Senior Quality Assurance Expert for Analytics
vor 7 Stunden
Overview:
Lonza, a global leader in life sciences, is seeking a highly skilled Senior Quality Assurance Expert for Analytics to join our QA (Quality Assurance) Analytics Team. This role involves ensuring quality oversight on GMP-relevant activities carried out by the Quality Control and Analytical Development departments.
Responsibilities:
- Representing QA concerns to the Quality Control department and ensuring compliance with cGMP requirements and SOPs.
- Control and release of GMP relevant documents, including SOPs, analytical test methods, method transfer protocols/reports, and method validation protocols/reports.
- QA supervision for OOX events during investigation in QC/AD: Review and approve Out-of-Specifications/-Expectations/-Trend results.
- Writing or revising 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.
Compensation:
The estimated salary for this position is $120,000 - $180,000 per year, depending on qualifications and experience.
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