Quality Assurance Associate

Astellas; Addlestone; Hybrid; GBP 40,000 - 60,000; Full time

Job summary

Join a forward-thinking pharmaceutical company dedicated to making a meaningful difference in patients' lives. This role as a QA Affiliate offers the opportunity to engage in critical quality assurance activities, ensuring compliance with Good Distribution Practice guidelines. You will collaborate with teams to foster a patient-centric culture while utilizing innovative tools and resources. The hybrid working model allows for flexibility, balancing office presence and remote work, making it an ideal opportunity for those looking to thrive in a supportive and inclusive environment. If you're passionate about quality assurance in the pharmaceutical industry, this role is perfect for you.

Qualifications

• Experience in QA activities and understanding of GDP and GMP.
• Degree in a science/health-related subject required.

Responsibilities

• Perform quality assurance activities governed by GDP guidelines.
• Support inspection management and represent QA in project teams.

Skills

Quality Assurance

Good Distribution Practice (GDP)

Good Manufacturing Practice (GMP)

Organizational Skills

Communication Skills

Trackwise

Veeva

SAP

Education

Degree in a science/health-related subject

Tools

Trackwise

Veeva

SAP

Job description

At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.

Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society.

Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.

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.

Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.

We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership.

Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.

The Opportunity:

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

Hybrid Working:

At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver.

Key activities for this role:

1. Perform and process 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 with inspection management for the wholesale dealer license (or equivalent license), specifically during inspections and recalls.
3. Represent Affiliate QA in recurrent, local and global project teams, such as workflow training, onboarding training.
4. Act as a role model for the Quality Culture in the affiliate.
5. Demonstrate relevant transferable skills in a comparable role in the pharmaceutical industry (preferred).
6. Have an understanding of implementation and understanding of GDP, GMP and Quality Management Systems.
7. Possess good organizational, coordination, presentation and communication skills.
8. Have experience with Trackwise (Digital), Veeva and SAP systems (preferred).
9. Have knowledge of handling regulatory interfaces such as inspections and audits (preferred).

Education:

1. Degree in a science/health-related subject or equivalent.

Additional information:

1. This is a permanent, full-time position.
2. This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per week in our local office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of 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.