Infrastructure Qualification Specialist

1 week ago


Chennai, India Mazo Solutions Full time
Job Summary:

We are seeking an experienced Infrastructure Qualification Specialist with 10+ years of experience in qualification and validation processes for laboratory and manufacturing computerized systems in regulated environments. The ideal candidate will have a deep understanding of GxP compliance , IT infrastructure qualification, and lifecycle management, with proven expertise in handling complex projects in the life sciences, pharmaceutical, or medical device industries . This role demands strong technical, organizational, and communication skills to ensure compliance and support IT infrastructure in a GxP environment .

Key Responsibilities:
  • Execute Computer System Validation (CSV) activities for laboratory and manufacturing computerized systems.
  • Design and develop qualification plans, including deliverables, user requirements, and functional specifications for GxP-relevant infrastructure components.
  • Prepare test cases and scripts to verify qualification after changes to infrastructure components.
  • Create walkthrough narratives and process flow diagrams to identify key GMP controls and processing risks.
  • Execute qualification protocols, document deviations, and recommend resolutions.
  • Assess and qualify cloud infrastructure services supporting GxP applications.
  • Coordinate and execute infrastructure component/platform test execution efforts.
  • Conduct Quality Control reviews of qualification activities and deliverables.
  • Maintain compliance with 21 CFR Part 11, EU Annex 11, and GAMP5 regulations.
  • Collaborate with system owners, technical representatives, and business owners to ensure compliance and quality.
  • Develop and implement continuous improvement strategies for qualification processes.
  • Provide objective evidence of qualification and proactively notify stakeholders of issues.
  • Perform other duties as assigned by management.
Qualifications:

Experience:

  • 10+ years of experience in qualification and validation writing and execution.
  • Strong expertise in IT compliance for life sciences/pharmaceutical/medical device industries.
  • 4+ years of experience in Change Management processes related to IT infrastructure.
  • In-depth experience qualifying cloud services (SaaS, PaaS, IaaS) and supporting GxP applications.
  • Hands-on experience with SOC 2 reports, CUEC, and IT controls management.

Skills:

  • Comprehensive knowledge of qualification and validation processes in a GxP environment.
  • Proficient in AWS Cloud services qualification, SAP ECC, and OpenText ALM.
  • Familiarity with ServiceNow Change Management processes.
  • Solid understanding of requirement specifications, system design, and testing methodologies.
  • Effective communication skills for engaging stakeholders across various teams.
  • Strong project management and organizational skills.




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