- 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
- 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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