Data Center GxP Qualification SME

Experience

: 46 years of relevant experience in data center qualification, validation, or regulated infrastructure environments.

Job Summary

: The ideal candidate should have sufficient; preferably, 4-6 years experience in data center qualification and is responsible for planning executing and maintaining the qualification of data center facilities and supporting infrastructure in compliance with the GxP regulations and industry standards.

Key Responsibilities

• Lead, execute and report Data center Qualification activities
• should be able to identify critical data center systems and perform/support risk assessments in line with GAMP5
• Define Qualification scope
• Create/Review validation deliverables like URS, Validation plan, design documents, IQ/OQ/PQ, RTM, Validation Summary Report
• Support Go-Live activities
• Work closely with technical teams (Network, QA, Monitoring etc.) and support projects and upgrades as a validation SME
• Support Audits and inspections
  

Required Skills

• Strong understanding of data center and its operations
• Expertise in GxP relevant requirements in data center Qualification
• Hands on experience creating validation deliverables
• Strong understanding of GAMP5, 21 CFR Part 11, EU GMP Annex 11, Risk based validation approaches
• Excellent documentation and communication skills. Should be able to work independently and collaborate with multiple cross functional teams.
  

Education

• Bachelor's degree in Engineering, Life Sciences or related field.
• Relevant certification in Validation or Compliance is a plus.