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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
Poznaj
Rezon Bio
Dołącz do zespołu ponad 1300 specjalistów produkujących zaawansowane leki biologiczne, które poprawiają jakość życia pacjentów na całym świecie.
Bazując na doświadczeniu Polpharma Biologics, Rezon Bio działa jako partner CDMO (Contract Development and Manufacturing Organization).
Dzięki nowoczesnym centrom biotechnologicznym w Gdańsku i Warszawie-Duchnicach oferujemy szeroki wachlarz możliwości karierowych w obszarach naukowych, technicznych i biznesowych.