QA Specialist Projects (Mississauga, Ontario, CA) na Bayer Global - Home | Bayer Global

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QA Specialist Projects 

QA Specialist – Projects, as part of the Product Community provide independent QA and GMP support for Consumer Health and Pharma projects such as new product launches, manufacturing and packaging site transfers, reformulations, line extensions, divestiture. This opportunity manages QA approval of artwork, new material setups, local packaging process approval and batch system release.

Bayer is committed to a flexible hybrid working environment. This is a permanent position based out of Mississauga, Ontario.

What you will do:

• Manage projects impacting their assigned portfolio of products independently by assuring that the resulting change or new product meet Health Canada's GMP requirements and the local quality systems are prepared for launch.
• Manage project timelines to meet business and supply center needs
• Provide advice upon request to Global Quality Managers on Health Canada GMP requirements
• Assess and approve project related Global Changes Controls.
• Initiate project related local change controls assuring all requirements of local quality systems are met and provide final approval.
• Review and approve Canadian third-party packaging procedures for prepacks secondary packaging and primary packaging as well as approval of the executed batch record.
• Assess and approve protocols and summary reports for local packaging qualification
• Manage method transfers.
• Review and approve product printed artwork.
• Ensure the timely review and implementation of assigned global procedures and Health Canada regulations within your community.
• Provide support to other team members or Community as needed, offering expertise and/or assistance to ensure cross-functional collaboration and the successful completion of shared objectives and outcomes.
• Collect and analyze data for KPIs of the systems under your responsibility to evaluate the system performance, providing insights to drive improvements and efficiencies. Apply an entrepreneurial mindset to identify and implement improvements. Communicate roadblocks, results and retrospectives to the Community Senior Specialist/ Lead.
• Develop, implement, and maintain Canadian procedures for which you are the owner/author. Ensure these procedures align with corporate and regulatory standards, continuously improving processes to enhance efficiency and compliance.
• Prepare thoroughly for audits and inspections of the systems under your responsibility. Define and oversee the implementation of appropriate corrective and preventive actions (CAPAs) based on audit observations and findings, ensuring timely resolution.
• Participate in a manner that fosters a culture of inclusion, continuous improvement, and accountability.

Who you are:

• University Degree or college Diploma in science (e.g. Chemistry, Biochemistry, Microbiology
• Minimum of 5-7years of experience in Quality Assurance or Quality Control within the pharmaceutical or biotechnology industry
• Good understanding of Health Canada regulatory requirements and Good Manufacturing Practices (GMP).
• Advanced knowledge of data integrity principles, good manufacturing practices and risk management.
• Strong influencing skills and conflict resolution expertise
• Strong project management, leadership, interpersonal skills and technical writing skills.
• High level of accountability, collaborative with an enabling and entrepreneurial mindset
• Fast learning, action-oriented and agile.
• Committed to professional development and embraces new learning opportunities including technology.
• Experience working in a pharmaceutical manufacturing environment is an asset.

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.

All referral candidates must first be submitted via our internal referral system by a current Bayer employee in order to participate in the referral program. Once a Bayer employee has successfully referred you in our system, you will receive an automated email with instructions on how to complete your application.

This posting will be available for application until October 30, 2025.

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:

855201