Analyst, Computer Systems Validation

Date: Jul 11, 2019

Location: North York, ON, CA, M9L 1N7

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 Computerized Systems in accordance with regulations and defined Apotex quality standards, procedures and policies.

Job Responsibilities
  • 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.
  • Effectively communicate the validation activities and deliverables to the project team.
  • Resolve directly issues with internal customers, contractors and other internal stakeholders.
  • Support departmental initiatives around Computer Systems Validation and Testing.
  • Coach and mentor business users and the project team members on Computer Systems Validation and Testing.
  • Perform periodic review of GxP impacting Computerized Systems.
  • Maintain and update records in the Computer System Registry as needed.
  • Develop an in-depth understanding of all Apotex policies, processes, and standard operating procedures associated with their information technology area.
  • 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.
  • 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

  • Understanding of GMP’s and GAMP standards, including validation process.
  • Knowledge of FDA 21 CFR Part 11 and other Electronic Records and Electronic Signatures regulations.
  • Experience with writing/executing validatin protocols and reports for Computerized Systems.
  • Functinal business area experience in using systems such as SAP, LIMS, Empower, PLC systems, Clinical systems etc.
  • God communication and interpersonal skills.

Experience

  • 2+ years Cmputer Systems 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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