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 QA Associate, you will play a critical role in ensuring the quality and compliance of pharmaceutical distribution activities in alignment with global and local regulations. This position provides a unique opportunity to develop expertise in Good Distribution Practice (GDP) while supporting key quality processes across the affiliate. You will work closely with cross-functional teams and contribute to maintaining a strong quality culture that supports safe and effective product distribution.
Hybrid Working:
At Astellas we recognise the importance of balancing your work and home life. This role offers a remote working solution so you can optimise the most productive work environment for you to succeed and deliver.
Responsibilities and Accountabilities:
- Carrying out, documenting, and processing all standard, non-complex activities governed by Good Distribution Practice (GDP) Guidelines, as defined in the global Quality Management System—this includes QA oversight of product storage and distribution, nonconformance management, product complaint handling, change control, supplier management, and annual product review—while also implementing improvements to correct inefficiencies and address non-conformances.
- Supporting the management of inspections related to the wholesale dealer license (or equivalent license), specifically during regulatory inspections and product recalls.
- Representing Affiliate QA in recurring, non-complex local and global project teams, such as those focused on workflow training and onboarding training.
- Performing initial QA acceptance and/or triage of all QA records, except for final acceptance, which is only applicable in the case of product returns.
- Acting as a role model in upholding and promoting the Quality Culture within the affiliate.
Essential Knowledge and Experience:
- Relevant experience in a comparable role in the pharmaceutical industry preferred.
- Experience of implementation and understanding of GDP, GMP and Quality Management Systems preferred.
- Fluency in written and spoken English.
- Good organisational, coordination, presentation and communications skills.
Preferred Experience:
- Experience with eQMS, Trackwise (Digital), Veeva and SAP systems.
- Experience with handling regulatory interfaces such as inspections and audits.
Education:
- BSc Biology, Chemistry, or Pharmacy or equivalent.
- Degree in pharmacy/certified pharmacist where applicable.
Working Environment:
- The is a permanent full-time position based in the UK.
- This position follows our hybrid working model. Role requires a blend of home and minimum of twice per month in our Addlestone office. Flexibility may be required in line with business need. 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.
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