Quality Assurance Associate

Quality Assurance Associate

About Astellas:

At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focusing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.

We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn't a buzzword - it's a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.

We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes. Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.

The Opportunity

As the QA Affiliate, you will independently complete standard quality assurance activities in the affiliate. The position supports the Responsible Person and the QA Lead to meet his/her Responsibilities and Accountabilities. You will perform, record and process all standard, non-complex activities that are governed by Good Distribution Practice Guidelines (GDP Guidelines) as defined in the (global) Quality Management System.

At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver.

Key activities for this role:

1. Perform, record and process all standard, non-complex activities that are governed by Good Distribution Practice Guidelines (GDP Guidelines) as defined in the (global) Quality Management System (for example on QA oversight of Product Storage and Distribution, nonconformance management, product complaint handling, change control, supplier management and annual product review) and implement improvements to correct inefficiencies and non-conformances.
2. Support inspection management for the wholesale dealer license (or equivalent license), specifically during inspections and recalls.
3. Represent Affiliate QA in recurrent, non-complex local and global project teams, such as workflow training, onboarding training.
4. Perform initial QA acceptance and/or triage, but not final acceptance of all QA records (apart from product returns).
5. Act as a role model for the Quality Culture in the affiliate.

Essential Knowledge & Experience:

1. Relevant experience in a comparable role in the pharmaceutical industry (preferred).
2. Experience of implementation and understanding of GDP, GMP and Quality Management Systems preferred.
3. Fluency in written and spoken English.
4. Good organizational, coordination, presentation and communications skills.
5. Experience with Trackwise (Digital), Veeva and SAP systems (Preferred).
6. Experience with handling regulatory interfaces such as inspections and audits (Preferred).

Education:

1. Degree in a science/health-related subject.
2. Degree in pharmacy/certified pharmacist where applicable.

Additional information:

1. This is a permanent full-time position.
2. Hybrid working split - 1 day per week in the office.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.