Senior Quality Assurance Specialist in Analytics
vor 3 Wochen
Quality Assurance Specialist for Analytics Role
The QA Analytics Team at Lonza is seeking a dedicated individual to join their team as a Senior Quality Assurance Specialist in Analytics. This role 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.
As a Quality and Compliance representative, you will be a key member of cross-functional project teams, including process transfers and new product introductions.
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 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.
Key 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.
We value our employees and the impact they make on our customers and the world. If you're passionate about quality and compliance, we encourage you to apply for this exciting opportunity to join our team at Lonza.
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