Validation Lead
Yochana
Job Title
Senior Consultant with expertise in Computer System Validation ERP/WMS, R&D systems
• 7-10 years’ experience in Computer System Validation ERP/WMS, R&D systems
• A senior consultant with expert knowledge of GxP and Computer System Validation. Expertise in authoring and reviewing all CSV validation deliverables.
• Proficient in Compliance Plan, User Stories, Testing, Traceability Matrix and SDLC lifecycle activities.
• Knowledge in utilizing SDLC tools such as JIRA, AM, qTest, X-ray etc. Knowledge of Cloud Based qualification and validation, CI/CD methodology, Jenkins and Bitbucket usage preferred.
• Experience with Backup & Restore GxP activities preferred.
• Proficient knowledge on CFR Part 11 regulations and Quality Management Regulations.
• Expertise in SOP and WI authoring and reviews.
• Proficient with change control management and utilization.
• Prefer an individual with great communication skills, ability to work proactively and independently.
• Ability to interact and lead conversations and meeting with Business Partners independently to lead and guide GxP policies and regulations.
• Interact with technology partners to ensure compliant working and operation of supported GxP systems
Application of FDA guidance’s and industry standards (i.e., GAMP).
Vacancy posted 5 days ago
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