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Senior Quality Assurance Specialist for Analytics
vor 1 Monat
Quality Assurance Role Overview
The QA Analytics Team at Lonza is seeking a dedicated Senior Quality Assurance Specialist for Analytics to join our fast-growing and innovative environment. As a key member of our team, you will be responsible for ensuring Quality oversight on GMP-relevant activities carried out by the Quality Control and Analytical Development departments.
This includes reviewing and approving SOPs, analytical methods/specifications, and validation plans/reports to ensure compliance with Lonza's standards, customer requirements, and health authority expectations.
Key Responsibilities:
- Representing QA concerns to the Quality Control department and ensuring cGMP requirements and SOPs are followed.
- Control and release of GMP relevant documents, including SOPs, analytical test methods, method transfer protocols/reports, and method validation protocols/reports.
- QA supervision for OOXs events during investigation in QC/AD, reviewing and approving 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, including 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.
