JWe are the largest manufacturer of medicinal products and a leader of the pharmaceutical market. We operate on the markets of Central and Eastern Europe, the Caucasus and Central Asia, and we employe over 7000 people in Poland and abroad. The portfolio of Polpharma Group covers around 600 products, including life-saving medicines. "People Help People" is our motto.
GMP Documentation Expert
Location: Duchnice (pow. warszawski zachodni)
We offer:
- Fixed renumeration
- Employment contract
- Private medical care
- Training courses
- Holidsy gifts
- Sports card
- Additional insurance
- Relocation package
How we work and who we work with
- Flexible working hours
- Team work
- Over 7,000 employeesw
What job will you do?
- participation in the design process of the production area and implementation of GMP system in documentation
- responsibility for the keeping and review process documentation and project documentation according to GMP requirements
- participation in technology transfer in accordance with cGMP regulations and internal during the implementation of projects related to the introduction of new biotechnology products
- manufacture of biotechnology products in accordance with GMP principles and FDA requirements to obtain a product of specified quality in the specification
- participating in audits of suppliers of services and materials related to the production
- supervision over schedules related to the preparation of GMP documentation in the production department - e.g. procedures, qualification documents, etc.
- running and/or supervising training for employees of the production department
What do we expect from you?
- master's degree in the fields: biotechnology, pharmacy or related
- at least 2 years’ experience in a similar position in biotechnology production or pharmaceutical industry
- excellent knowledge of cGMP and FDA requirements
- experience in keeping and review process documentation and project documentation according to GMP requirements
- experience in the use of disposable materials for the production of biotechnological drugs will be an advantage
- experience in conducting the investigations and documenting the deviations, CAPA and change control
- fluent English spoken and written
- strong communication and team cooperation skills and being open for new tasks are required
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.