Documentation specialist
Gdańsk
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 role:
The Manufacturing Science & Technology unit cooperates closely with the development scientists, manufacturing teams and third parties to achieve continuous improvements in the way the therapies are brought to the market. As an MS&T Documentation Specialist you will be responsible for keeping the documentation in accordance with the GMP requirements.
Your responsibilities:
- Keeping MS&T documentation in accordance with GMP requirements
- Preparation and updating of system documents, procedures and instructions as well as related documentation in accordance with GMP requirements
- Revision of protocols, reports, batch records and documentation related to manufacturing, technology transfer and process validation
- Close cooperation with the Quality Department
- Documents translation
- Supervision over the issuance and withdrawal of GMP documentation in the Technical Operations Department
- Ongoing reporting of the progress of work to the supervisor
- Supervision over the Training Records
If you have:
- Experience in working with documentation
- Higher education
- Good knowledge of the principles of cGMP good manufacturing practice
- Experience in conducting documentation investigations of deviations, CAPA and change control
- Very good command of English, both written and spoken
- Accuracy and meticulousness in carrying out tasks
- Experience in working with quality or process documentation, experience in biotechnological / pharmaceutical production is an advantage