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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.
- 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.
- 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.
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Polpharma Biologics
#PolpharmaBiologics to jeden z najnowocześniejszych ośrodków badań i rozwoju oraz produkcji leków biologicznych w Europie. Jesteśmy międzynarodowym zespołem doświadczonych ekspertów oraz ambitnych młodych naukowców posiadających wspólne cele i wartości. Biotechnologia jest naszą pasją, dzięki której wspólnie opracowujemy leki będące nadzieją dla pacjentów cierpiących na ciężkie choroby.
Razem tworzymy przyjazne miejsce pracy, w którym możemy się rozwijać oraz realizować swoje ambicje. Chcielibyśmy, abyś do nas dołączył.