What are the responsibilities and job description for the Computer Systems Validation Engineer position at Katalyst Healthcares & Life Sciences?
Job Description
Job Description
Responsibilities :
- Resolution of fundamental Computer System Validation compliance issues on assigned projects.
- Writing, reviewing, and executing computer validation documentation.
- Perform computer system validation activities related to process control systems of pharmaceutical water for injection system, water pretreatment system, water stills and high-quality steam generation systems.
- Validation of computerized systems, in accordance with GAMP5 and V-Model (USR, Function Specification, IQ / OQ / Protocol / Report / Testing, Traceability Matrix, Validation Report).
- Assessing electronic / paper records aiming to identify Data Integrity gaps with Risk-Based Approach to suggest the most appropriate mitigation / remediation actions.
- Ensuring that all project-related issues and deviations are recorded, approved and dispensed accordingly.
- Preparation of project and life cycle reports and review / approve all other documents to ensure compliance with SOP.
- Ensuring that all project and lifecycle documents achieve the goal of traceability, and are all retained in the document repository (Document Navigator) and approved following the prescribed SOP.
Requirements :
