• A proactive and motivated person with minimum 2+ years of experience in Computer System Validation (CSV) / Infrastructure Qualification as Validation Manager / Qualification Manager. A strong IT background is prefered. Experience in leading medium to large compliance / validation program.
• Experienced in working directly with US / European clients and their IT Compliance / QA.
• Good understanding of different SDLC methodologies, IT Service Management Processes and LS QMS Processes.
• Experienced QA reviewer of CSV documentation, can monitor and guide the teams to meet the client expectations. Experienced in providing feedback to multi-cultural / geographically different teams.
• Experienced in automation testing, and validation management tools like HP ALM, ValGenesis, and Document Management Tools.
• Experienced in validating GXP, 21 CFR 11, and Annex 11 (or ERES) requirements; Periodic Reviews; able to guide validation and complaince Managers / leads, oversee the project progress.
• Expeienced in metrics and tracking KPI at a program level.
• Good experience in Change control, CAPA and Deviation documentation, review and approval.
• Must be experienced in supporting CSV Audits / Regulatory Inspections.
• Experienced in managing Validation and Testing Teams of at least 20 members. PMP Certification is an advantage. Expeienced in demand management, program management, financial, risk, and escalation management.
• Exceptional English communication and interpersonal skills. French proficiency is a real advantage. Comfortable and professional engagement with senior leadership, Client Managers, and multi-location teams. Be diplomatic and have good negotiation skills.
• Ability / Experience in guding teams / training validation on SOPs.