What are the responsibilities and job description for the Computer System Validation Associate position at Onsite Personnel LLC?
Job Description
Job Description
Overview : Computer Systems Validation Associate :
Work as help desk staff for other cross functional teams as appropriate to determine and resolve problems. The CSV Associate will respond to queries, isolated problems and determine and implement solutions. Perform daily system monitoring to ensure that all computer-based system will produce information or data that meet predefined requirements. This position requires the ability to resolve end user problems quickly. You must have excellent communication skills (both verbal and written), must manage time effectively and have strong organizational skills. You must also possess the ability and judgment to escalate support requests if necessary.
Key Duties & Responsibilities : Computer Systems Validation Associate :
- Collaborate with system owner to develop URS, Design Qualifications, Functional Requirements, Unit test scripts, UAT scripts, Validation Plans and Protocols, Validation summary report and Traceability matrix
- Develop procedures specific to GxP Application SOP’s and provide SOP review for new systems.
- Perform Part 11 Assessments for new and existing computer systems
- Perform periodic reviews of validated GxP Systems
- Maintain GxP System log and update as necessary
- Participate in cross-functional project team meetings
- Execute the validation protocols, test scripts per Regulatory and GAMP guidance
- Perform Risk assessments for GxP systems
- Identify and implement opportunities for continuous improvement related to validation or other compliance practices / issues based on internal compliance issues, industry best practices as well as latest regulatory guidance’s and regulatory updates
- Identify, communicate and escalate project and compliance related issues associated with their projects to project Manager / Management
- Conduct training to individuals performing various roles within validation projects
- Review and assess the impact of new Patches to validated GxP systems and validation of new patches
- Initiate and resolving any non-conformance observes during periodic reviews through change and incident management
- Participate and coordinate with CFT for new projects
- Other duties as assigned
Education & Experience : Computer Systems Validation Associate :
Technical competencies / Certifications / Licenses : Computer Systems Validation Associate :
Benefits Include : Computer Systems Validation Associate :
Onsite Personnel is an equal opportunity employer committed to hiring a diverse workforce in an inclusive culture environment. Onsite Personnel does not discriminate based on disability, veteran status or any other basis protected under federal, state, or local laws.
