The actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.
As a Senior Quality Assurance (QA) Specialist (f/m/d) for Analytics, you will ensure Quality oversight on GMP-relevant activities carried out by the Quality Control and Analytical Development (AD) departments, including 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). As a Quality and Compliance representative, you are a key member of cross-functional project teams.
Tasks
- Represent QA concerns to the Quality Control (QC) and Analytical Development (AD) departments and ensure GMP requirements are met and SOPs are followed
- Control and release GMP-relevant documents of the QC / AD
- Review and approve SOPs, analytical test methods, method transfer protocols/reports, method validation protocols/reports, and OOX gLIMS investigations issued by the QC/AD departments
- QA supervision of OOX events during investigation in QC/AD departments: 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
- Ensure compliance with GMP in the areas of stability testing and reference standards
- Cooperation, review and approval of deviations (DRs), Investigations (INVs), changes (CRs), and CAPAs within analytics (QC)
- Support inspection/audit
- Ensure compliance of Lonza QC test methods with Pharmacopoeias where applicable
Requirements
- Academic degree in Chemistry, Biotechnology, Life Sciences or related field
- Significant experience in the pharmaceutical industry; preferable 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 interaction with health authorities (FDA, Swissmedic, etc.)
- Excellent verbal and written communication in English
- German language knowledge is advantageous
Benefits
- An agile career and dynamic working culture
- An inclusive and ethical workplace
- Compensation programs that recognize high performance
- A variety of benefits dependent on role and location
Bist du Teil dieses Unternehmens?
Dieses Unternehmensprofil wurde automatisch erstellt. Wenn du für Lonza Group AG arbeitest, kannst du das Profil jetzt beanspruchen und verifizieren – kostenlos und in wenigen Minuten.