Testing CSV demand Computer System Validation) Professionals

A Self driven and motivated leader with 12 to 18 years of experience in Computer System Validation (CSV) / Infrastructure Qualification, of which at least 4 years as Engagement Manager.

Experienced in leading and growing medium to large Engagements on Testing and Validation

Experienced in working directly with US / European clients and their IT Compliance / QA.

Experience must include full life cycle validation of GAMP Cat 4 and Cat 5 Systems / IT Infrastructure.

Good understanding of different SDLC methodologies, IT Service Management Processes and LS QMS Processes.

Ability to strategize, plan and oversee the validation of Computerized Systems.

Experienced in GXP Risks, 21 CFR 11, and Annex 11 (or ERES) Assessments.

Highly skilled and experienced in authoring / review of validation documentation such as URS, FRS, and SDS, Validation Plan, Training Plan, Issues Log, Design Review, IQ Protocol/Report, OQ Protocol/Report, PQ Protocol/Report, Test Cases, Test Incidents, Trace Matrix, and Validation report, etc.

Experienced in preparing and finalizing test impact assessment, estimates, strategy and plans

Expert author of validation test scripts (IQ/OQ), support creation of PQ (on business processes).

Good experience in Change control, CAPA and Deviation documentation, review and approval.

Excellent QA Review skills and experienced in guiding and providing feedback to multi-cultural / geographically different teams.

Good experience in working on automated testing and validation management tools like HP ALM, ValGenesis, Document Management Tools, etc.

Experienced in performing Periodic Reviews. Good understanding of GXPs and its requirements. Good understanding of global regulations and Health Authorities, Medical Devices Regulatory expectations governing computerized systems. 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. Must be experienced in Validation Estimation, Project Planning, Tracking and Reporting.

Ability to identify, analyze and mitigate validation project risks.

Excellent 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 training validation team members / client teams in global regulations and Validation SOPs.