Validation Specialist / Specjalista Walidacji
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!
Validation Specialist is responsible for supporting of process validation, cleaning validation and transport validation activities in accordance with Regulatory requirements.
Your main responsibilities include, but are not limited to:
- Participation in development of pre-validation / validation strategy, including the strategy for supportive studies;
- Supporting of coordination of activities between all departments involved in individual activities of drug substance manufacturing process validation, cleaning validation and transport validation;
- Creation of validation plans, protocols and reports;
- Supporting of initiation of the monitoring and continuous process verification phase and compilation of the first APQR;
- Supporting the creation of production documents necessary for process validation (main technological instruction, manufacturing instructions, batch records and others);
- Participation in preparations for and in the inspections of pharmaceutical regulatory authorities;
- Participation in the development and updating of procedures and documentation templates as part of process, cleaning and transport validation;
- Informing direct supervisor about all abnormalities in process, documentation, progress of tasks and decisions.
- Reporting the work progress and tasks status to supervisor;
- Report preparation of performed tasks;
- Cooperation with all groups from site and Polpharma Biologics group;
- Work organizing and impact on the work of others in order to make the most effective use of working time and performance of tasks;
- Worthy of representing the company;
- Supervisor command execution related to this function;
- Conducting training courses on the created documents and participation in obligatory training.
If you have:
- Higher education in the field: biotechnology, pharmacy or related;
- Experience in working with recombinant proteins;
- Very good command of the English language;
- The ability to organize work well and to cooperate in a team;
- Ability to identify and solve problems independently;
- Very good knowledge of MS Office;
- Written and spoken fluency in English.
What we offer:
- Competitive salary;
- Private healthcare;
- Life insurance;
- Pension plan above national standards;
- Relocation package;
- Additional free day;
- And more..