IT Validation Professional

At Roche, compliance is our license to operate, and we are committed to delivering high-quality products. Every contribution you make will impact patients, as patient safety is at the forefront of everything we do. As a Senior IT Validation Professional, you will play a pivotal role in ensuring the quality of the products we deliver. You will be responsible for the evaluation, design, development, and approval of qualification deliverables, validation plans, protocols, and reports for computerized systems across various domains and product lines., * Validation / Qualification Strategy: Determine validation approaches and identify deliverables needed or impacted by projects, enhancements, or changes for GxP computerized systems.

• Documentation Review and Development: Review system documentation in accordance with Roche CSV SOPs and regulatory guidance. Develop and approve validation plans and reports; develop and approve qualification plans and reports; review and authorize test plans and reports, ensuring the system is ready to go live.
• Testing and Consultancy: Verify testing plans, activities, deliverables, and records. Provide consultancy on test-related deviations and corrective actions as per approved procedures.
• Deviation and Root Cause Analysis: Support investigations into deviations, identifying root causes, and defining corrective and preventive actions.
• Audit and Inspection Preparation: Act as a subject matter expert in CSV for system audit/inspection preparation and execution.
• System Maintenance: Ensure the validated state of systems is maintained, keeping them audit and inspection ready.
• Periodic Reviews: Lead and support system periodic reviews in accordance with company procedures.
• Continuous Improvement: Implement relevant frameworks and processes, propose and utilize tools, and prepare recommendations for process optimization.
• Training and Knowledge Sharing: Provide training and exchange validation/quality knowledge and experience.

Education: Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field.

Experience: Minimum 6+ years of experience in IT & Software Validation (CSV/CSA, GAMP) in pharma environment including:

• Leading validation / qualification for projects and system maintenance.
• Authoring qualification deliverables, validation plans, reports, and deliverable registries.
• Reviewing validation and testing-related deliverables, records, and other evidence, including relevant system documentation.
• Maintaining and supporting applications under global audit and inspection agencies.

Regulatory Knowledge: Very good knowledge of CSV regulations/guidance (e.g., CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices).

Tools: Experience in working with EDMS (i.e Veeva) and with ALM Tools (like ServiceNow, JIRA, or similar)

Risk Assessment: Strong expertise in system and data risk assessment.

Agile Methodology: Good understanding of Agile Methodology (Frameworks such as SAFe, Scrum); previous experience is an advantage.

Collaboration: Ability to work collaboratively in multiple cross-functional and agile teams to achieve milestones and goals.

Communication: Effective communicator with excellent verbal and written communication skills; proficiency in English is mandatory. Ability to communicate the relevance and detailed requirements of validation and qualification to non-experts.

Leadership and Soft Skills: Assertiveness, conflict management skills, leadership skills, and ability to work with diverse personalities and cultures.