PRIMARY PURPOSE OF POSITION
MAJOR DUTIES OF POSITION
- Perform and supervise quality control laboratory activities in the material management group including raw material testing, qualification of reference materials and critical reagents as well as testing of water quality for production
- Review test raw data and ensure accuracy and compliance
- Prepare and review protocols and reports related to the above mentioned activities.
- Supervise raw material testing and release and ensure availability of raw materials for production.
- Supervise qualification of reference standards and critical reagents and ensure availability of reference standards and critical reagents for QC Analytics.
- Manage analytical work subcontracted to contract laboratories, review reports and ensure timely completion
- Provide technical guidance in resolving issues as well as making process- and method improvements.
- 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
- Represent QC in various internal and external meetings
KNOWLEDGE AND SKILL REQUIREMENTS
- BS in life science / biochemistry
- Several years biologics quality control working experience
- Broad knowledge and experience in quality control, including analytical chemistry
- Broad knowledge of cGMPs and regulatory requirements for raw material testing pertaining to biotechnology and pharmaceutical industries, including knowledge on relevant compendial methods
- Laboratory experience with a variety of analytical techniques such as several pharmaceutical raw material identity test methods, TOC testing, Endotoxine testing and FT-IR
- 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
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