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Quality systems specialist

Green Cross Biotherapeutics Inc.

This is a Full-time position in Montreal, QC posted November 1, 2019.

Position Summary The Quality Systems Specialist is responsible for the activities and quality systems necessary to ensure that all GMP documents, systems and activities/operations are in full compliance with regulatory standards and Green Cross Biotherapeutics (GCBT) requirements.

Key Duties and Responsibilities Perform the following day-to-day functions, but not limited to: o Review/Approval of Deviations, Investigations, CAPA, Change Requests related GMP activities to comply to current GMP regulations o Review/Approval of Quality and Operations Activities and Documents (logbooks, room / equipment status, training records, investigations, etc.) in relation to Deviations, Investigations, CAPA, Change Requests Initiate Deviations, Investigations, CAPA, Change Requests related to GMP documents / processes, as required Ensure the integrity and traceability of all data generated and reported Generate new procedures and revise existing procedures, as required Gather Deviations, Investigations, CAPA and Change Request data for Annual Product Reviews Provide cross departmental support to production, QC, validation and engineering Develop and Report Quality Metrics for Change Requests and other systems, as assigned Follow appropriate gowning requirements in GMP areas Perform additional duties as assigned Qualifications Education: At minimum, must have a B.

Science, (Preferred: Microbiology, Chemistry, Biology) At least 6 10 years’ experience in QA within the Biopharmaceutical or Pharmaceutical Industry Specialist level expertise with advanced knowledge of quality systems (change control, deviations, investigations, root cause analysis, CAPA and risk assessments).

Demonstrates judgment, technical competence and knowledge critical for role.

Good computer skills with MS Office and Adobe Acrobat Strong organizational skills, including attention to detail and ability to meet deadlines Able to rigorously apply, follow and maintain rules, regulatory requirements, procedures and processes Must be able to work independently and as part of a team Able to multi-task under strict deadlines Achieves and exceeds goals Improves organization’s practices, processes and quality Leads improvement areas, develops procedures and processes.

Leads elements of the program, and defines execution plan based on department goals Supports colleagues and actively engages with colleagues Facilitate cross-functional collaboration and manage assigned projects Good oral and written communication skills and good interpersonal skills Bilingual in both French and English