Katalyst Healthcares and Life Sciences
Computer Systems Quality Assurance
Katalyst Healthcares and Life Sciences, Jersey City, New Jersey, United States, 07390
Job Description:
We are seeking an experienced Computer Systems Quality Assurance (CSQA) Specialist to support the expansion of our clients ERP systems and associated applications across new and existing manufacturing sites. The CSQA will provide quality oversight to ensure all systems are developed, validated, and maintained in compliance with corporate Computer System Validation (CSV) standards and regulatory guidelines.
Responsibilities:
Provide quality oversight 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 proper validation and documentation. Support audits and inspections by providing required documentation and responses. Utilize tools such as Veeva Quality Docs, ServiceNow, JIRA, and Client ALM to manage validation and compliance activities. Contribute to continuous improvement of IT Quality and CSV processes. Requirements:
7-12 years of relevant experience in IT Quality Assurance and Computer System Validation (CSV). Strong expertise in IT CSV validation of IT systems. Hands-on experience with Veeva Quality Docs, ServiceNow, JIRA, and Client 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.
Provide quality oversight 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 proper validation and documentation. Support audits and inspections by providing required documentation and responses. Utilize tools such as Veeva Quality Docs, ServiceNow, JIRA, and Client ALM to manage validation and compliance activities. Contribute to continuous improvement of IT Quality and CSV processes. Requirements:
7-12 years of relevant experience in IT Quality Assurance and Computer System Validation (CSV). Strong expertise in IT CSV validation of IT systems. Hands-on experience with Veeva Quality Docs, ServiceNow, JIRA, and Client 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.