| Validation Lead || No H1B or CPT at Remote, Remote, USA |
| Email: [email protected] |
| From: Mani, Pinakastaffing LLC [email protected] Reply to: [email protected] Work schedule details: Onsite - Schaumburg, IL, 10% travel (4days onsite, 1 day remote) Work Authorization: all are accepted c2c TITLE: Validation Lead Terms: 6 month contract (chance of extension based on performance) The Quality Assurance (QA) Validation Lead is responsible for the Computer System Validation (CSV) and change control processes in a GxP-regulated environment. The QA Validation Lead provides compliance guidance to InClin business leadership and CSV System stakeholders. They will be leading a small team of 2. Top Skills: 10+ years with driving Computer System Validation principles and Quality Management Systems (21CFR Part 11, GAMP- 5, EU Annex 11 and other relevant regulations). 5+ years of related experience in a cGMP facility, including experience with FDA regulations, medical, drug and device products. Installation, Operational and Performance Qualification protocol generation and execution experience Knowledge of cGMP Process and Product Validation requirements and techniques. Nice to Have: High degree of proficiency in Microsoft Office Suite and Smartsheet Detail-oriented with a strong analytical mindset and problem-solving capabilities Excellent project management skills, with the ability to lead cross-functional teams and manage multiple projects simultaneously Keywords: quality analyst Illinois Validation Lead || No H1B or CPT [email protected] |
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| Fri Oct 04 23:15:00 UTC 2024 |