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Senior Quality Assurance Associate

Astellas Canada – People Operations Partner

At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients.

What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people.

Making a positive impact on patients’ lives is the purpose behind everything we do. At Astellas, we are relentless in our pursuit of scientific progress and in tackling unmet medical needs, demonstrated by our legacy in oncology, overactive bladder and transplant and our impressive pipeline in women's health, blindness and regeneration, genetic regulation, immuno-oncology, mitochondria and targeted protein degradation.

About Us:

We are a global pharmaceutical company headquartered in Japan, with a team of more than 14,000 managing operations in approximately 70 countries around the world. We are in the Top 30 global biopharma company based on global revenues and are predicted to be one of the Top 10 Cancer Drug Makers of 2024 by Fierce Pharma.

In Canada, we are growing to meet the exciting opportunities realized by our legacy brands and rich pipeline of innovative treatments.

We are looking for candidates who will thrive in our entrepreneurial and empowering environment where talent and leadership flourish. Do your values align with our Astellas Way - patient focus, ownership, results, openness, and integrity? Then we would love to hear from you.

From the first day in role, everyone at Astellas has a responsibility for creating a brighter future for patients around the world. We nurture exceptional relationships with our employees to allow them to thrive, foster innovation, and deliver exceptional business results. We work to create a culture where our people feel empowered to pursue brave ideas and ambitious outcomes, to have the confidence to be accountable for a higher standard of performance and embody a competitive and solutions-oriented mindset.

Our expertise, science and technology make us a pharma company. Our open and diverse culture is what makes us uniquely Astellas.

Astellas Pharma Canada (APCA) is currently searching for a Senior Quality Assurance Associate reporting to Head, Quality Assurance, Established Mid-Sized Markets Canada.

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.

• Responsible for conducting some external site audits.

Essential Job Duties:

• Initiates and co-ordinates laboratory testing; audits and prepares batch document from third party manufacturing facilities, approves and releases products.

• Requests samples for QC testing and Retention.

• Documents and responds to customer complaints, processes product returns and determines return goods status.

• Maintains and updates all SOP records.

• Writes reviews and facilitates SOP revisions.

• Conducts GMP inspections of Canadian sites as required.

• Participates in auditing of manufacturing locations if required.

• Provides assistance during Health Canada GMP inspections.

• Reviews validation summaries from manufacturers.

• Discusses with line manager any potential issues related to the QA function and proposes possible solutions and appropriate corrective action plans.

• Provides QA function for clinical supplies release for studies in Canada.

• Manage Method Transfer activities.

• Initiates deviation reports and conducts investigations as necessary.

• Participates in monthly complaint reconciliation meetings.

• Manages the change controls for assigned products.

• Performs other duties as assigned.

This position will be hybrid, spending 50% in office with 50% of time working from home

Quantitative Dimensions:

• Timely release of products.

• Assisting with maintaining GMP Compliance.

Organizational Context:

• Reports to Head, Quality Assurance, Established Mid-Sized Markets & Canada

• Individual Contributor.

• Interacts with AUST colleagues.

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, SAP and Trackwise

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.

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

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Category

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans