Role: Validation Lead Manager
Location EAST COAST
Proactive and motivated person with minimum 3 to 10 + years of experience in Computer System Validation (CSV) in GxP and Non-GXP systems like General Information Systems / Infrastructure Qualification / Laboratory System / SAPS Systems , of which at least 6+ years of exp as Validation Lead / Validation Manager / Qualification Manager role. Experience must include full life cycle validation of GAMP Cat 4 and Cat 5 Systems / IT Infrastructure Qualification.
• Experienced in working directly with US / European clients and their IT Compliance /QA.
• Good understanding of different SDLC methodologies, IT Service Management Processes and LS QMS Processes.
• Ability to strategize, plan and oversee the validation of Computerized Systems.
• Experienced in GXP Risks, 21 CFR 11, and Annex 11 (or ERES) Assessments.
• Highly skilled and experienced in authoring / review of validation documentation such as URS, FRS, and DS, Validation Plan, Training Plan,
Issues Log, Design Review, IQ Protocol/Report, OQ Protocol/Report, PQ Protocol/Report, Test Scripts, Traceability Matrix, and Validation Report, etc.
• Experienced in preparing and finalizing test impact assessment, estimates, strategy and plans.
• Expert author or support of validation test scripts (IQ/OQ), support creation of PQ (on business processes).
• Good experience in Change Control, CAPA and Deviation documentation, review and approval.
• Excellent QA Review skills and experienced in guiding and providing feedback to multi-cultural / geographically different teams.
• Good experience in working on automated testing and validation management tools like HP ALM, JIRA, ValGenesis, Document Management Tools, etc.
• Experienced in performing Periodic Reviews Good understanding of GXPs and its requirements.
•Good understanding of global regulations and Health Authorities, Medical Devices Regulatory expectations governing computerized systems. Must be experienced in supporting CSV Audits / Regulatory Inspections.
•Experienced in managing Validation and Testing Teams of at least 10 members. Must be experienced in Validation Estimation, Project Planning, Tracking and Reporting.
• Ability to identify, analyze and mitigate validation project risks.
• Excellent English communication and interpersonal skills.
Bhaskar kumar Koppisetti
Email :kumar.koppisetti@3sbc.com
Hangout : bhaskarkumar3sbc@gmail.com
An E-Verified Company
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