Computer System validation
3 days ago
Greetings from HCL
Hiring for "Computer system validation"
Experience
- 8-20 Years
Location
- Bangalore / Noida / Chennai / Hyderabad / Pune
CTC
- Can be discussed
JD:
Computer System Validation Manager
Mandatory Skills CSV Manager, Compliance and Assurance services, LIFESCIENCES GXP FDA CSV IQOQPQ, Leading Offshore CSV Team to drive validation deliverables , Stake holder managementJD Primary Skill Computer System Validation Management, Computed system assurance, GAMP, GxP risk assessments, Change Management , Leading Offshore teamSecondary Skill JIRA Veeva Argus Agile and Waterfall methodology 15+ years in CSV for GxP applicationsStrong understanding of Agile and Waterfall methodologies in validation contextExperience with tools like ALM, DMS, JIRAAct as single point of contact for geospecific and functional validation scope.Lead endtoend validation lifecycle for GxP applications 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 minor and major 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 across regions.Build and maintain stakeholder relationships, manage feedback loops, and ensure alignment with business needs.Guide and mentor validation teams on daily activities and deliverables.Collaborate with crossfunctional teams to ensure timely and compliant system releases
Interested candidates please drop an email to ""
Regards,
Kushma
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