QC Senior Scientist

Beschreibung

Senior Scientist QC Analytics and Stability Studies

Our biopharmaceutical client is currently undergoing preparations for a pre-approval audit. They are looking for an experienced QC Specialist to support them in the review of their stability study program and QC documentation.

Duration: 12 months
Location: Düsseldorf Area, Germany

Job and Project Description
• Manage revision of Stability Study Program
• Prepare stability study statistical analysis and stability study
reports
• Lead investigations on Deviations and OOS results
• Prepare and review Deviation, CAPA and Change Control documents
• Prepare and review SOPs on test methods and other procedures
relevant to QC
• Prepare and/or review QC protocols and reports

Requirements
• Degree in life science / biochemistry / pharmaceutical sciences or
relevant experience.
• Strong experience in biologics, QA and stability study management
• Strong cGMPs knowledge and regulatory requirements for testing and
stability
• Broad experience with analytical techniques including, but not
limited to SDS PAGE, ELISA, HPLC

Skills
• Fluent German and English
• Excellent communication, interpersonal and training skills
• Excellent technical writing skills and experience in writing SOPs
• Proven ability to establish collaborative working relationships;
team-oriented and must be able to work independently
• Excellent ability to prioritise and manage multiple projects
and tasks
• Personal attributes include flexibility, integrity, action- and
goal-oriented