Senior QA Specialist, QA Analytics

Senior QA Specialist, QA Analytics

Lonza

Visp, Switzerland

As a Senior Quality Assurance (QA) Specialist for Analytics, you will ensure the Quality oversight on GMP-relevant activities carried out by the Quality Control and Analytical Development (AD) departments, also for externally formulated drugs (external DP final samples). This includes the review and approval of SOPs, analytical methods/specifications and validation plans/reports assuring their compliance to Lonza’s standards, customer’s requirements and health authority expectations (Pharmacopoeias). Moreover, as a Quality and Compliance representative, you are a key member of cross-functional project teams, e.g. for process transfers and new product introductions.

What you’ll do:

• Represents the QA concerns to the Quality Control (QC) and Analytical Development (AD) departments and ensures that GMP requirements are met and SOPs are followed;
• Control and release of GMP-relevant documents of the QC/AD;
• Review and approval of SOPs, analytical test methods, method transfer protocols/reports and method validation protocols/reports, and 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 your area of expertise and be the owner of these documents;
• Ensures compliance with GMP 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);
• Support inspection/audit;
• Ensure compliance of Lonza QC test methods with Pharmacopoeias where applicable;
• Performs QA raw data review and DP release where applicable.

What we’re looking for:

• Academic degree in Chemistry/Biotechnology/Life Sciences 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.