Computer System Validation Lead

3 days ago

Hyderabad, Telangana, India beBeevalidation Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

System Validation Leadership

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Job Description:

Our organization is seeking an experienced Computer System Validation Manager to oversee the validation lifecycle for GxP applications.

Key Responsibilities:

  • Lead end-to-end validation activities, including planning, execution, and reporting.
  • Author and review validation deliverables: URS, FRS, Risk Assessments, Test Protocols, RTMs, Validation Plans, and Summary Reports.
  • Ensure traceability and completeness of test cases aligned with risk levels.
  • Oversee defect management and ensure proper documentation of test results and evidence.
  • Manage change control processes for system updates.
  • Review and approve operational procedures and SOPs for validated systems.
  • Perform CSL roles including CSA, Validation SME, and Test Manager as per CSL QMS.
  • Drive service quality, performance, and customer satisfaction.
  • Build stakeholder relationships and ensure alignment with business needs.
  • Guide and mentor validation teams on daily activities and deliverables.
  • Collaborate with cross-functional teams to ensure timely system releases.

 

Required Skills and Qualifications:

  • 15+ years in CSV for GxP applications.
  • Strong understanding of Agile and Waterfall methodologies.
  • Experience with tools like ALM, DMS, JIRA.
  • Mandatory skills: CSV Manager, Compliance and Assurance services, LIFESCIENCES GXP FDA CSV IQOQPQ.

 

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