Position: Validation Specialist

Location: Remote with occasional visit to client site in NYC

Employment type: 6 months contract

Description

Computer Systems Validation (CSV) Specialist will be involved in all the aspects of computer systems validation and qualification within a GxP regulated environment.

CSV Specialist will be involved in the overall development and maintenance of GxP system lifecycle documentation with minimum or no general guidance.

This includes:

• Validation Plans
• User Requirements Specifications
• Functional Requirements Specifications
• Configuration, Functional, and Design Specifications
• Testing Protocols (IQ/OQ/PQ/UAT)
• Detailed risk assessment reports
• Requirements traceability matrices
• Validation Summary Reports
• SOPs
• Change Control Documentation
• Responsibilities

Actively involved in the planning, development, and implementation of computer systems validation documentation.

Review and execute computer systems validation documentation

Initiate and oversee system CSV associated change control requests and associated validation documentation.

Facilitate, prepare, and execute CSV documents for Technical Operations, QC, QA, R&D, and IT groups as necessary. Ensures schedules, and performance requirements are met

Requirements

• 5-7 years of CSV experience
• Experience working in a GMP/GxP environment is required
• Proven experience developing full validation documentation and testing protocols (IQ/OQ/PQ/UAT) within the various SDLC phases.
• Demonstrated working knowledge of GAMP 5, “A Risk-Based Approach to Compliant GxP Computerized Systems
• Strong working knowledge of GxP/GMP compliance and guidance provided by USP, ASTM, ICH, EU, and FDA.
• Able to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries.
• Excellent oral and written communication skills in English.
• Experience with electronic document management systems (e.g., documentum, Qumas, SharePoint etc.); application development and lifecycle management (e.g., HP ALM, JIRA, etc.); familiar with IT service management systems (e.g., ServiceNow, SAP Solution Manager, etc.).
• Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project.
• Collaborate and communicate with other team members and stakeholders effectively.
• Advanced knowledge of complete MS Office suite and Visio.

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ClinChoice Inc. is an Equal Opportunity Employer / Committed to Diversity