General Information

Job Advert Title
Quality Assurance Specialist
Location
Denmark
Function/Business Area
Quality
Department
Quality Assurance
Employment Class
Permanent

Description

About Astellas:


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 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 minds together and provide world-leading tools and resources in a unique structure that fosters real agility and entrepreneurial spirit.


About This Job:


The Quality Assurance (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
  • Effectively deal with customer complaints, informing the manufacturer and/or marketing authorization holder of any product quality/defect issues
  • Undertake due diligence, overseeing Quality agreements are in place requiring storage areas, transport vehicles/equipment are of suitably temperature mapped, qualified and monitored
  • Disposition returned, rejected, recalled stock and ensure medicinal products are safe/secure from receipt to distribution.


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.


Additional information:


  • This is a full time permanent position based in 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.