Associé senior, assurance qualité / Senior, Quality Assurance Associate

SERVIER MONDE•Laval, QC

1d•Hybrid

About The Position

Servier Canada is currently seeking a Senior, Quality Assurance Associate to ensure compliance with Health Canada requirements, Good Manufacturing Practices (GMP), and internal quality standards. This individual will be responsible for ensuring the quality, efficacy, and safety of Servier Canada’s medications. They will also be responsible for maintaining compliance with Servier Canada’s quality system, including, but not limited to, the management of deviations, nonconformities, quality complaints, change controls, CAPA (corrective and preventive actions), and quality activities related to subcontractors. The ideal candidate demonstrates a strong attention to detail and a commitment to the highest standards of quality, compliance, and operational excellence in a regulated pharmaceutical environment.

Requirements

Bachelor’s degree in Life Sciences or Health Sciences
10 years of experience in a similar role; hands-on experience in a pharmaceutical manufacturing facility or production environment is strongly preferred.
In-depth knowledge of the Canadian regulatory framework and expertise in matters related to the Food and Drug Regulations and Good Manufacturing Practices (GMP).
Ability to effectively manage tight deadlines and solve problems in a constantly changing environment.
Excellent proficiency in English and French (spoken and written)

Responsibilities

Ensure compliance with Health Canada laws, regulations, and guidance documents applicable to Good Manufacturing Practices (GMP), as well as with internal quality standards.
Maintain and support the continuous improvement of Servier Canada’s quality management system.
Manage quality risk, including impact assessment, prioritization of issues, and documentation of quality decisions.
Maintain quality performance indicators and contribute to the annual review of the quality system.
Review, prepare, and submit the annual renewal of the drug establishment license as well as any applicable amendments.
Review, prepare, and submit the renewal of the site license for natural health products and any applicable amendments.
Review, prepare, and submit natural health product licenses, as required.
Review batch records and determine product disposition in accordance with applicable requirements.
Manage deviations, nonconformities, and quality complaints, including evaluation, follow-up, and closure within the required timeframes.
Manage change controls, including assessment, follow-up, and closure within the required timeframes.
Manage CAPA actions, including assessment, follow-up, and closure within the required timeframes.
Manage product withdrawals and recalls in collaboration with internal and external stakeholders.
Manage annual product quality reviews and contribute to the identification of trends, risks, and opportunities for improvement.
Manage quality procedures, including their review, updating, and compliance with internal and regulatory requirements.
Ensure quality oversight of suppliers and subcontractors, including monitoring investigations, CAPA, performance indicators, and quality commitments.
Manage, review, and monitor quality agreements with applicable suppliers, subcontractors, and partners.
Coordinate and/or conduct internal, external, and corporate audits, as well as regulatory inspections, including those by Health Canada.
Serve as the quality contact during audits and inspections, and follow up on observations, commitments, and corrective actions.
Support inspection preparation activities and help maintain inspection-ready documentation.
Contribute to the teams’ ongoing training to strengthen compliance with quality standards and regulatory requirements.
Support and develop the team’s technical capabilities by serving as a quality assurance resource.
Perform any other related tasks in line with quality responsibilities and organizational priorities.

Benefits

A flexible hybrid work environment to support work-life balance (office located in Laval, QC)
Company-wide holidays between Christmas and New Year’s
An outstanding retirement plan
Employer-paid group insurance starting from day one
Competitive compensation, including a performance bonus
An annual flexible health spending account
A monthly internet allowance
An annual fitness allowance
An inclusive work environment
Access to a library of online conferences and training programs