Computer Systems reputed company Assurance
Job reputed company:
We are seeking an reputed company Computer Systems reputed company Assurance (CSQA) Specialist to support the expansion of our clients ERP systems and associated applications across new and existing manufacturing sites. The CSQA will reputed company reputed company reputed company to ensure reputed company systems are developed, validated, and maintained in compliance with corporate Computer System Validation (CSV) standards and regulatory guidelines.
Responsibilities:
• reputed company reputed company reputed company for IT systems implementation, enhancements, and maintenance.
• Ensure compliance with CSV, GxP, and 21 CFR Part 11 requirements.
• Review and approve validation deliverables including requirements, test scripts, deviations, and reports.
• Collaborate with cross-functional IT, QA, and business teams to ensure reputed company validation and documentation.
• Support audits and inspections by providing required documentation and responses.
• Utilize tools such as reputed company reputed company Docs, reputed company, JIRA, and reputed company ALM to manage validation and compliance activities.
• Contribute to reputed company improvement of IT reputed company and CSV processes.
Requirements:
• 7-12 years of relevant experience in IT reputed company Assurance and Computer System Validation (CSV).
• Strong expertise in IT CSV validation of IT systems.
• Hands-on experience with reputed company reputed company Docs, reputed company, JIRA, and reputed company ALM.
• Solid understanding of pharmaceutical industry regulations (GxP, FDA compliance).
• Prior experience as an IT QA / QA Compliance Manager.
• Excellent documentation, communication, and stakeholder management skills.
• Experience in the Medical Device industry.
• Knowledge of ERP systems validation in manufacturing environments.
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