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Senior Corporate Quality Assurance Specialist
1 month ago
Position Overview
The Senior Corporate Quality Auditor will be responsible for executing the national corporate audit strategy in collaboration with the Senior Manager, Corporate Quality and Compliance Excellence and internal stakeholders.
Key Responsibilities:
- Develop and execute the corporate periodic self-inspections plan.
- Assist the Senior Manager, Corporate Quality and Compliance Excellence in assessing the current state of the site quality system process documentation and partner with key business units to strive for continuous improvement/best practices.
- Prepare and execute the corporate vendor audit plan and conduct assigned vendors audits.
- Ensure compliance activities milestones are met.
- Audit the Quality systems and associated processes for integrity of GxP documents and determine discrepancies.
- Ensure that audit issues are well documented and root causes are identified and addressed.
- Collect information on remediation efforts, track progress and communicate milestones and deliverables to Senior Manager, Corporate Quality and Compliance Excellence and relevant stakeholders.
Requirements:
- Bachelor's degree in science or related field.
- Minimum of 7 years of experience in pharmaceutical industry including auditing role.
- Excellent knowledge of cGMP, Controlled Substances regulations, precursors regulations, and Medical Device regulations in pharmaceutical environment.
- Knowledge of Good Pharmacovigilance Practice and pharmacovigilance regulations considered an asset.
Additional Skills:
- Strong analytical and problem-solving skills.
- Ability to work independently and make decisions based on judgment and integrity.
- Good written and oral communication skills in both English and French.
- Ability to handle multiple assignments in a fast-paced environment.
- Facts and data driven with attention to details to ensure consistency.
- Strong interpersonal skills.
- Ability to collaborate with various levels of management and teams.
- Ability to lead continuous improvement activities through involvement and engagement of others.
