Computer Systems Validation Analyst

Date: Jun 26, 2019

Location: Brantford, ON, CA, N3T 6B8

Company: Apotex

 

Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world. We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion. Our fully integrated operation is comprised of four lines of business: Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year. We produce 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.

 

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 Responsibilities
  • Author the full suite or computer system validation documents (e.g. VP, URS, DS/CS, IQ/OQ/PQ protocols and reports, VSR, etc.) 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.
  • Perform periodic reviews of systems.
  • Develop and execute remediation plans for existing systems to ensure compliance with applicable regulations.
  • Implement validation programs as per the Global Computer System Validation Master Plan/GIS Testing Methodology.
  • Support audit defense during internal or external audits.
  • Coordinate with the project leaders/managers 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 Inventory.
  • Resolve issues with internal customers, contractors and other internal stakeholders.
  • 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.
  • Works as a member of a team to achieve all outcomes.
  • Works 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.
  • 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
    • College Diploma / Bachelor degree in a related discipline.
  • Knowledge, Skills and Abilities
    • Familiarity with validation process including writing/executing CSV documentation (e.g. VP, URS, DS/CS, IQ/OQ/PQ protocols and reports, VSR, etc.) for computerized systems.
    • Functinal business area experience in using systems such as SAP, LIMS, Content Management Systems, Quality Management Systems, Empower, Manufacturing systems (PLC/DeltaV), etc.
  • Experience
    • Minimum of 0-2 years computer system validation experience in health science 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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