Senior Quality Assurance Associate

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Canada, Inc. is committed to providing patients, customers, community, and employees with a bright future by changing tomorrow. This commitment is made possible because we are a different kind of pharmaceutical company. Headquartered in Markham, Ontario, Astellas Pharma Canada, Inc. has been named on the list of Best Workplaces™ in Canada by the Great Place to Work® Institute for the seventh consecutive year in a row. For more information on Astellas, please visit our website at www.astellas.ca.

Astellas Pharma Canada is currently searching for a Senior Quality Assurance Associate reporting to the Senior Manager, Quality Assurance. This is a head office position located in Markham, Ontario.

Description

• Responsible for revision of SOPs, maintenance of Product Master Binders, Stability Binders and Validation Binders.
• Responsible for auditing batch documents and laboratory test results.
• Responsible for conducting some external site audits.
• Responsible for requesting samples for testing and for reserve inventory, and for product release according to Canadian GMP.
• Responsible for handling customer complaints and return goods procedures.

Essential Job Duties

1. Initiates and co-ordinates laboratory testing; audits and prepares batch document files from third party manufacturing facilities, approves and releases products.
2. Maintains the QA receiving log. Requests samples for QC testing and Retention.
3. Documents and responds to customer complaints, processes product returns and determines return goods status.
4. Maintains and updates all SOP files. Writes reviews and facilitates SOP revisions.
5. Maintains and updates Product Master Binders, Stability Binders and Validation Binders.
6. Conducts GMP inspections of Canadian sites as required.
7. Assists the QA Manager with auditing of manufacturing locations if required.
8. Provides assistance to the QA Manager during Health Canada GMP inspections.
9. Reviews validation summaries from manufacturers.
10. Discusses with QA Manager any potential issues related to the QA function and proposes possible solutions and appropriate corrective action plans.
11. Provides QA function for clinical supplies release for studies in Canada.
12. Assists QA Manager with Method Transfer activities.
13. Initiates deviation reports and conducts investigations as necessary
14. Participates in monthly complaint reconciliation meetings
15. Manages the change controls for assigned products.
16. Maintains QA documents in Astellas Document Management System (ADMS).
17. Performs other duties as assigned.

Required Qualifications

• Proficient in Microsoft Office.
• Thorough knowledge of GMP regulations and testing technology in chemistry and microbiology.
• Meticulous attention to detail.
• 3-4 years relevant work experience in the pharmaceutical industry.
• B.Sc. degree in chemistry, microbiology or life science.
• Excellent written and verbal communication skills are required, including French as asset.

If your skills and experience match our needs, please email your resume to: [email protected].

Astellas Pharma Canada requires full Vaccination against COVID-19 as a condition of employment. Reasonable accommodation to this policy may be granted for a valid accommodation request under human rights legislation.

Astellas Pharma Canada welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the hiring process.

No telephone inquiries, in-person applications, or agencies please. While we appreciate all applications, only candidates under consideration will be contacted.