Job Description

Responsibilities:

• Creates Computer System Validation (CSV) deliverables (Validation Plan, Requirements Specifications, Protocols, Summary Reports, Trace Matrices, SOPs, Risk assessments).
• Collaborates with Business Users, System Owner, Global IT teams and Business Analysts to define validation requirements and plans.
• Providing leadership, oversight, and training related to validation activities to multi-functional teams.
• Generate and execute validation protocols (IQ/OQ/PQ) using Good Documentation Practices (GDP).
• Ensuring that the quality system elements necessary to achieve and maintain compliance across multiple businesses, including regulated environments, are established and activities related to computer systems/software testing are controlled via these elements.
• Working with appropriate teams to establish quality expectations related to validation planning and execution.
• Participating with stakeholders in the preparation of software specification documents, risk management and validation plans.
• Participating in developing qualification processes and implementing standard operating procedures.
• Participate in execution of gap assessment and remediation activities.
• Investigate and resolve exceptions, non-conformances, deviations, CAPAs and change controls related to validation protocols.
• Authoring, reviewing, and/or approving system change, configuration management and supporting documentation activities.
• Preparing for and participating in external/internal computer system/software audits.
• Serve as the SME for CSV activities and maintain knowledge and information in the CSV area of expertise.
• Contributing to process improvements by developing and updating written procedures related to computer systems.

Requirements:

• Bachelor's/master's degree in computer science engineering or equivalent.
• At least 10 years of experience in Computer System Validation role in the pharmaceutical, biotech, medical device, or other regulated industry.
• Demonstrated experience in software quality assurance processes, SDLC methodology, change management, documentation, verification, and validation techniques.
• Understanding of GAMP 5 techniques and software industry standards and their impact on internal procedures, and software quality.
• Demonstrated project management and leadership skills.
• Proficiency in interacting with contacts, including project teams and vendors.
• Certified auditor or equivalent experience conducting software-vendor quality audits.
• Working knowledge of the FDA Quality System Regulation, 21 CFR Part 11, EU GMP, Annex 11 and the European and Canadian Medical Device Directives.
• Understanding of current software quality techniques and industry standards such as ISO, ASQ, AAMI, and GAMP.
• Quality Management System.
• Document Management System.
• Validation Management System.

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