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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.
- 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
- 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
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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.