Stability Scientist Vacature in Zuid-Holland 2300, Zuid-Holland Nederland

Job description

BSc(HBO)/MSc/PhD, Experience with stability studies in a pharmaceutical environment

Job description

You are responsible for completion of stability studies from implementation of study plans, obtaining samples from production area, documentation and labeling, studies initiation and running, overseeing performance, data review, to approval of final timepoint report. Tasks include, but are not limited to:

• Ensuring stability studies are conducted in full compliance with GMP and in accordance with Pharmaceutical ICH Guidelines, and pharmacopoeia requirements: samples are pulled within pull windows, tested using stability indication methods (validated/qualified), and results are assessed according to approved shelf-life specification


• Being knowledgeable of product specifications, of handling aberrant, out of specification, or out of trend results and related interactions with other disciplines
  


• Reviewing internal and external test results/raw data (on paper and in LIMS)


• Performing stability data interpretation and stability trending for products under stability program


• Handling of assay trending reports (e.g. accepting/rejecting target value, creation and approval/decline of trending reports, decide about follow-up), 


• Writing trending report with discussion and conclusion if trend is seen and make decision if continue the assay with specific material, or not


• Review of methods qualification and validation study plans and reports (Relevant experience in with analytical test methods of molecular and bioassays and analytical assays )


• Providing technical input to development team of stability indicative methods
  


• Writing new procedures, test instructions, equipment instructions


• Effectively contribute in process of improvements by successfully solving quality incidents (events/deviations/CAPAs/CC) in stability program


• Ensuring statistical analyses for stability reports 
  

Qualifications

• Relevant degree (BSc (HBO), MSc, PhD)


• 3-5 years of experience in design, management and reporting of stability studies, preferably in industrial/commercial environment working to GMP standards


• Knowledge of statistical analyses and data trending


• Eexperience in outsourcing of stability studies to third parties, experience in participation in project teams;


• Experience in design, management and reporting of stability studies for IND/IMPD/NDA;


• Experience with analytical methods qualification/validation


• Experience in participation in project teams


• Accurate, flexible, pro-active and capable to build good relations with all stakeholders.


• Capable of keeping the overview and to optimize processes in a dynamic, strong growing environment.


• Experience with lab activities in a GMP environment, where documentation plays a major role.


• High motivated, accurate, flexible, a good organizer, has a good sense for details while keeping overview and enjoys working in a team.
  

Zuid-Holland

Do you have experience with ustability testing in an industrial setting? Then this may be your next challenge!

Company

Our client a biotechnology company developing vaccines against infectious diseases.

Bezoek www.checkmark.nl voor meer informatie over de vacature Stability Scientist of solliciteer online op de vacature Stability Scientist.