Job Description

OPENTEXT - THE INFORMATION COMPANY

As 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.
As software and hosted service provider to the Life Sciences industry, you would be supporting our customers by having clear, documented processes, procedures, and controls in place to assure that our software products and hosted services are well tested, secure from vulnerabilities and meet functional requirements. Responsible for ensuring sufficient controls and processes for complying with quality regulations and associated audits from customers in the Life Sciences industry.
As a Sr Corporate Quality Analyst, you would be responsible to maintain policies and procedures to ensure the QMS remains effective. Manage key QMS processes including, but not limited to, Document Controls, Training, Audits, and Non-Conformance. Provide quality oversight by review and approve of SDLC and Validation deliverables. Assist in customer and compliance audits and remediation and collaborate with cross-functional teams for process improvement.
What You Will Do:

• 
  Manage Quality Management System (QMS)
• Maintain policies and procedures to ensure the QMS remains adequate and effective as regulations (where applicable), standards, and business needs change over time – per scheduled periodic review
• Manage key QMS processes including, but not limited to, Document Controls, Training, Audits, Non-Conforming Events, and CAPA
• Collaborate with stakeholders to ensure training compliance
• Maintain Engineering CAPA system
• Assist in customer and compliance audits and remediations
• Review and approval of Software Development Lifecycle (SDLC) deliverables and address issues
• Review of Computer System Validation (CSV) deliverables (Qualification Results/Validation Plan/Report)
• Manage process improvement activities

Qualification and Skills Required

• 
  Bachelor’s degree in Computer Sciences or related technical field
• Experience and working knowledge in FDA-regulated categories such as pharmaceutical, 21 CFR Part 11, and computer system validation would be valuable
• Working knowledge of QMS (ISO 9001, 21 CFR Part 820) would be valuable
• Experience and working knowledge with software development lifecycle and understanding deliverables such as project charter, test plan, test summary, and release report
• Excellent communication skills, both written and verbal
• Experience and familiarity using Tools like JIRA, Confluence, and MS Office
• Working knowledge in process improvement

OpenText's efforts to build an inclusive work environment go beyond simply complying with applicable laws. Our Employment Equity and Diversity Policy provides direction on maintaining a working environment that is inclusive of everyone, regardless of culture, national origin, race, color, gender, gender identification, sexual orientation, family status, age, veteran status, disability, religion, or other basis protected by applicable laws. Should you require accommodations during the selection process, please contact accommodationrequests@opentext.com.
Subject to applicable laws and regulations, OpenText’s global vaccination policy requires all employees to be fully vaccinated against COVID-19 to enter an OpenText office. Accommodations may be available for specific roles.