Minimum 5 years of experience in CSV in the Pharma industry.

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

Deep knowledge of regulations: 21 CFR Part 11 / 210/ 211 and Annex 11.

Knowledge of how to get the CSV validation compliance done based on already identified gaps.

Understanding of quality risk-management concepts (ICH Q9).

Experience in systems validation and quality frameworks.

Perform quality review of relevant validation documentation pre and post-execution for accuracy, and completeness and ensure compliance with regulatory and client requirements.

Experience in executing change control and document management.

Strong knowledge of GAMP5 and Quality Systems.

Experience in decommissioning, Archiving, and Data Integrity (ALOCA+).

Experience in supporting Data Migrations from a validation perspective.

Ability to communicate and work independently with technical teams.

Adept with Agile and Waterfall methodology-based software development and has prior experience in computer system validation using agile methodology.