Canada-Quality Manager II
4 weeks ago
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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