We are looking for people who have demonstrated proven success in roles and through abilities in Computerized System Validation/Computerized System Assurance, Risk Management, Test Management and Audits.

Below are the role expectations:

5 10 years of professional experience in the Life Sciences industry working for a consulting services organization and/or industry. Good understanding of key pharmaceutical compliance regulations like 21 CFR Part 11, GxP and GAMP 5. Experience creating, reviewing, and approving / acknowledging validation deliverables. Strong knowledge of Software Development Life Cycle (SDLC), testing methodologies, risk-based testing, requirement traceability, defect lifecycle management, and quality assurance processes, with the ability to analyze business and functional requirements and identify quality risks. Knowledge of risk management process and quality management requirements which assures that IT Projects meet Quality and Regulatory requirements. Experience in validation of Enterprise applications such as

SAP / S4 HANA

projects, Veeva, Trackwise, QMS, DMS, Laboratory applications like LIMS, MODA, manufacturing applications like SCADA, MES and etc. Functional knowledge in any of the domain applications such as Clinical applications like

EDC, CTMS

etc., Regulatory applications like CDR, or any other applications/system used in Pharma industry. Thorough Knowledge in compliance and validation concepts. (Change, Deviation, Supplier management) Experience in Agile and waterfall methodology Knowledge and hands on experience in conducting periodic or control maturity assessment and Audits Knowledge in Saas/Cloud Qualifications Knowledge of validation tools and templates used in the pharmaceutical industry.

Example:

Kneat, ServiceNow and Veeva. Proven ability in supporting multiple projects, responding quickly to changing situations in complex environments. Preferable IT background to understand complexities on the program.