| CSA Validation Manager SaaS ALM GAMP 5 Raleigh, NC Hybrid at Raleigh, North Carolina, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2579491&uid=60cb542cad7c44f390c0d75c549773a5 From: Praveen Nagar, Vyze inc [email protected] Reply to: [email protected] Job Description - Note : Need local candidates with DL, VISA AND LINKEDIN. Job Title: CSA Validation Manager SaaS / ALM / GAMP 5 Location: Raleigh, NC (Hybrid 3 days onsite) Type: 5-Month Contract Start Date: ASAP Overview: Were hiring a CSA Validation Manager to lead the development and execution of a Computer Software Assurance (CSA) strategy for R&D IT systems at a leading pharmaceutical company. This includes overhauling validation processes, implementing an ALM system, and developing SOPs and templates. The ideal candidate has strong SaaS validation experience, technical writing skills, and a deep understanding of regulatory frameworks. Key Responsibilities: Design and implement CSA frameworks aligned with GAMP 5, 21 CFR Part 11, and EU Annex 11 Lead stakeholder sessions and business process reviews Create SOPs, work instructions, training content, and validation documentation Roll out and support a GxP-compliant SaaS-based ALM tool Manage validation of R&D IT systems, including AI and lab applications Ensure compliance with internal policies and global regulatory requirements Required Qualifications: Bachelors degree in Computer Science, Information Systems, or related field 57 years of validation experience in pharma or medical device industry Hands-on experience with SaaS validation and CSA principles Strong knowledge of GAMP 5, 21 CFR Part 11, and EU Annex 11 Proven ability to write SOPs, validation templates, and technical documentation Experience implementing and supporting ALM tools in regulated environments Preferred Qualifications: Direct experience implementing CSA frameworks Experience validating lab instruments, AI models, and IPCs Familiarity with SaaS-based ALM tools in GxP settings Keywords: artificial intelligence rlang information technology North Carolina CSA Validation Manager SaaS ALM GAMP 5 Raleigh, NC Hybrid [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2579491&uid=60cb542cad7c44f390c0d75c549773a5 |
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| 05:47 AM 10-Jul-25 |