Polpharma Biologics is part of the Polpharma Group, one of the largest pharmaceutical companies in Central and Eastern Europe. We focus on the development and production of biological medicines. Our international team consist of experiences experts and young scientists. We share common goal - to improve the quality of patients' ;ife with more availabe biological medicines of the hishest quality.
Documentation Coordinator
Location: Gdańsk
If you want to work:
- in one of the most modern biotechnology centres in Europe
- in a place where professionals from all over the world work on the highest-quality equipment
- in the production of biotechnological drugs, which give access to effective therapy to more patiens
- in a company that will give you stable employment, competitive renumerations, attractive benefits and the opportunity to participate in trainings at home and abroad
Currently we’re looking for
1
Documentation Coordinator
Join “start-up” Biologics division with strong international and local team at site!
We are waiting just for you!
What will you do?
- Supervision and coordination of the Documentation Team and ensuring quality compliance within the Technical Operations Department
- Supervision of the aforementioned Department’s documentation, adaptation of procedures and system documentation to the user’s needs while meeting GMP requirements
- Supervising and coordinating preparation and updating of system documents, procedures, instructions and related documentation in accordance with GMP requirements
- Conducting and / or supervising training sessions for employees
- Participation in internal audits, inspections, audits of service providers and material providers related to the production of both active substance and finished product
- Supervision and participation in the preparation of calibration, qualification, maintenance, preventive or repair schedules
- Supervising timely implementation of CAPA activities, tasks related to controlling changes and processing deviations
- Supervision of hygiene in production, technical and storage areas
- Participation in risk analysis and risk analysis planning
What do we expect?
- Higher education with specialisation in the fields of biotechnology, biology, pharmacy or related
- Min. 5 years of experience working with GMP documentation in pharmaceutical or biotechnological company
- Min. 3 years of practical experience working with deviations, CAPA, change control, creation of quality documentation, revision of process documentation or other documentation
- Min. 2 years of experience in team management role
- Good knowledge of cGMP and FDA requirements
- Experience in GMP / FDA audits / inspections and other audits/inspections
- Very good command of English in speaking and writing
- Experience working with biological drugs and experience in the use of disposable materials for the production of biotechnology drugs will be considered an additional asset
Poznaj
POLPHARMA S.A.
Zdrowe jutro zaczyna się od ludzi, którzy tworzą Polpharmę – od ich wiedzy, zaangażowania i pasji. Wspólnie dbamy o zdrowie innych i tworzymy środowisko, w którym każdy może być sobą. Rozwijamy się w zgodzie z własnymi ambicjami, niezależnie od obszaru, w jakim działamy. Razem z nami możesz realnie wpływać na zdrowie i dobrostan innych.