Must possess 3 years of experience with a Masters degree, or 5 years with a Bachelors degree, in the followingbr br Validation engineering in the life sciences industry;br Defining validation strategies and executing validation engineering activities in compliance with 21 CFR Part 11 and in accordance with cGMP and applicable regulations, including FDA and GDPR;br Development of Standard Operating Procedures SOP, Validation Plans VP, Validation Protocols Installation Qualification, Operational Qualification and Performance Qualification, Requirement Traceability Matrix RTM and Summary Reports Validation and Test Summary Reports, VSRTSR;br Developing and reviewing User Requirement Specifications URS, Functional Requirement Specifications FRS and Design Specifications DS;br Investigating and implementing effective solutions for Issue Reporting, Deviations, and CAPAs
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