Validation Specialist

February 27 2019
Industries Pharmaceutical, Biotechnology
Categories Pharma, Biotech, Sciences, R&D, Quality assurance and control - Validation
Montreal, QC

ROLE AND RESPONSIBILITIES

Reporting to the Manager–Validation and Business Process Compliance, you validate the equipment, systems and processes for all of the organization's activity sectors to ensure that they comply with the requirements, in accordance with good manufacturing practices.

Specifically, you:

  • Write validation protocols and reports in keeping with users' needs and for regulatory purposes, according to the validation schedule;
  • Suggest and coordinate deviation-related corrective actions and solutions generated during validations;
  • Perform or coordinate the tests associated with the approved validation protocols;
  • Keep in good condition the testing equipment needed for validation;
  • Ensure that the validated systems, processes and equipment are maintained in keeping with the rules set out in the validation master plan; 
  • Interpret analysis results;
  • Attend the various meetings pertaining to validation projects;
  • Conduct preliminary studies for defining the validation metrics, when required.

REQUIREMENTS 

  • A college diploma or university degree in engineering, science or any other relevant diploma/degree; 
  • A minimum of 5 years of equipment validation experience in a regulated environment;
  • Proficient with the Microsoft Office Suite of programs and able to use various computer tools;
  • Good knowledge of English and fluent in French, both oral and written.

REQUIRED SKILLS 

  • Be known for being logical, having excellent analytical skills and team spirit;
  • Be thorough, organized and curious; 
  • Have an excellent client-focused approach; 
  • Be flexible and able to travel, when required, to Héma-Québec's various institutions;
  • Be comfortable in a highly regulated workplace.

Additional information

In addition to the competitive working conditions offered by Héma-Québec, this position includes the following benefits:

• Daily work schedule 35 hours per week;
• Four weeks of vacation per year (anticipated);
• Flexible schedule;
• Group insurance after three months of continuous service;
• Defined benefit pension plan.

Apply now!

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