Description
Lead and implement validation strategy for Electronic Batch record implementation in MES environment. 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.SKILLS:
Minimum Bachelor's degree and background in software engineering, software quality assurance, software life cycle activities, or software validation.
- Hands-on professional with experience in the software life cycle (SLC) and is 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.
- Familiar with IEEE, SEI, ISO and have experience in a regulated environment.
- Analytical skills are important.
- Must be able to manage multiple tasks and resources.
- Good with verbal and written communication skills.