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Validation Analyst

APOTEX INC.

North York, ON, CANADA | GTA, ON, CANADA
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About Apotex:

 

Apotex is the largest Canadian owned pharmaceutical company, and the largest producer of generic medicines in the country. We have an incredible team of bright, passionate, and committed individuals who are proudly dedicated to our mission of bringing a growing array of high quality, affordable medicines to the healthcare systems in 115 countries around the globe. We are looking for the cream of the crop to join our team!


We offer competitive pay, exceptional career development, state-of-the-art facilities, and the opportunity to work with leaders in the field. But we also offer something more… the satisfaction that comes from knowing that the “product” we produce will improve the quality of human lives, and in some cases, save them. Our products, most importantly, are also accessible by people from all economic backgrounds.

 
We’d love to hear how you could contribute to the team!

 

Job Summary:

 

• Responsible for planning, executing, coordinating and maintaining qualification activities for Computer Systems in accordance with regulations and defined Apotex quality standards and policies.

 

Job Accountabilities:

• Author validation documents such as IQ, OQ and PQ protocols and reports as per defined validation approach.
• Coordinate and manage test case authoring, execution, review and approval process.
• Execution of protocols/test procedures and verify results as necessary.
• Develop and maintain procedures for ensuring that the systems are qualified before release to the business.
• Develop and maintain procedures to regulate change implementation (Change Control Procedures) to ensure system compliance through its life cycle.
• Perform periodic reviews of systems.
• 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.
• Support audit defense during internal or external audits.
• Coach and mentor Business users and project team.
• Coordinate with the GIS-Project Manager and other team members to ensure timely completion of related tasks.
• Work with GIS or other support groups to outline the impact of changes based on which validation testing is performed.
• Effectively communicate the validation activities and deliverables to the project team.
• Provide support to implement and maintain the Computer System Registry.
• Demonstrate personal leadership attributes incorporating a commitment to ongoing professional development and continuous learning.
• Participate actively in department meetings and perform other duties as assigned.
• Follow quality values while conducting business on behalf of Apotex.
• Serve in a technical role providing guidance to other team members and other employees within information services.

• Resolve directly issues with internal customers, contractors and other internal stakeholders.

• Make complex interpretation and application decisions in their area of expertise.

• Develop and manage working relationships with their internal customers to acquire a sense of their information technology needs and develop a more in-depth knowledge of their business, market and deliverables.

• Understand and communicate department objectives, translating them into project team and individual performance goals.
• Develop an in-depth understanding of all Apotex policies, procedures and standards and operating processes associated with their information technology area.

 

Job Requirements:

 

• Minimum 2 years computer validation experience in health science industry.
• College Diploma / Bachelor degree in a related discipline.
• Good understanding of GMP’s and GAMP standards including validation process.
• Knowledge of FDA 21CFR Part 11 and other ER/ES regulations.
• Experience at writing/executing validation plans, IQ, OQ and PQ qualification protocols and reports for computerized systems.
• Relevant experience on Client/Server applications; RDMS Database (Oracle SQL Server) applications; SAP system, LIMS, Empower, Equipment Control validation (PLC/SCADA), Network and Enterprise Content Management Systems.
• Knowledge of Software Testing Tools is preferred.
• Excellent communication/interpersonal skills.

 

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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