Quality Assurance & Compliance Specialist

Quality Assurance & Compliance Specialist

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Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it, where your skills and values drive our collective progress and impact.

Job Description Position Title

Quality Systems Specialist

Reports to

Quality Systems Manager

Date

November 13, 2025

Location Code (Corporate)

Laval

Position Summary

The Quality Systems Specialist ensures that Quality Systems operations comply with Bausch Health Inc. standards and external regulatory requirements. This role is responsible for Quality Systems oversight, document review and action follow‑up. The candidate may be called upon to be involved in one or more of the Quality Systems. The position supports continuous improvement initiatives, risk mitigation, and regulatory inspection readiness.

Major

Areas of Responsibility Annual Product Review (APR)

• Compile the data necessary to generate the APR.
• Verify that the completeness of the data gathered.
• Proceed to document circulation for approval.

Change Controls (CR)

• Coordinates the CR process with the users.
• Actively participate/chair in the CR meeting.
• Reviews CRs prior to complete approval.
• Ensures regular follow‑up on the open CRs to ensure on‑time closure.

Corrective Action Preventive Actions (CAPA)

• Coordinates the CAPA process with the users.
• Actively participate in the CAPA meeting.
• Reviews CAPA prior to complete approval.
• Ensures regular follow‑up on the open CAPA to ensure on‑time closure.
• Follows the Effectiveness Check (ECR) process post CAPA implementation.

Customer Complaints

• Assigns each incoming complaint a case number.
• Investigates each complaint and completes the appropriate documentation.
• Ensures on‑time closure of the completed complaints.

Documentation & Systems

• Coordinates creation, review and issuance of all Standards Operating Procedures (SOPs).
• Maintains files on all SOPs.
• Provides support to the departmental Documentation Coordinators.
• Manages the retain samples.
• Ensures regular follow‑up on pending SOP trainings.

Investigations/Planned Deviations

• Coordinates the investigation/planned deviation process with the departments.
• Actively participates in the SWAT meeting.
• Reviews investigations/planned deviations prior to final approval.
• Ensures regular follow‑up on the open investigations/planned deviations to ensure on‑time closure.

Other Duties

Not applicable

Level of Authority

• Responsible for the eQMS.

Physical Demands / Working Conditions

Normal physical activities.

Education / Competence Requirements Qualifications

• Bachelors degree in Life Sciences, Pharmacy, Chemistry, or related field.
• 3+ years of experience in pharmaceutical compliance, quality assurance, or auditing.
• Strong knowledge of GMP, GDP, ICH guidelines, Health Canada and FDA, and regulatory requirements.
• Experience with quality systems in a life science environment.
• Familiarity with a manufacturing environment.
• Excellent communication, organizational, and problem‑solving skills.
• Ability to work independently and collaboratively in a fast‑paced environment.

Administrative/Managerial

Competencies:

Results oriented; teamwork oriented.

Interpersonal Skills/

Competencies:

Meticulous, efficient, consistent, reliable, and persuasive.

Other:
Excellent oral and written communication skills in French and English, Outlook, Word, Excel and PowerPoint.

DISCLAIMER STATEMENT

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, skills, and competencies required of personnel so classified.

Direct report: N/A

We are an Equal Opportunity Employer. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.

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