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!
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.
Poznaj
Rezon Bio
Dołącz do zespołu ponad 1300 specjalistów produkujących zaawansowane leki biologiczne, które poprawiają jakość życia pacjentów na całym świecie.
Bazując na doświadczeniu Polpharma Biologics, Rezon Bio działa jako partner CDMO (Contract Development and Manufacturing Organization).
Dzięki nowoczesnym centrom biotechnologicznym w Gdańsku i Warszawie-Duchnicach oferujemy szeroki wachlarz możliwości karierowych w obszarach naukowych, technicznych i biznesowych.