As part of an overall cross functional Software Development Lifecycle (SDLC) approach to computer systems compliance and validation, the Computer Systems Validation (CSV) Specialist will be involved in all aspects of computer systems validation and qualification within a GxP regulated environment.
Under the general guidance of the CSV Lead and the direction of Sr. CSV Specialists, the CSV Specialist will be involved in the overall development and maintenance of GxP system lifecycle documentation.
Describe the essential daily job functions and include % of time spent on each.
- Validation Plans
- User Requirements Specifications
- Configuration, Functional, and Design Specifications
- Testing Protocols (IQ/OQ/PQ/UAT)
- Detailed risk assessment reports
- Requirements traceability matrices
- Validation Summary Reports
- Change Control Documentation
% of Time
Job Function and Description
- Participate/support the planning, development, and implementation of computer systems validation documentation.
- Review/approve 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
- Provide input into the support and maintenance of CSV and IT related SOPs, work instructions, and forms.
- May represent CSV on specific projects, conduct briefings and technical meetings for internal and external representatives, as needed
- BS degree in computer-science, Information Systems, Computer Engineering or related field is preferred.
- A minimum of 5 years of relevant work experience with 2 years of computer systems validation within a GMP/GxP regulated environment (FDA, EU, MHRA)
- 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.
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
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