Quality Assurance Spe­cial­ist

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.
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 caregivers, 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.

About This Job:

The QA Specialist is part of a small team reporting the QA Lead/Responsible Person for the Nordics Affiliate. The role will have responsibility for managing the quality management systems (QMS) as well as working directly with the QA Lead across a broad range of QA activities, ensuring all Astellas products, personnel and third parties conform to local, European and company quality assurance requirements. This is a great opportunity for someone with experience in QA to grow and develop and deputise for the QA Lead in their absence.

Key activities are noted below:

  • Maintain the QMS in respect of procedures and processes such as handling deviations, complaints and CAPAs and Good Manufacturing Practice (GMP)/ Good Distribution Practices (GDP), regulated changes or escalations of potential quality issues.
  • Ensure deviations, complaints, CAPAs and change control actions are progressed in a timely manner
  • Perform local checks following receipt of certified medicinal product and execute the local “Release for Distribution” for products
  • Check/prepare quality agreements with local country third parties in accordance with internal and external regulations.
  • Perform audits of local country third parties and conduct self-inspections
  • Ensure local GMP / GDP procedures are maintained in the Astellas Document Management Systems (ADMS)
  • Ensure QA requirements are followed and maintain oversight for GDP operations and warehouse management
  • Document changes with potential impact on GDP/GMP compliance, implementing the changes within the agreed timelines and perform validation activities for local GDP/GMP systems
  • Prepare for GDP/GMP Inspections and QA Internal audits
  • Produce monthly KPI report and submit to QA Sub-region lead
  • Review Product Quality Reports (PQRs) against defined procedures.

In assuming deputy QA Lead/RP activities when required:

  • Ensure standards of GDP/conditions are maintained during product distribution activities, including storage and transport of cold chain, ambient and hazardous products
  • Ensure any recall operation is performed promptly, coordinating with RQA, marketing authorization holders and national competent authorities

Essential Knowledge & Experience:

  • Experience of Quality Assurance from within the pharmaceutical industry
  • An understanding of EU GDP, GMP and Quality Management Systems
  • Experienced in handling regulatory interfaces such as inspections and audits is an advantage
  • Fluent in verbal and written English, able to communicate/negotiate effectively with internal stakeholders & external authorities/suppliers
  • Precise, organised, rigorous and reliable with an analytical mind
  • Good decision-making skills
  • Systems literate

Education/Qualifications:

  • Degree in a science/health-related subject.

What we offer:

  • This is a full-time permanent position based in the Denmark

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.

Gem job

Astellas Pharma A/S
Publiceret: 20 December 2021

Arbejdssted

Copenhagen