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Senior Quality Analyst
Aussicht: 133
Update Tag: 23-05-2024
Ort: Richmond Hill Ontario
Kategorie: Qualitätssicherung / Qualitätskontrolle
Industrie: IT Services IT Consulting Software Development
Position: Mid-Senior level
Jobtyp: Full-time
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Jobinhalt
Opentext - The Information CompanyAs the Information Company, our mission at OpenText is to create software solutions and deliver services that redefine the future of digital. Be part of a winning team that leads the way in Enterprise Information Management.
What You Will Do
- As member of team to manage activities to ensure compliance and effectiveness of the Life Sciences Governance program that supports OpenText products/services in the Life Sciences vertical:
- Review and approve of Software Development Lifecycle (SDLC) deliverables and address issues.
- Review and approval of Computer System Validation (CSV) deliverables (Validation Plan/ Qualification Results/ Validation Report and deviation management).
- Support and manage LS audits (gather evidence, present, and remediate issues). Answer / clarify related questions (in coordination with all other applicable company groups) regarding the development/release of on-prem/cloud products.
- Support audit questionnaires.
- Support Life Sciences RFIs/RFPs.
- Ensure compliance and effectivity of established cross-functional SOPs from development to deployment.
- Ensure cross-functional teams follow established processes.
- Manage process improvement activities.
- Support application change management in a regulated environment
- Ongoing expansion/development of Validation processes for Life Sciences vertical services
- Support OpenText mega-compliance audits (ISO/PCI/HIPAA/SOC/FedRamp, etc.).
- Assist in OpenText M&A activities regarding Engineering processes.
- Bachelor’s degree in Computer Science or related technical field.
- Experience and working knowledge in FDA-regulated categories such as pharmaceutical, 21 CFR Part 11, and computer system validation.
- Working knowledge of QMS (ISO 9001, 21 CFR Part 820).
- Experience and working knowledge with software development lifecycle and understanding deliverables such as project charter, test plan, test summary, and release report.
- Working high-level knowledge of cloud deployments.
- Excellent communication skills, both written and verbal
- Experience and familiarity using tools like JIRA, Confluence, MS Office.
- Working knowledge in process improvement.
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Frist: 07-07-2024
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