QC Stability Expert

Polpharma Biologics

Gdańsk

23 dni temu

#PolpharmaBiologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion. Together we develop medicine, offering new hope to patients suffering from serious diseases.

We create a passionate and friendly workplace environment. Join us!

 

 

WE ARE LOOKING FOR:
QC Stability Expert
Gdansk Science & Technology Park, Trzy Lipy 3
WHAT MAKES US SPECIAL
  • International work environment
  • Attractive salary
  • Cutting-edge technology equipment
  • Conferences and trainings around the world
You will take care of:
  • Being the main responsible person and expert for Stability Studies at Polpharma Biologics
  • Maintaining a stability study concept and procedure according to regulations, e.g. ICH guidelines
  • Preparation of all documents related to stability studies of biopharmaceuticals, e.g. study plans and reports
  • Supervision on assigned Stability testing staff members and their daily work activities including workload, ensuring training, general guidance to direct reports and across functional groups, and serves as resource for technical/administrative problems
  • Stability sample management, including logging in of samples, storing samples in environment chambers, coordinate periodic sample pull for testing and distribution of samples amongst the Quality Control Laboratory network, disposing of samples when stability testing is completed
  • Maintaining all original documentation related to the Stability Program, including creating study folders, generating test forms for monthly sample pull, filing all original test forms and any associated documentation in study folders, transfer filings of all completed study folders in accordance with the company’s document retention SOP
  • Initiating new stability studies
  • Performing trend analysis of results, identification of OOS/OOT test results and subsequent investigation
  • Participation or lead in documenting, investigating, troubleshooting and preventing recurrence of deviation
  • Representing Polpharma with clients and prospective clients
  • Participation and representation of Polpharma Biologics in internal/external audits.
If you have:
  • Higher education in biologics, chemistry, pharmacy, biotechnology or related,  supported by min. 2 years of work experience in the pharmaceutical industry,
  • Excellent knowledge of GMP requirements, pharmaceutical laws and regulations for pharmaceuticals, especially for biopharmaceutical drug substance and sterile products and stability studies
  • Knowledge of physicochemical, biological and microbiological methods
  • Minimum 2 years of laboratory experience (in regulated environment).
  • Fluent knowledge of spoken and written English
Join our Team!
We offer
  • Sport Card
  • Development programs
  • Private healtcare
  • Relocation package
  • Fruit day
  • Integrations events
  • Benefit platform
  • and more
Apply for the job
Contact us for details
Recruiter
Aleksandra Bufnal
aleksandra.bufnal@PolpharmaBiologics.com
Visit us
www.polpharmabiologics.com

Poznaj

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.

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