Job Description
The Scientist QC Raw Materials plays a key role in supporting drug product manufacturing by executing incoming goods Control Testing of Raw Materials. This involves managing specifications, testing, and release of raw materials used in clinical and commercial production.
Key Responsibilities:
1. Evaluates test results from external laboratories against specifications and historical data, reporting them into Lonza's electronic system.
2. Determines testing requirements for Raw Materials against compendial and internal standards for release.
3. Collaborates with external testing laboratories on laboratory investigations.
4. Develops and revises Specification Sheets and associated change management documentation.
5. Analyzes data for reports and presentations, drawing conclusions based on findings.
6. Authors and approves reports and standard operating procedures.
7. Contributes to process improvement initiatives to enhance efficiency.
Key Requirements:
1. A qualified technician with at least 5 years of pharmaceutical industry experience, preferably in raw materials or related science field, with 2-3 years of experience in the pharmaceutical industry.
2. Familiarity with cGMP concepts and practical experience working under GMP.
3. Hands-on experience with analytical testing methods and instruments for raw materials is highly beneficial.
4. Strong problem-solving and analytical skills.
5. Excellent verbal and written communication skills.
6. A proactive attitude and strong team working skills are essential.
7. Advantageous: Experience with Raman, NIR/FTIR Spectroscopy techniques.