Computer Systems Validation and Quality Assurance Associate

Company: SecureGen
Location: New Brunswick
Posted on: May 16, 2022

Job Description:

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.

Responsibilities:
- - 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 Defects, etc.
- 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, etc.

Must Have:
- - 3+ years of computerized systems compliance and CSV experience is required.
- Understanding of GxP and Computer Systems role in support of GxP compliance is required.
- Understanding of GAMP5 and risk-based approach to validation is required.
- 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 a must
- Demonstrated strength in verbal and written communication.

Job Type: Full-time

Apply Now: jobs@securegen.com

Keywords: SecureGen, New Brunswick , Computer Systems Validation and Quality Assurance Associate, IT / Software / Systems , New Brunswick, New Jersey