CSV Validation Engineer

Company Description

PrimeForce Solutions is a global R&D solutions provider specializing in the life sciences industry. Our team's expertise in life sciences processes and technical knowledge allows us to deliver high-quality services to our clients. We focused on providing top-notch service to our customers.

Requirements :

Primeforce Solutions is looking for a Business Systems Analyst / Validation Engineer for a full-time role. Prior experience in validation of Clinical / Document Management / Regulatory systems is a big plus. Demonstrated working knowledge of GAMP 5, 'A Risk-Based Approach to Compliant GxP Computerized Systems' is a must.

Essential Job Function :

• Validation activities for GxP systems. Proven experience developing full validation documentation and testing protocols (URS, IQ / OQ / PQ / UAT, Change Controls, Deviation, CAPA) within the various SDLC phases.
• The Business Analyst will also be involved in performing periodic review and data integrity assessment of enterprise systems.
• Management of application access and permissions.
• Perform change management activities.
• Resolution of technical Issues.
• Creation of reports as needed.
• Support user training.
• Maintenance of system documentation. Author and develop standard operating procedure and work instructions required for application support and maintenance.
• Prior experience working in validated systems within a GMP / GxP environment is mandatory.
• Experience of working both independently and in a team-oriented, collaborative environment is essential.
• Flexible during times of change.
• Can conform and swiftly adjust to shifting priorities, demands, and timelines through analytical and problem-solving capabilities.
• Manages complex issues and risks and troubleshoots them as they arise.
• This role will regularly interface with all levels of the organization and with external vendors.

Core Competencies, Knowledge, and requirements :

Education

Other Qualifications :

Skills Required

Java, OQ, Uat, IQ, Sql, Capa, URS, RIMS, Computer Networking, Python, Deviation