Executive, GIS
2 weeks ago
Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.
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Job Summary
Responsible for planning, executing, coordinating and maintaining qualification activities for Computerized Systems in accordance with regulations and defined Apotex quality standards, procedures and policies.
Perform system risk and GxP impacting assessment.
Author validation documents such as validation protocols and reports, as per the defined validation approach.
Coordinate and manage test procedure authoring, execution, review and approval process. Coordinate execution of protocols and verify results.
Develop and execute remediation plans for existing systems to ensure compliance with applicable regulations.
Implement validation programs as per corporate Validation Master Plan/GIS Testing Methodology.
Develop testing approach for system implementations.
Develop and maintain procedures for ensuring that the systems are qualified before release to the business.
Develop an in-depth understanding of all Apotex policies, processes, and standard operating procedures associated with their information technology area.
Lead project tasks related to Computer Systems Validation in laboratory, manufacturing, facilities, clinical and other functional areas.
Effectively communicate the validation activities and deliverables to the project team.
Resolve directly issues with internal customers, contractors and other internal stakeholders.
Coach and mentor business users and the project team members on Computer Systems Validation and Testing.
Perform periodic review of GxP impacting Computerized Systems.
Perform SATR execution of GxP impacting Computerized SystemsPerforming QMS activities (Assessmements,Action item creations and verifications)Maintain and update records in the Computer System Registry as needed.
Work in a safe manner collaborating as a team member to achieve all outcomes.Demonstrate Behaviours that exhibit our organizational Values:
Collaboration, Courage, Perseverance, and Passion.
Demonstrate personal leadership attributes incorporating a commitment to ongoing professional development and continuous learning.
Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
All other relevant duties as assigned.Job Requirements
Education Bachelor degree in a related discipline.
Knowledge, Skills and Abilities Understanding of GMP's,GCP and GAMP standards, including validation process.
Good communication and interpersonal skills.21CFR Part 11 compliance regulatory requirements.
Knowledge on GAMP5Basic knowledge on MS office.
Experience Minimum 3 Years of Exeperience in in GMP regulated health science / Pharmaceautical Industry.
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.-
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