Quality Assurance Specialist

3 weeks ago

Mississauga, Canada Bayer Full time

**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**:

- 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
- Develop relationships with Supply Centers to help acquire documentation on time
- Negotiate updates or corrections to reports with Supply Centers
- Schedule APQR reviews for the year and monitor progress
- Escalate any critical issues found during review to Manager QA Compliance relating to APR trends and/or site issues of Bayer’s products
- If required, Schedule Stability 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, Stability (if required) 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
- 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
- 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
- Drive efficiencies and process improvements
- Maintain KPIs for APR and 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
- Act as an expert in APR, Stability, and Returns to provide support to other local quality systems
- Support investigations team with root cause analysis for OOS in stability or other relevant deviations
- 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

**Who you are**:

- University Degree in Science (e.g. Analytical Chemistry, Biochemistry, Microbiology)
- Knowledge of GMP, Project Management, Pharmaceutical Industry, Quality Assurance
- At least 5 years’ 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
- 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
- Sound technical writing capabilities in terms of Accuracy, Clarity, Conciseness, Readability, Correctness, and an articulate communicator in both written and verbal fo

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