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.