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:
Documentation Specialist’s role is to participate in the process of supervision, control and revision of the quality documentation related to the activities carried out in the Microbiological Production Department, in accordance with the GMP rules and FDA requirements.
Your responsibilities:
- Supervision and preparation on the documentation in Technical Operation Department - Microbial Plant (batch records, protocols, reports);
- Conducting a Technical Operations documentation review according to GMP/FDA requirements;
- Preparation and verification of system documents, procedures and instructions and related documentation in accordance with GMP/FDA requirements;
- Supporting trainings for personnel (GMP requirements, Data Integrity, Good Documentation Practice);
- Supporting preparations for inspections, external and internal audits;
- Supporting investigations, root cause analysis of deviations and change controls and CAPA activities;
- Additional task as required by the business needs.
If you have:
- Experience in working with documentation;
- Knowledge of quality management systems;
- Higher education;
- Very good command of English, both written and spoken;
- Very good knowledge of MS Office;
- Knowledge of GXP requirements is an advantage;
- Experience in working with quality or process documentation, experience in biotechnological / pharmaceutical production is an advantage;
- Ability to solve problems independently;
- Good organization of work and time;
- Accuracy and meticulousness in carrying out tasks;
- Flexibility for new tasks, communication skills, ability to work in a team.