Description
4 - 6 YEARS OF EXPERIENCE IN THE FOLLOWING:
RESPONSIBILITIES:
The candidate is responsible for all software quality assurance activities such as evaluation of software life cycle (SLC) deliverables for compliance with Operating Procedures, FDA requirements and the CFR including 21 CFR Part 11. Lead or participate in various reviews, risk analyses and other software quality assurance activities. Have a background in software engineering, software life cycle activities, or software validation and be familiar with the work products that result from SLC key activities. Knowledge or experience in requirements gathering, analysis techniques, software verification/validation techniques, configuration management techniques or documentation standards. The candidate should be familiar with IEEE, SEI, ISO and have experience in a regulated environment. Analytical skills are important, as is the ability to manage tasks. Must be able to manage multiple tasks and resources. Good with verbal and written communication skills.
REQUIRED:
Minimum Bachelor's degree, background in software engineering or software quality assurance. Hands-on professional with experience in the software life cycle (SLC).
Comments:
Candidate will be auditing IT System validation/verification packet System Life Cycle Documentation, for compliance to policies and Government regulations. Knowledge and experience in System Life Cycle (SLC)/Software Development Life Cycle (SDLC) and Good Manufacturing/Laboratory Practices (GXP).
Change Control documentation that will be audited for IT system Validation/Verification packets will include:
Synectics is an Equal Opportunity Employer.