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Quality Assurance

3 months ago


Addlestone, Surrey, United Kingdom Astellas Europe Full time

Quality Assurance Specialist - Exciting Opportunity

About Astellas:

At Astellas, we pride ourselves on being a forward-thinking health partner, dedicated to delivering value and impactful outcomes. Our focus is on cutting-edge science, addressing critical areas with a high patient demand. We collaborate with patients, doctors, and healthcare professionals to ensure that our development efforts are driven by genuine clinical needs. Patient Centricity is at the core of our global vision, guiding us to create innovative health solutions rooted in a deep understanding of the patient experience.

The Role:

Join us as a Quality Assurance Specialist at Astellas where your contributions are vital to fortifying and enhancing the pharmaceutical quality management system. Working closely with stakeholders, you will ensure adherence to local, European, and internal quality standards. Your role will involve acting as a Deputy Responsible Person as per EU GDP guidelines and overseeing Quality Assurance activities for the Affiliate and third parties.

Flexible Working Environment:

Recognizing the importance of work-life balance, we offer a hybrid working solution at Astellas. This model allows you to engage face-to-face with colleagues when needed at the office while providing the flexibility to work remotely, enabling you to thrive and deliver results in the most conducive work environment.

Your Responsibilities:

  • Maintain and enhance the Quality Management System by implementing processes and procedures.
  • Investigate deviations and complaints, developing CAPA plans as required.
  • Perform local checks for certified medicinal products and oversee product distributions in compliance with regulations.
  • Handle quality agreements with third parties, conduct audits, and act as a Deputy Responsible Person ensuring GDP standards.
  • Conduct Self-inspections, prepare for audits, and assist during inspections by Health Authorities.
  • Generate and submit monthly KPI reports for review.

Requirements:

  • Background in the pharmaceutical industry.
  • Proficiency in written and spoken English.
  • Familiarity with EU GDP, EU GMP, and Quality Management Systems.
  • Strong communication and negotiation skills.

Desired Experience:

  • Experience with regulatory inspections and audits.
  • Excellent organizational, coordination, and communication abilities.
  • Proficient in computer literacy with strong decision-making skills.

Education:

  • Minimum Bachelor's degree.

Additional Details:

  • Permanent, full-time position located in the United Kingdom.
  • Hybrid working model, requiring occasional visits to the Addlestone office.
  • Flexibility may be needed based on business requirements.

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