Computer Systems Validation and Quality Assurance Associate
Location: New Brunswick
Posted on: May 16, 2022
The Computer Systems Validation (CSV) and Quality Assurance
Associate is responsible for providing validation support to
technical solutions and quality assurance support to technical
teams based on applicable regulations and company policies and
standard operating procedures.
- - Act as a CSV and/or computerized/automated systems compliance
lead on client project.
- Author the typical validation and testing documentation such as
Validation Plans/Summaries, Test Plans/Summaries, URS/FRS, Trace
Matrix, Qualification Protocols (IQ/OQ/PQ) and scripts, Testing
- Oversee and coordinate the systems testing efforts.
- Act in a leadership capacity: take ownership of related tasks,
work under minimal supervision, utilize the industry experience and
best judgment to make tactical decisions, etc.
- As may be requested, participate in Computerized System
Compliance activities other than CSV, such as procedures
development, infrastructure qualification, vendor assessments,
- - 3+ years of computerized systems compliance and CSV experience
- Understanding of GxP and Computer Systems role in support of GxP
compliance is required.
- Understanding of GAMP5 and risk-based approach to validation is
- Knowledge and understanding of relevant regulations, such as Part
11, Annex 11, Part 211, etc., is required.
- Ability to identify, define and propose the quality framework
improvements based on daily challenges is desired.
- Excellent communication and written skills required.
- Must be ambitious with strong work ethic.
- Ability in organizing and managing multiple projects, setting
priorities and working independently under aggressive timelines
- Be a fast learner with strong problem solving skills.
- Ability to work in highly demanding environment where teamwork is
- Demonstrated strength in verbal and written communication.
Job Type: Full-time
Apply Now: email@example.com
Keywords: SecureGen, New Brunswick , Computer Systems Validation and Quality Assurance Associate, IT / Software / Systems , New Brunswick, New Jersey
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