Quality Assurance and Control

At Pfizer, you will contribute to maintaining a strong and sustainable compliance culture across the site, ensuring alignment with Pfizer Quality Standards, Good Manufacturing Practices (GMP), applicable regulatory requirements, and site procedures.

You will support key compliance programs, including Training, Supplier Management and Qualification, External Supplier Audits, Data Integrity, Inspection Readiness, and Quality Systems.

Your responsibilities include:

• Coordinating the Site Training System, including training curricula, GMP training, learning assessments, training records, qualification requirements, and training compliance metrics.
• Partnering with departments to ensure appropriate training requirements are defined, maintained, and deployed in a timely manner.
• Supporting the Supplier Management System and Supplier Qualification Program, including supplier qualification, audit requests, Quality Agreements, and follow-up activities.
• Participating in External Supplier Audits, including the review of audit reports, CAPA action plans, and follow-up of audit commitments.
• Supporting the site's Inspection Readiness Program to maintain a continuous state of readiness for regulatory and internal inspections.
• Supporting Quality System activities, including monitoring compliance requirements and reviewing changes for alignment with the Pfizer Quality System.
• Participating in coordinating Data Integrity awareness and training activities and supporting the follow-up of identified gaps and corrective actions.
• Supporting the implementation and continuous improvement of the Site Data Integrity Program, including assessments, remediation activities, and adherence to ALCOA+ principles.
• Ensuring compliance with Pfizer Quality Standards, GMP requirements, and applicable regulatory requirements.
• Collaborating with cross-functional teams locally and globally, actively participating in cross-site forums and initiatives and contributing to continuous improvement across the Pfizer network.

Requirements:

• Master's or Bachelor's degree in Pharmacy, Biology, Chemistry, Engineering, or another relevant scientific discipline, with at least 2 years of relevant experience.
• Relevant experience in the pharmaceutical industry is required; experience in Compliance, Quality Assurance, or Quality Control would be an advantage.
• Good understanding of Good Manufacturing Practices (GMP) and pharmaceutical quality systems.
• Strong understanding of regulatory requirements and compliance standards.
• Knowledge or experience in Data Integrity and ALCOA principles.
• Knowledge of Quality Risk Management processes.
• Excellent attention to detail and organizational skills.
• Strong analytical and problem-solving skills with a continuous improvement mindset.
• Ability to manage multiple priorities and meet agreed timelines.
• Effective written and verbal communication skills in both English and French.
• Ability to collaborate effectively with cross-functional teams.
• Proficiency in Microsoft Office applications, particularly Excel, PowerPoint and Word.