QA Equipment Validation Specialist
Duchnice
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 responsibilities:
  • Follow all Companies procedures and assure personal trainings are complete and up to date.
  • Active participation in development of system requirements and specifications to ensure that the requirements are testable and that the relevant regulatory requirements are met;
  • Review of all qualification documentation and assure compliance to Companies procedures
  • Assuring all pre-requisites and actively participating in follow-ups of all qualification activities related to equipment (both carried out internally and by external services) according to Companies procedures;
  • Participation in developing or reviewing quality system documentation;
  • Participation in investigations and associated corrective and preventive actions in area of responsibility;
  • Participation in the change control process;
  • Participation in internal and external audits and implementation of post-audit recommendations;
  • Designing and supporting implementation of continuous improvement initiatives.
If you have:
  • Understanding of electronic and mechanical principles (technical education and technical background is preferred).
  • Professional experience (Qualifications/Validation, Technical operations, QA, QC);
  • Knowledge of EU and FDA cGMP regulations, PIC/S guidelines, WHO guidelines, EDQM guidelines, standards and guidelines applicable to manufacturing and laboratory equipment (like ISPE, PDA, ISO);
  • Ability to communicate effectively internally within Validation team and with external teams (production, engineering, QC,…) as well;
  • Ability to set priorities and multi-task during peak demands;
  • Ability to clearly report and present results;
  • Ability to analyze the issue and provide effective solution;
  • Independent, pro-active, flexible team player;
  • Analytical: Proposing solutions for problems identified;
  • Methodical: working according to work practices of Company;
  • Good communication skills, both in writing and verbally;
  • Professional proficiency in MS Office.
Why you should work with us
Contact us
career@polpharmabiologics.com

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