Abbott Quality Services Specialist – Stability Studies in Weesp, Netherlands
Abbott Established Pharmaceuticals Division (EPD) is looking for a Quality Services Specialist – Stability Studies based in The Netherlands, Weesp. This Quality Services Specialist – Stability Studies is part of the Site Quality Services Team and reports into the Quality Services Manager. He or she is the expert in the area of stability studies to support EPD quality, regulatory and technical functions worldwide and is part of the Center of Excellence for reference standards, stability, and compendia compliance.
Are you a quality minded (junior) scientist who likes to coordinate projects? Are you strong in writing procedures/reports and looking for a next step in your career? Do you have continues improvement mentality embraced? Do you want to contribute to ensuring reliable expiration date setting for a number of Abbott Products within different climate zones for specific countries? Please apply!
Quality Services Specialist – Stability Studies
Initiation, management and reporting of stability studies for EPD products, intended for regulatory purposes to support new/renewed product submissions and market expansion. Compile relevant parts of registration dossier.
Technical expert support for assessment of events of temperature excursions of pharmaceuticals during transportation.
Compile relevant parts of registration dossier.
At minimum a Bachelor's degree in Chemistry, Life science or equivalent.
Minimum 3-5 years in a laboratory position in the pharmaceutical or food industry, with broad knowledge of and experience with analytical techniques.
Experience with data systems and statistical programs (SAP or LIMS /SPSS).
Experience in coordination (i.e. validation/stability/development/equipment related).
Experience in writing (GMP) protocols and reports.
Demonstrates strong project management skills and the proven ability to manage projects
Broad knowledge and expertise on pharmaceutical business and a good overview of all aspects involved
Strong focus on customer, quality and compliance
Structured thinking and scientific report writing skills
Make problems visible & strive for Continuous Improvement
Good organizational and planning skills
Collaboration, Decisiveness, and Persuasion
Anticipate, Innovate, Build, Deliver Results
Autonomous, assertive with an eye for details
Fluent in both the Dutch and English language
EPD Established Pharma
Netherlands > Weesp : WWA A-C-D
SIGNIFICANT WORK ACTIVITIES:
Keyboard use (greater or equal to 50% of the workday)
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