Quality Assurance & Compliance Specialist

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 doesnt just wait for change but actively creates itwhere your skills and values drive our collective progress and impact.

JOB DESCRIPTION

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 involve 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.
• Proceeds 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 complete the appropriate documentation
• Ensure on time closure on the completed complaints.

Documentation & Systems

• Coordinates creation/review and issuance of all Standards Operating Procedures (SOPs)
• Maintains files on all SOPs
• Provides supports 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 participate in the SWAT meeting.
• Reviews Investigation/planned deviations prior to final approval.
• Ensures regular follow up on the open investigations/planned deviations to ensure on time closure.

MANAGEMENT RESPONSIBILITIES

Not applicable

OTHER DUTIES

Not applicable

LEVEL OF AUTHORITY

• Responsible of the eQMS.

PHYSICAL DEMANDS/WORKING CONDITIONS

Normal physical activities.

EDUCATION/COMPETENCE REOUIREMENTS

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

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.