Canada-Quality Manager II

4 weeks ago


Toronto, Canada TalentBurst, Inc. Full time
Job Title:- Quality Manager II (Engineering)
Location:- Toronto, ON
Duration:- 06+ Months Contract

Job Description
  • Strong Quality Mindset
  • The ability to effectively communicate, both verbally and in written format, through multiple layers of the organization and the ability to think strategically are key to the individual's success.
  • Excellent interpersonal and influencing skills and must be able to work in a cross-functional team-based environment.
  • Strong technical background and knowledge in both FDA/EU quality compliance requirements and validation requirements.
  • Ability to work in a diverse environment and draw upon experience in determining the actions needed to achieve results and remediate issues.
  • Ability to work in a fast paced environment and make balanced quality decisions.
  • It would be preferred if the candidate has experience with Document Management Systems (such as QualiPSO etc.) applications and trained in Change Management, Nugenesis, Kneat Paperless Validation system etc.
  • Demonstrated ability to meet/exceed timelines/deliverables.
  • Experience with computerized systems validation, validation of Delta V, Data Historian OSI PI, and Manufacturing Execution System MES is an asset.
  • Education
  • Bachelor's Degree in the field of Science or Engineering, with 5+ years of experience in a GMP regulated environment.
  • Minimum 5 years' experience in review and auditing of GMP documentation.
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