Overview

Responsibilities:

  • Be responsible for activities and quality systems
  • Ensure that activities, operations and products fully comply with company standards
  • Ensure Company’s activities comply to the applicable current regulations
  • Performs risk assessments as needed, and assists in determining preventive actions to prevent issues from occurring, for continual improvement initiatives, etc.
  • Reviews and approves change requests related to quality, production, facility and utility systems
  • Performs internal and external audits, as scheduled and assigned
  • Conducts investigations, as required, ensures the event is well-described, identifies the potential quality impact
  • Determines the root cause and corrective actions to minimize future events
  • Reviews and/or approves working Instructions and forms
  • Tracks and trends key quality performance indicators and conducts appropriate follow-ups as required
  • Provides cross departmental support to quality control, production, validation, engineering, etc.
  • Ensures the integrity and traceability of all data generated and reported
  • Performs other duties as assigned by Quality Lead

Required:

  • University Degree in Biology, Biochemistry, Chemistry, Microbiology or related discipline
  • 7+ years of experience in QA within pharmaceutical manufacturing industries, preferably having experience in biologics manufacturing
  • Excellent communication skills (verbal, written and presentation skills).
  • Able to problem-solve, be proactive and multi-task under strict deadlines
  • Able to rigorously apply, follow and maintain rules, regulatory requirements, procedures and processes
  • Must be an able to work independently and as part of a team
  • Strong knowledge of and ability to interpret and apply the applicable regulations of Canada and US
  • Highly organized, problem solving, analytical and focused;
  • Detail-oriented, thorough and methodical with strong interpersonal, organizational and communication skills

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