Mukesh Gandhi Email Address

Senior Manager and Senior Quality Specialist III: GMP, GCP, and Computer Systems Auditing, and Computer Systems Validation

Purdue Pharma is committed to advancing the medical care of patients with quality pharmaceutical products.

SUMMARY:A successful Senior Quality Assurance professional with over 15 years of hands on experience in the Pharmaceutical Industry for GMP, GCP, and Computer Systems auditing, and Computer System Validation (CSV). Thorough understanding of GMP and GCP regulations, Part 11 Compliance, and Data Integrity. Possesses excellent people and communication skills with the ability to motivate, gain cooperation, and influence the decision-making and cost saving efforts. Excellent ability to support Regulatory Agency / FDA Inspections, and manage mock-audits for FDA Readiness activities. Specialties: GMP Auditing- API and Excipient Suppliers, Packaging Component Suppliers, Distribution Warehouse, Calibration and Qualification Service Providers GCP Auditing- CROs, Clinical Operation sites, Central Labs, Clinical Suppliers, IxRS providers Computer Systems Auditing- IT Systems / Application Software Suppliers and IT Data Centers Computer Systems Validation Data Integrity CAPA Program Management Risk based approach to maintain high level of Quality and Compliance Support regulatory inspections Regulations: 21 CFR Part 50, 56, 312 & 314 (GCP) ICH GCP Guideline (E6) 21 CFR Part 11 for Electronic Records: Electronic Signatures – Risk Based Approach Annex 11: Computerized Systems 21 CFR Part 210 & 211 (GMP) 21 CFR Part 58 (GLP) GAMP 5 A Risk-Based Approach to Compliant GxP Computerized Systems