Supervise, write, plan and execute the various protocols to ensure the validation of all systems, equipment, infrastructure and processes according to current Standards.
Training and supporting for technicians on validation principles.
PRIMARY FUNCTIONS
Drafting, review and approval of validation protocols for equipment, systems, infrastructures and processes.
Ensure that validation protocols are in compliance with the reasoning, strategies, methodologies and acceptance criteria defined for the department.
Coordinate and plan the execution of protocols.
Analyze, compile the results and approve validation protocols and reports.
Plan the use of the internal resources and coordinate their activities in order to meet deadlines.
Propose methods to improve the department’s work process.
Drafting and reviewing SOPs associated with the department.
Provide technical support to other departments.
Keep your supervisor informed about the activities under your responsibilities.
Carry out any other related tasks deemed relevant to the position.
EXPERIENCE REQUIREMENT AND APTITUDES
Bachelor’s degree in engineering or science, or any Training deemed equivalent.
7-10 years of experience in the pharmaceutical industry or equivalent.
Autonomous, Organized, Analytical skills and leadership.
Good oral and written communication in French and English, bilingual.
Good knowledge of Canadian and other countries Good Manufacturing Practices (GMP).
Good knowledge of MS Office software (Word, Excel, Powerpoint).
Ability to work in a team.
Manual Dexterity.
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Validation Specialist • Toronto, Canada
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