Description
Senior Scientist QC Analytics and Stability StudiesOur 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: 1 year
Location: Düsseldorf Region, Germany
Job and Project Description
• Manage revision of Stability Study Program
• Prepare stability study statistical analysis and stability study reports
• Review of analytical raw data
• Prepare and/or review QC protocols and reports
• Prepare and review SOPs on test methods and other procedures relevant to QC.
• Prepare and review Deviation, CAPA and Change Control documents.
• Lead investigations on Deviations and OOS results.
Requirements
• Education in life science / biochemistry / pharmaceutical sciences or relevant experience.
• Strong biologics experience with the quality control department.
• Broad knowledge and experience in quality control, including stability study management.
• Broad knowledge of cGMPs and regulatory requirements for testing and stability pertaining to biotechnology and pharmaceutical industries.
• Broad knowledge and experience with a variety of analytical techniques including, but not limited to SDS PAGE, ELISA, HPLC.
• Experience in statistical evaluation of analytical results and stability study data.
Skills
• Excellent communication, interpersonal and training skills (German and English language).
• Excellent technical writing skills and experience in writing SOPs (German and English language).
• Proven ability to establish collaborative working relationships; team-oriented and must be able to work independently.
• Excellent ability to prioritize and manage multiple projects and tasks.
• Personal attributes include flexibility, integrity, action- and goal-oriented.