Quality Assurance Specialist - Compliance

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re 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 ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Quality Assurance Specialist - Compliance

The QA Specialist – Compliance – Manages the coordination, completion and maintenance of the Annual Product Review, Annual Stability 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, supports annual stability data/reports and processes product returns in accordance to Good Manufacturing Practices (GMPs), quality systems, regulatory and corporate regulations.

Bayer is committed to a flexible hybrid working environment. This is a 13-month contract position located in Mississauga, Ontario.

What you will do:

• Escalate any critical issues found during review to Manager QA Compliance relating to APR trends and/or site issues of Bayer’s products
• Management of the Annual Product Reviews requirements, obtaining, and reviewing all source site reports, collecting local systems data, and preparing Annual Product Review and Annual Stability summary reports for manager approval
• Act as an expert in APR, Stability, and Returns to provide support to other local quality systems
• Maintain KPIs for APR and product reviews
• 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
• Perform stability assessments for QA Project Management team for new launches, site changes, formulation changes, packaging changes, etc.
• Perform product impact assessment for transportation temperature excursions
• Negotiate updates or corrections to reports with Supply Centers
• Drive efficiencies and process improvements
• If required, Schedule Stability reviews for the year and monitor progress
• Detail oriented with attention to accuracy, ability to independently organize and prioritize tasks in a dynamic environment including the ability to manage multiple reports
• Support all method transfer projects and confirmatory testing programs
• 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
• Develop relationships with Supply Centers to help acquire documentation on time
• Support investigations team with root cause analysis for OOS in stability or other relevant deviations
• 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
• To ensure 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
• 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
• Responsible to develop and maintain all local procedures related to the Bayer APR, Stability (if required) and product returns assessment/dispositioning process while maintaining compliance with corporate and regulatory requirements

Who you are:

• Risk and conflict management skills
• Project management skills
• Ability to assess risk and use in decision making
• Sound technical writing capabilities in terms of Accuracy, Clarity, Conciseness, Readability, Correctness and an articulate communicator in both written and verbal form
• Sound technical writing capabilities in terms of Accuracy, Clarity, Conciseness, Readability, Correctness, and an articulate communicator in both written and verbal form
• Strong influencing and negotiating skills
• Pharmaceutical industry experience (minimum three years) performing APR, Stability reviews and product return assessments in accordance to Good Manufacturing Practices (GMPs)
• University Degree in Science (e.g. Analytical Chemistry, Biochemistry, Microbiology)
• At least 5 years’ experience in the pharmaceutical industry, in a QA or QC role
• Detail oriented with attention to accuracy, ability to independently organize and prioritize tasks in a dynamic environment including the ability to manage multiple priorities at once
• Knowledge of GMP, Project Management, Pharmaceutical Industry, Quality Assurance

This position requires full vaccination against COVID-19.

What we offer:

• Competitive compensation and rewards package
• Career development and global opportunities
• Collaborative, diverse and inclusive culture
• 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.

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: July 7, 2023

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:

795392