Job Description

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 auditing batch documents and laboratory test results.
• 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.
• Responsible for revision of SOPs, maintenance of Product Master data.

• Responsible for conducting some external site audits.

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 documents, Stability Reports and Validation Reports.
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 and review deviation reports and conducts investigations as necessary.
14. Investigate and review complaint investigations.
15. Manage and assess the change controls for assigned products.
16. Maintains QA documents in Document Management System Veeva Vault.
17. Manage Drug Establishment License (DEL) and applications.
18. Act as the SME for SAP and TrackWie.
19.. Performs other duties as assigned.



Required Qualifications

• B.Sc. degree in chemistry, microbiology or life science.
• 3-4 years relevant work experience in the pharmaceutical industry.
• Thorough knowledge of GMP regulations and testing technology in chemistry

and microbiology.

• Excellent written and verbal communication skills are required, including French

as asset.

• Meticulous attention to detail.
• Proficient in Microsoft Office.
  

Additional Information

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.

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.

Application Procedure

If your skills and experience match our needs, please email your resume to:
employment@astellas.com.

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