| Urgent role: CSV Engineer Validation Engineer Computer Systems Validation Engineer at Remote, Remote, USA |
| Email: [email protected] |
| From: vishal, Tekinspirations [email protected] Reply to: [email protected] Hi, I Hope you are doing great. Please find below position if you have any matching candidate as per requirement. Please send me updated resume with candidate information. Job Titles- CSV Engineer, Validation Engineer, Computer Systems Validation Engineer Keys- CSV Engineer with Data Integrity and IT Infrastructure experience as well as Pharma/Biopharma industry experience. He is transitioning from a CSV group to one focused on IT Infrastructure, lower-level components, storage, data integrity, audits, and qualifications. Job Responsibilities include, but are not limited to, the following: Ensures GxP quality standards, applicable regulatory compliance, and company guidelines/policies are created and maintained through the development of the Data Governance Program Collaborate with other functional areas to collect information and provide guidance through all stages of the quality management system and improvement projects Assist in creating and managing Data Governance Program metrics, policies, and projects Ensures new systems/processes/procedures are compliant with SOPs, WIs and data and regulatory guidelines. Assist in resolution of inspection management concerns as it relates to process, procedures, and data integrity Reviews deviations, change controls, SOPs and corrective actions to assess for compliance with established regulatory requirements, GxP guidance and company policies and procedures. Investigates compliance problems and recommends solutions to improve compliance and prevent repeat occurrences of deviations. Experience: 7+ years of experience in IT, Computer Science, Engineering, or Chemistry in an FDA regulated manufacturing environment. Thorough understanding of IT CSV, IT QA, and Data Governance roles and responsibilities in support of GxP compliance is required Experience working in an FDA regulated environment with a strong emphasis on a risk-based approach to validation/qualification Strong knowledge of FDA CFRs, Eudralex, and other biotech/pharma industry regulations (pertaining to IT, laboratory systems, automation, and manufacturing) Strong knowledge of Data Integrity, System Development Life Cycle (SDLC) validation methodology and Software Quality requirements. Understanding of root cause analysis and risk management techniques Experience with quality management systems including change control, incident management, and deviation management. Vishal chaurasiya Technical Recruiter Desk : 469-498-0625 Email: [email protected] TEK Inspirations LLC : 13573 Tabasco Cat Trail, Frisco, TX 75035 Keywords: quality analyst information technology Texas |
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| Sat Aug 05 04:07:00 UTC 2023 |