Computerized Systems Validation Analyst

About the job

The role of the CSV is to establish quality validation packages for the GxP computerized systems used at Innovaderm with the goal of ensuring data integrity and compliance with the regulatory and industry requirements.

More specifically, CSV Analyst:

• Establishes computerized system validation schedule for key deliverables with the system owners and functional departments.
• Determines the extent of system validation based on the policy, standard operating procedures (SOPs), system type and risk-assessment.
• Leads the development and/or review of the validation packages including but not limited to Validation Plan, user requirement specification (URS), ERES Assessment, System risk assessment, functional and configuration specifications, test scripts (IQ/OQ/PQ), data migration verification, traceability matrix, validation summary report.
• Assesses the completeness of vendor validation packages to determine if it can be leveraged to support validation of computerized systems at Innovaderm.
• Leads post-implementation validation activities for the lifecycle of GxP Computerized systems (including but not limited to Change Control Management, CAPA, Periodic Review, Internal and External Audit Support, Verification of Data Migration/Data Back up/Archival, System Retirement)
• Provide support and guidance to the system owners/system administrators for their responsibilities for the management of computerized systems (e.g., periodic review).
• Can participate to the establishment/review of SOPs and process improvement initiatives.
• Contribute to training content related to the computerized systems aspects.
• Provides solutions to a wide range of problems through individual efforts in a creative, thorough, practical, and consistent fashion in line with applicable regulations
• Provides support, if required, to QA team during vendor qualification, internal and external audit processes.

Requirements:

IDEAL PROFILE

Education

• Bachelors degree in computer science, engineering life science or related field.
• Equivalent experience and/or will be also considered.

Experience

• Minimum of 5 years of experience in Computerized Systems validation in the GxP industry; prior experience with clinical platforms is an asset (e.g., IWRS, EDC, ePRO/eCOA, eConsent).
• Knowledge And Skills
• Excellent knowledge of regulations and guidelines related to computerized systems validation (US FDA 21 CFR part11, EU annexe 11, Health Canada, GDPR, ICH.
• Strong technical knowledge to provide concise and clear documentation, verbal communication, interpersonal and problem-solving skills.
• Ability to work independently.
• Good knowledge of the Microsoft Office Suite (Word, Excel, PowerPoint) and other tools used in CSV (e.g., JIRA, HPALM, DMS).
• Good organization skills and ability to adapt to a rapidly growing environment.
• English, written and spoken.
• Experience in writing reviewing SOPs for accuracy and GxP compliance.
• Organizational abilities to meet accelerated timelines, manage multiple shifting priorities and maximize efficiencies in a dynamic customer-focused environment.
• Superior attention to details.
• Critical-thinking and problem-solving skills; ability to recognize and resolve discrepancies and issues.

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