At Bayer we\xe2\x80\x99re visionaries, driven to solve the world\xe2\x80\x99s toughest challenges and striving for a world where ,Health for all, Hunger for none\xe2\x80\x99 is no longer a dream, but a real possibility. We\xe2\x80\x99re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining \xe2\x80\x98impossible\xe2\x80\x99. There are so many reasons to join us. If you\xe2\x80\x99re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there\xe2\x80\x99s only one choice.
Sr. Quality Assurance Associate
The QA Sr. Associate - Annual Product Reviews and Returns \xe2\x80\x93 Manages the coordination and maintenance of the Annual Product Review and Returns assessment/dispositioning systems in accordance with local, global and regulatory requirements. A member of the QA Compliance team at Bayer Inc. Obtains and performs quality reviews of supplier annual product reviews and processes product returns in accordance to Good Manufacturing Practices (GMPs), quality systems, regulatory and corporate regulations. Assists with annual stability reviews and reports and internal stability at 3rd party lab.
Bayer is committed to a flexible hybrid working environment. This is a 15-month maternity leave Short Term Assignment/Contract position.
What you will do:

• Responsible for liaising with source sites in terms of the Annual Product Reviews requirements, reviewing all source site reports, collecting local systems data, and preparing Annual Product Review summary reports.
• Schedule APQR reviews for the year and monitor progress
• Responsible to collect and assess product returns for suitability to return to stock. Work with 3rd party warehouse to ensure all required information is received for assessment. Ensure that 3rd party warehouse abides by and confirms returns disposition decision.
• Responsible to develop and maintain all local procedures related to the Bayer APR and product returns assessment/dispositioning process while maintaining compliance with corporate and regulatory requirements.
• Assist with liaising with source sites in terms of the Annual Stability Reviews requirements, reviewing all source site reports and preparing Annual Stability Review summary reports.
• Assist with liaising 3rd party contract lab for stability testing to ensure products are tested at appropriate time points, testing CoAs are received and reviewed, Annual Stability reports completed and samples for On Going Stability studies are sent to lab.
• Detail oriented with attention to accuracy, ability to independently organize and prioritize tasks in a dynamic environment including the ability to manage multiple reports
• Escalate any critical issues found during review to Manager QA Compliance relating to APR trends and/or site issues of Bayer\xe2\x80\x99s products.
• Support all method transfer projects and confirmatory testing programs
• Support the documentation system/training system
• Support Medical Information Inquiries
• Drive efficiencies and process improvements
• Maintain KPIs for product reviews
• Thoroughly prepare and actively support audits and inspections of the APR and product returns dispositioning. Assist in defining appropriate CAPAs based on the observations and findings and oversee implementation by the defined due date.
• Ensures that the Bayer Inc. Quality Assurance and Quality Control operations and team operate at the highest level of compliance and business efficiency, as well as provide the necessary support from a compliance perspective to the business groups.

Who you are:

• University Degree in Science (e.g. Analytical Chemistry, Biochemistry, Microbiology);
• Knowledge of GMP, Project Management, Pharmaceutical Industry, Quality Assurance.
• At least 3 - 5 years\xe2\x80\x99 experience in the pharmaceutical industry, in a QA or QC role;
• Sound technical writing capabilities in terms of Accuracy, Clarity, Conciseness, Readability, Correctness and an articulate communicator in both written and verbal form;
• Pharmaceutical industry experience (minimum three years) performing APR and Stability reviews in accordance to Good Manufacturing Practices (GMPs);
• Project management skills;
• Risk and conflict management skills

This position requires full vaccination against COVID-19.
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\xe2\x80\x99 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\xe2\x80\x99s values and purpose.
Learn more about our values and purpose at: https://www.bayer.com/en/ca/canada-our-purpose-values
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.
Application Deadline: April 10, 2023
#LI-CA 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: 789452