| Laboratory Validation Specialist at Indianapolis, Indiana, USA |
| Email: [email protected] |
| From: shrasti singh, vyzeinc [email protected] Reply to: [email protected] Job Description - Title: Laboratory Validation Specialist Computerized System Assurance (CSA) 3 months to start Location: Indianapolis, IN | Onsite Visa: All Need LinkedIn 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 Keywords: information technology green card Laboratory Validation Specialist [email protected] |
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| Thu Dec 12 03:29:00 UTC 2024 |