Quality Oversight Specialist
Vor 5 Tagen
Job Summary:
The QA Analytics Team at Lonza is seeking a dedicated Senior Quality Assurance Specialist to ensure Quality oversight on GMP-relevant activities carried out by the Quality Control and Analytical Development departments.
Key Responsibilities:
- Represent the QA concerns to the Quality Control department and ensure that cGMP requirements and SOPs are followed.
- Control and release of GMP relevant documents of the QC Review and approval of SOPs, analytical test methods, method transfer protocols/reports and method validation protocols/reports, OOX iLab investigation issued by the QC/AD departments.
- QA supervision for OOXs events during investigation in QC/AD: Review and approve Out-of-Specifications/-Expectations/-Trend results.
- Write or revise SOPs in the area of expertise and ownership of these documents.
- Ensuring compliance with cGMP in the areas of stability testing and reference standards.
- Cooperation, review, and approval of deviations (DRs), Investigations (INV), changes (CRs), and CAPAs within analytics (QC).
- Participating in customer Audits and Inspections.
Requirements:
- Bachelor's or master's degree in chemistry, biotechnology, life science, or related field.
- Significant experience in the pharmaceutical industry; preferably in a QC or QA function.
- Founded analytical expertise and experience with analytical method validation
- Strong background in cGMP regulations; incl. USP, European and Japanese Pharmacopoeia.
- Auditing experience and experience in the interaction with health authorities (FDA, Swissmedic, etc.).
- Excellent verbal and written communication in English. German language knowledge is advantageous.
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