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Mukesh Gandhi Email Address

abcdefghij@purduepharma.com

Job Title

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

Company
Purdue Pharma

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

Bio

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

Last University
Attended Certified GCP Professional
Location
Based in Parsippany.

Other people working at Purdue Pharma:

Maria BartonGeneral Counsel and Chief Ethics and Compliance Officer
David RosenChemistry Lab Coordinator
Cindy LibonatiExec Director Corporate Procurement
Marylee SawkaDirector Enterprise Solutions
Tom MorrisseySenior Director of Legal Operations and EDiscovery
Greg DzurindaCyber Security Manager
David SaussyExecutive Director, Licensing and Business Development
Paul BrinckerhoffSenior Director
Karen LaurelVice President, Human Resources
John NarlisExecutive Director, Information Technology Enterprise Solutions
Jennifer LauriatCorporate Procurement Manager
Anthony SclafaniDirector, Head of Commercial Information Technology
Ellie He********@purduepharma.com
Phillip PerrySenior Quality Specialist III, Quality Improvement, Quality Auditing
George DavisSeeking Position As Maintenance Manager Or Supervisor
Jon LowneController
Sravanthi PolavarapuQuality Specialist III
Heather KrebsQuality Analyst
Sajjan DanielVice President, Head of Drug Safety and Pharmacovigilance
Neil Stinson**********@purduepharma.com
Jay ButlerAssociate Director, Industrial Engineering
Joseph Northington**********@purduepharma.com
Changhe WenSenior Manager and Senior Principal Scientist and Assistant Director
John AustinSenior Manager, Solution Delivery

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