QA Associate

Astellas Pharma Inc.; United Kingdom; Hybrid; GBP 30,000 - 45,000; Full time

Job summary

A global pharmaceutical company is looking for a QA Associate in the United Kingdom. This full-time position involves ensuring the quality and compliance of pharmaceutical distribution activities in line with regulations. The role offers a hybrid working model, requiring in-office work in Addlestone at least twice a month. Applicants should have relevant experience in the pharmaceutical industry, a degree in a related field, and fluency in English.

Qualifications

• Relevant experience in a similar role within the pharmaceutical industry preferred.
• Understanding of GDP, GMP, and Quality Management Systems preferred.
• Fluency in written and spoken English is essential.

Responsibilities

• Carry out QA oversight of storage and distribution activities.
• Manage inspections related to wholesale dealer licenses.
• Represent Affiliate QA in local and global project teams.

Skills

Organizational skills

Coordination skills

Presentation skills

Communication skills

Education

BSc in Biology, Chemistry, Pharmacy, or equivalent

Degree in pharmacy or certified pharmacist

Tools

Trackwise

Veeva

SAP systems

Job description

QA Associate at Astellas

About Astellas: At Astellas, we are a progressive health partner dedicated to delivering value and outcomes. We focus on innovative science, especially in areas of high patient need, including rare or underserved diseases and life-threatening conditions. We collaborate closely with patients, healthcare professionals, regulatory authorities, and payers to develop and ensure access to meaningful therapies, supporting a patient-centric culture across our organization.

The Opportunity: As a QA Associate, you will ensure the quality and compliance of pharmaceutical distribution activities in line with global and local regulations. This role offers a chance to develop expertise in Good Distribution Practice (GDP) and support key quality processes within our affiliate. You will work with cross-functional teams to maintain a strong quality culture that ensures safe and effective product distribution.

Hybrid Working: We support work-life balance by offering remote work options, allowing you to work from home and in our Addlestone office at least twice a month, with flexibility based on business needs.

Responsibilities and Accountabilities:

1. Carry out, document, and process standard, non-complex activities governed by GDP guidelines, including QA oversight of storage and distribution, non-conformance management, complaint handling, change control, supplier management, and annual reviews, while implementing improvements.
2. Support management of inspections related to wholesale dealer licenses, especially during regulatory inspections and product recalls.
3. Represent Affiliate QA in local and global project teams focused on workflow and onboarding training.
4. Perform initial QA acceptance and triage of QA records, excluding final acceptance for product returns.
5. Promote and uphold the Quality Culture within the affiliate.

Essential Knowledge and Experience:

• Relevant experience in a similar role within the pharmaceutical industry preferred.
• Understanding of GDP, GMP, and Quality Management Systems preferred.
• Fluency in written and spoken English.
• Strong organizational, coordination, presentation, and communication skills.

Preferred Experience:

• Experience with eQMS, Trackwise (Digital), Veeva, and SAP systems.
• Experience handling regulatory inspections and audits.

Education:

• BSc in Biology, Chemistry, Pharmacy, or equivalent.
• Degree in pharmacy or certified pharmacist where applicable.

Working Environment:

• This is a permanent, full-time position based in the UK.
• Follows a hybrid working model, requiring a mix of home and at least twice monthly in-office work at Addlestone. Flexibility may be needed based on business demands. Candidates should be within commuting distance of the office.

We are an equal opportunity employer, and all qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, disability, veteran status, or other legally protected characteristics.