Polpharma is an international pharmaceutical company which operates in the markets of Central and Eastern Europe, the Caucasus and Central Asia. For more than 75 years we have been trusted by patients, healthcare professionals and business partners. The company specializes in cardiology, neurology and gastroenterology prescription and hospital use drugs. Apart from that Polpharma produces many OTC drugs. Currently the company is making massive investments in the development of new biotechnology drugs, both innovative and bioequivalent.
Currently we are looking for:
Validation Expert
Location: Gdańsk
Responsibilities:
- Lead all facility, equipment and process qualification/validation efforts
- Support process transfers and validation activities
- Plan and co-ordinate all validation activities in line with facility requirements
- Lead all trouble-shooting activities and deviation assessments as required
- Interact with internal and external collaborators as appropriate
- Ensure that all activities comply with appropriate pharmaceutical and biotech regulations e.g. ICH, EMA and FDA
Experience Required:
- BSc of higher in Biotechnology or related disciplines
- A minimum of 5 years in a biologics GMP regulated environment
- Experience in facility equipment qualifications and re-qualifications
- Experience of biological process transfer and validation
- Experience of disposable bioreactor technologies an advantage
- Experience working in an international environment is an advantage
- Good knowledge of current GMP standards
- Good Communication skills
- Good knowledge of English
Successful candidate will be offered:
- Helping to create a successful Polish biotech company
- Work in a cutting edge biotech laboratory
- Being part of a team developing biologic drugs for clinical and commercial applications
- Great opportunity for professional development
- Benefits package and incentive pay, based on experience
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.