Computer System Validation

Identify and manage regulatory risks to support client in regulatory compliance, governance and controls

Lead and coordinate cross-functional project teams for new product development and other validation projects to include reviews, risk analysis and other QA activities in support of systems development and manufacture

Assist client in developing strategies for process improvement which caters to the needs of the quality organization

Author validation strategies and other plans/protocols and summary reports (end-to-end computerized system validation experience is mandatory)

Coordinate and interface with R&D, Engineering, Software Development, IT, Manufacturing and Quality Assurance groups to assure successful project execution and end-user training

Plan, manage and execute as needed, installation, operational and performance qualifications in accordance with current Good Manufacturing Practices (cGMPs)

Review and approve validation lifecycle documentation

Review and identify validation deviations and resolve deviations with appropriate corrective/preventive actions

Provide Quality review and assessment of associated change requests related to processes, IT infrastructure, equipment's and computer systemsManage project governance, including providing progress updates of the assigned deliverables, driving timely closures of escalations and facilitating strategic decisions with senior management.

Initiate trainings and workshops for knowledge transfer and competence building

Qualifications and experience Required:

Bachelor's degree (or equivalent)

2 -5 years of experience in pharma or medical device industry with a focus on quality and regulatory compliance

Experience in systems validation and quality frameworks

Hands on knowledge of software lifecycle approaches (GAMP5, Agile, Waterfall)Hands on project management skills managing medium to large projects with end-to-end validation experience

Clear understanding of principles, procedures and governance of validation activities.