11 compliance) in Quality control lab and Analytical development laboratories.• Review and approval of all works is performed in compliance with SOPs, GMPs, GLPs, regulatory requirements and established safety standards..