Quality Assurance - United Kingdom

Quality Assurance - United Kingdom

About Astellas:

At Astellas we are a progressive health partner, delivering value and outcomes where needed. 

We pursue innovative science, focussing 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 a Quality Assurance Specialist at Astellas, your role is essential in further establishing, maintaining, and implementing the pharmaceutical quality management system. You will collaborate closely with various stakeholders to ensure compliance with local, European, and company Quality Assurance requirements. Additionally, you will act as a deputy Responsible Person as defined in EU GDP guidelines, performing.

Quality Assurance activities on behalf of the Affiliate and ensuring the quality management of third parties. Your responsibilities encompass maintaining the Quality Management System, overseeing deviations and complaints, conducting self-inspections, and preparing for GDP/GMP inspections by Competent Authorities.

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.

Responsibilities:

• Maintain the Quality Management System by implementing and continually improving QM systems, procedures, and processes.
• Ensure that deviations and complaints are appropriately investigated and CAPA plans are developed where necessary.
• Perform local checks following receipt of certified medicinal product and execute the local “Release for Distribution" for products in accordance with local regulations.
• Check and prepare quality agreements with local country third parties and perform audits of local country third parties as appropriate.
• Act as Deputy Responsible Person in the absence of the QA Lead & Responsible Person, ensuring appropriate standards of GDP and conditions are maintained during product distribution activities.
• Perform Self inspections, prepare for Internal QA audits and Health Authority GDP inspections, assist the Quality Assurance Lead & Responsible Person during these audits/inspections.
• Prepare monthly KPI report, ensure approval of the KPI report by the Quality Assurance Lead & Responsible Person, and submit the KPI report to the QA Sub-region lead.

Essential Knowledge & Experience:

• Previous work experience in the pharmaceutical industry
• Fluency in written and spoken English.
• Understanding of EU GDP, EU GMP,
• Prior experience using Quality Management Systems.
• Ability to communicate and negotiate effectively with peers.

Preferred Experience:

• Experience in handling regulatory interfaces such as inspections and audits.
• Strong organizational, coordination, diplomatic, negotiation, and communication skills.
• Computer literacy and analytical mindset with good decision-making skills.

Education:

• Bachelor’s degree or equivalent

Additional information:

• This is a permanent, full-time position
• Position is based in the United Kingdom
• This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter at our Addlestone 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.