TR&D Quality Assurance Specialist
Duchnice (pow. warszawski zachodni)

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

Participate in Quality Management System (QMS) building in Technical and Development Department (TR&D) in Duchnice site. Ensure that procedures prepared on site are aligned with TR&D Quality Module, relevant requirements defined in Polpharma Biologics as well as EMA, FDA and other relevant guidelines. Monitor the QMS implementation in TR&D Duchnice by on-site quality audits and trainings.  Perform and advise TR&D on risk assessments.

Your responsibilities

  • Implementation and monitoring of the quality system in the TR&D Department
  • Support in preparation of the TR&D area for inspections and audits, participation in the audits/ inspections and support of follow-up activities
  • Verification of documentation in TR&D areas in terms of compliance with the applicable internal procedures and current regulations
  • Contact with the TR&D 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 Research and Technical Development
  • Expert support in the assessment of process development project documentation; verification and approval of project documentation in the areas of USP and DSP process development
  • Implementation of new guidelines, good practices and solutions improving data integrity in the area of TR&D
  • Maintaining an 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
  • Revision of the audit trails from process and analytical laboratory equipment to ensure data integrity is maintained within computerized systems, actions adjusted to the stage of development

If you have

  • Master’s or PhD degree in a relevant field (pharmacy, biotechnology, biochemistry, chemistry)
  • Very good knowledge of spoken and written English
  • Knowledge of issues related to the pharmaceutical quality system
  • Knowledge of MS Office
  • Experience in working in an analytical, biotechnological and / or quality control laboratory in biotechnology or pharmaceutical companies
  • Knowledge of data integrity
  • Good organization of work and time
  • Ability to cooperate with others to solve problems
  • A minimum 2 year of experience in a similar position within Technical Research and Development, Quality Control, Quality Assurance or GMP regulated industry
  • A minimum 3 years of experience within the biotechnological manufacturing/research
  • Knowledge of GMP requirements and pharmaceutical laws and regulations related to pharmaceuticals
  • Knowledge of Quality Management Systems
  • Knowledge of Quality Risk Management/ risk based approach
  • Problem-solving orientation
  • Knowledge in the concept of the data traceability and integrity
  • Experience with computer systems validations and laboratory equipment qualification will be an advantage
  • Knowledge of regulations and guidelines contained in the ICH, FDA, EMEA and national guidelines
  • Strong verbal and written communication skills (including Polish and English languages), good time management skills
  • Ability to work with MS Office

We offer

  • Private healthcare;
  • Life insurance;
  • Pension plan above national standards;
  • Relocation package;
  • Additional free day;
  • and more…
Join our Team!

Why you should work with us

Contact us
[email protected]