QC Stability Expert

Polpharma Biologics 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 medicines, offering new hope to patients suffering from serious diseases.

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

We are looking for:

QC Stability Expert

 

You will take care of:

  • Main responsible person and expert for Stability Studies at Polpharma Biologis
  • Maintaining a stability study concept and procedure according 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 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 healthcare
  • Relocation package
  • Fruit day
  • Integration events
  • Benefit platform
  • and more
Poznaj pracodawcę  
Polpharma Biologics S.A.
 

Polpharma Biologics S.A.

QC Stability Expert

 
Miejsce pracy: Polska, Pomorskie, Gdańsk
 
Umowa o pracę
   
Ważna jeszcze 0 dni (do 2019-08-19)
 
 

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