Laboratory Validation Specialist Computerized System Assurance (CSA) - Katalyst Healthcares & Life Sciences
South Plainfield, NJ 07080
About the Job
| " Expert in CSA validation principles. " Automated testing experience a must " Develop a strategy to convert existing CSV approaches to lab validation into a CSA documented process. " Developing, reviewing, and executing testing documentation. " Direct experience and understanding of complex lab systems such as HPLC, GC, TOC, UV/Vis, Plate Readers and automated titrators " Hands on experience with lab techniques and general lab analytical operations. " Understanding of baselined lab standards and system suitability verification. " Basic experience with IT system formats, configurations, and workflows. " General understanding of the business processes supporting one or more domains, such as: Clinical, Quality System Management, Commercialization. " Create and revision of all IT CSV project and system deliverables including but not limited to: o Plans o Requirements o Specifications o Test Protocols, Scripts and associated execution deliverables (such as test incident reports, etc. o Summary Reports o Change Controls " Review system operational and administration procedures to ensure they are adequate " Document any findings of non-compliance " Assist with strategy regarding remediation activities " Assist with review of remediation activities " Must be willing to work onsite in Indianapolis, IN " Strong understanding of CSA principles and how to leverage them in a lab validation setting. " Experience in pharmaceutical cGxP setting with the ability to generate CSV deliverables with support of mentor. " Act as the Subject Matter Expert on various pieces of lab equipment " Demonstrated experience in leading lab CSV activities specific to Process Equipment |
Source : Katalyst Healthcares & Life Sciences