System Validation Engineer

We are looking for people who have demonstrated proven success in roles and through abilities in Computerized System Validation/Computerized System Assurance, Risk Management, Test Management and Audits.

Below are the role expectations:

• 5 – 10 years of professional experience in the Life Sciences industry working for a consulting services organization and/or industry.
• Good understanding of key pharmaceutical compliance regulations like 21 CFR Part 11, GxP and GAMP 5.
• Experience creating, reviewing, and approving / acknowledging validation deliverables.
• Strong knowledge of Software Development Life Cycle (SDLC), testing methodologies, risk-based testing, requirement traceability, defect lifecycle management, and quality assurance processes, with the ability to analyze business and functional requirements and identify quality risks.
• Knowledge of risk management process and quality management requirements which assures that IT Projects meet Quality and Regulatory requirements.
• Experience in validation of Enterprise applications such as SAP / S4 HANA projects, Veeva, Trackwise, QMS, DMS, Laboratory applications like LIMS, MODA, manufacturing applications like SCADA, MES and etc.
• Functional knowledge in any of the domain applications such as Clinical applications like EDC, CTMS etc., Regulatory applications like CDR, or any other applications/system used in Pharma industry.
• Thorough Knowledge in compliance and validation concepts. (Change, Deviation, Supplier management)
• Experience in Agile and waterfall methodology
• Knowledge and hands on experience in conducting periodic or control maturity assessment and Audits
• Knowledge in Saas/Cloud Qualifications
• Knowledge of validation tools and templates used in the pharmaceutical industry. Example: Kneat, ServiceNow and Veeva.
• Proven ability in supporting multiple projects, responding quickly to changing situations in complex environments.

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