Astellas is a top 20 global pharma company with 4 regions covering Japan, North America, International and Established Markets (EST) with a commitment to innovative medicines and value for patients. The organisation employs more than 17200 people worldwide, 4700 people in EST-C and 140 people in the Nordics. Key therapeutic areas of focus are Oncology & Specialty Medicines
Are you ready to take the next step in your career? We are looking for a driven Quality Assurance Specialist!
The Role
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 responsibilities but not limited to:
- 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.
Your profile
- 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
You are social and a good communicator, organized, adaptive and not afraid of responsibilities. We are looking for a team player, who is able to work independently and within a team and manage multiple activities.
You must be able to identify with the Astellas core values and the individual elements: Success driven, Team oriented, Adaptable, Respectful and behave accordingly. Relevant academic education. Ideally a Degree in Pharmacy or other Life Science subjects or equivalent by experience.
Welcome with your application as soon as possible. Interviews are ongoing and the employment can be filled before the application deadline.
For more details, please contact Peter Ek: +46 733 23 47 51 or peter.ek@carpenova.se
Welcome!