Mode : Contract ( 3 Months with possible extension )
Years of experience: 7+ Years
Responsibilities
Minimum 7 years of experience in CSV in the Pharma industry.
Clear understanding of principle, procedures and governance of validation activities and IT controls
Deep Knowledge of regulations: 21 CFR Part 11 / 210/ 211 and Annex 11
knowledge 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, 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 on decommission, Archiving and Data Integrity (ALOCA+)
Experience in supporting Data Migrations from 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.