They are interested in temperature mapping experience, specifically CTUs, stability chambers, or similar environments. Strong lab instrument experience.
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.
Requirements:
Experience with CDS, LIMS and major vendor systems.
Experience with Computer Software Assurance (CSA) principles.
Experience with electronic testing tools (e.g. HPQC/ALM).