TR&D QA Senior Specialist
Utrecht

Boost your career with us

Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.

Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!

Your role

If you are a Quality professional who enjoys working in dynamic environment and you are looking for a meaningful career opportunity where you would be responsible for implementation and improvement of aspects of Technical Research and Development (TR&D) Quality Assurance in a fast-growing biotech company, this role might be the right opportunity for you.   

In this role you will closely interact with the TR&D team, provide quality support for TR&D activities.  Further you will contribute to build a state-of-the-art Quality Assurance Function, participate in building and implementation of a global Quality Management System fit for purpose for TR&D.

Your responsibilities

  • close alignment with the Polpharma Biologics Group standards and Technical Research and Development Quality Module
  • Active support in preparation of the TR&D area for inspections and audits, participation in the audits/ inspections and quality support of follow-up activities  
  • Supervision and compliance with the GDevP rules and verification of documentation in TR&D areas in terms of compliance with the applicable internal procedures and current regulations
  • Contact with the TR&D and Quality Department of Polpharma Biologics to adapt the procedures and quality requirements to the standards of Polpharma Biologics 
  • Verification and approval of quality documentation in the area of Technical Research and Development 
  • Expert support in the assessment of cell line development and early process/analytical development project documentation; verification of project documentation 
  • Support in implementation of new guidelines, SOPs, good practices and solutions insuring traceability and data integrity in the area of TR&D 
  • Execution of internal control program 
  • Carrying out explanatory activities, root cause analysis and CAPA in the case of incidents and qualitative deviations in the area of TR&D 
  • Organizing and conducting quality training for the TR&D area 

If you have

  • Master’s or PhD degree in a relevant field (medicines, pharmacy, biotechnology, biochemistry, chemistry)
  • Over 5 years of experience in Quality Assurance in Biotechnological company (Cell line development or cooperation with CMO in the field of Cell line development or in GMP manufacturing of cell banks)
  • Experience in risk-based approaches
  • Deep knowledge of pharmaceutical quality system and data integrity requirements
  • Experience with quality audits and inspections
  • Deep knowledge of EMA, FDA and other relevant regulations
  • Strong skills and willingness to work and communicate cross-functionally and across sites  
  • Ability to work adapt to the company and local culture
  • Very good command of English language
  • Ability to cooperate with others to solve problems

We offer

Joining Polpharma Biologics means joining an international group of professionals working according to the latest technology standards. We foster a culture of growth and development and actively support you in achieving your career goals.

Join our Team!

Why you should work with us

Contact us
[email protected]