Job Description
Roles and Responsibilities:
- 5+ years of hands-on CSV in GxP environments.
- Experience with risk assessments, URS, IQ/OQ/PQ, deviations, reports.
- Knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, ICH Q9, ALCOA+.
- Experience with lab instrument software.
- Preferred Qualifications
- Experience with CDS, LIMS and major vendor systems.
- Experience with Computer Software Assurance (CSA) principles.
- Experience with electronic testing tools (e.g. HPQC/ALM).
- GAMP or ASQ certifications.
- Degree in science or engineering.