Raw Data Inspector
Vor 5 Tagen
Lonza is a global leader in life sciences operating across three continents. Our company's success depends on talented individuals who work together to devise innovative solutions. At Lonza, we empower our employees to own their careers, enabling them to genuinely make a meaningful difference.
As a Raw Data Inspector, you will be responsible for performing QA raw data review for Drug substances and drug products. This involves QC raw data review from QA and corresponding documentation preparation ensuring compliance to Lonza's standards and customer requirements.
Key Responsibilities:
- Control of QC raw data (drug product and Lonza GMP sales product)
- Planning and setting deadlines with QC
- Organization of meetings, if necessary
- Triggering and processing deviations
- Creating new checklists for raw data verification and updating existing ones
- Ensuring communication with responsible QA and QC employees
- Checking QC raw data (without release in LIMS)
- Release of LIMS calculations in DMS (Documentation Management System)
Required Skills and Qualifications:
- Bachelor's degree in chemistry, biotechnology, life science or related field
- 3-5 years of experience in the pharmaceutical industry, preferably in a QC or QA function
- Founded analytical expertise
- Strong background in cGMP regulations
- Solution-oriented and team-minded individual
- Ability to oversee project execution to identify non-compliance from procedures
- Excellent verbal and written communication in German and English
We prioritize ethical behavior and respect for our people and environment. At Lonza, you will have the opportunity to work on complex problems and develop new ideas in life sciences.
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