QA Analytics Specialist

QA Analytics Specialist

Lonza

Visp, Switzerland

The role:

The QA (Quality Assurance) Analytics Team is recruiting a dedicated person who wants to work as a Senior QA Specialist in analytics in a fast-growing and innovative environment. As a Senior QA Specialist for Analytics, you will be responsible for ensuring Quality oversight on GMP-relevant activities carried out by the Quality Control and Analytical Development (AD) departments.

This includes the review and approval of SOPs, analytical methods/specifications, and validation plans/reports assuring their compliance with Lonza’s standards, customer requirements, and health authority expectations. 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.

Key responsibilities:

• Representing the QA concerns to the Quality Control (QC) department and ensuring 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.

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.

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Switzerland      Biotechnology and Genetics      Pre-clinical Research and Development      Quality Assurance      Lonza