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Quality Manager
Real StaffingZürich, SwitzerlandPiù di 30 giorni fa
Descrizione dell’offerta di lavoroDegree in microbiology, pharmaceutical science, biotechnology, chemistry or closely related field with a minimum of 5 years experience within a QC laboratory or QA organization (with oversight of QC activities). A thorough understanding of pharmaceutical QM Systems and respective guidelines and QC laboratory processes is required and experience in an outsourced manufacturing and testing environment is preferred. Experience in vaccines and biologics manufacturing and testing and related guideline and knowledge of pharmaceutical cGMPs (US and EU) and CMC regulatory requirements, preferred. Strong technical expertise in microbiology and microbial methods and instrumentation, and statistical methods for data analyses. Experienced at leading and delivering successful Technology Transfer activities across the CMO and internal network. English is required, German beneficial Six Sigma Lean Laboratory, Greenbelt or Blackbelt Certification preferred EU-Citizenship or valid Swiss Work Permit
Quality Manager
Location : Zürich, Switzerland
Duration : 18 months initial
Workload : 100% fulltime
Tasks :
- Drive and support analytical method life cycle management (LCM) strategy for in-process, release and stability testing of commercial products
- Leads multisite assay transfers via providing assay transfer strategy and project management with internal and external laboratories
- Serve as SME for analytical methods incl biological, molecularbiological and microbiological methods established in the commercial release testing laboratories
- Take ownership of analytical issues and drive closure quickly, correctly, and permanently for commercial products.
- Serve as in-house analytical / technical expert for troubleshooting and investigating laboratory issues
- Apply statistical analysis for data interpretation and apply chemometric principles to resolve complex analytical issues and applications
- Represent Quality Control on technical product teams
- Collaborate closely with in-house analytical / process technical expert for troubleshooting and investigating laboratory and manufacturing issues
- Author, review, and approve method validation / transfer protocols / reports, related SOPs, quality control plans, qualification protocols / reports, re-test protocols / reports of critical reagents for analytical methods, and regulatory relevant documents related to analytical methods.
- Coordinate and lead re-manufacturing of critical reagents for analytical methods
- Responsible for technical assessment of methods and changes to methods for compliance to GMP requirements, global Pharmacopeias, industry standards etc.
- Create and enhance collaborative and trusting relationships with internal and external laboratories and internal SMEs and establish effective communication
- Organize and lead cross functional team meetings with internal and external laboratories and SMEs
Requirements :
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.