Quality Assurance Sr. Associate

at  Bayer

QA SR. ASSOCIATE

Review and disposition bulk and finished products (including drug products, natural health products and medical devices), for Canadian manufactured/packaged/tested or imported products, as assurance that all activities have been performed in accordance with local, corporate and regulatory requirements. Support the coordination and maintenance of Quality Systems.

• Review and disposition (approve/reject) bulk and finished products for market availability.
• Liaise with supply centers to drive timely resolution of batch related issues.
• Initiate or approve internal minor deviations.
• Approve deviations received from supply centers.
• Actively collaborate with internal/external stakeholders to understand the needs of the business. Plan, prioritize, communicate and distribute team workload to drive business needs.
• Communicate compliance expectations and provide compliance support to CMOs and third party contractors (fabricators, laboratories and warehouses) for product release requirements.
• Initiate or approve change controls as well as ensure the timely completion of change control action plans associated with product launches, test methods and release related process changes.
• Prepare or approve finished product release specifications.
• Routinely monitor and review SOPs, data retention systems, GDPs, products and employee output for compliance and consistency.
• Maintain and retain all QA documentation in accordance to quality system requirements.
• Maintain and evaluate departmental KPIs to identify and action trends noted.
• Support, participate and/or drive continuous process (efficiency and compliance) improvement or business/departmental initiatives
• Invoice approvals
• Deliver qualification training for new hires. Coach junior staff.