Quality Assurance Sr. Associate

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.

What you will do:

• 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.

Who you are:

• Minimum of 3 years experience in the pharmaceutical or life science industry (e.g. veterinary, natural health products).
• College Diploma or University Degree in chemistry, biology or a related science.
• Experience working in a pharmaceutical manufacturing environment is an asset
• Customer focused
• Results driven and self driven
• Manages complexity and multiple tasks
• Prioritize, plans and aligns
• Detail oriented with attention to accuracy
• Works with minimum supervision. Works well independently or in a team oriented environment
• Effective communicator, both written and verbal skills.
• Sound understanding of documentation control principles, good manufacturing practices and quality system requirements.

What we offer:

• Competitive compensation and rewards package
• Collaborative, diverse and inclusive culture
• Career development and global opportunities
• Work-life flexibility programs such as flex hours, employee discounts, volunteer days, wellness, and other employee offerings

Bayer is committed to fostering, cultivating and preserving a culture of Inclusion and Diversity. We embrace and encourage our employees' differences and believe that our people are our most valuable asset. The collective sum of individual life experiences, knowledge, innovation, self-expression, unique capabilities that our employees invest in their work represents our culture, reputation, and Bayer's values and purpose.

Bayer welcomes and encourages applications from people with disabilities. Candidates participating in our selection process requiring accommodation due to a disability or medical need are encouraged to notify the Bayer representative that they will be meeting with to ensure appropriate arrangements can be made.

Location:

Canada : Ontario : Mississauga

Division:

Pharmaceuticals

Reference Code:

838228