Quality Manager
Quality Manager
Candidates from EU who would like to relocate to Switzerland are welcomed
Experis IT is on the search for a Quality Manager to join one of their clients, a well-known pharma company based in Switzerland. This exciting temporary opportunity is only open to candidates with relevant experience. If you're looking to take your career to the next level, please read on!
Contact: Francesca De Chirico
Start Date: ASAP
Duration: 2 years - with further chance of extension
Location: Zürich
Workload percentage: 100%
Key Responsibilities:
- 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
- Drive and support analytical method life cycle management (LCM) strategy
- 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, molecular biological 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
- Author / Review / Approve method validation/transfer protocols/reports and related SOP
- Coordinate and lead re-manufacturing and qualification of critical reagents for analytical methods
- Author / Review / Approve quality control plans / qualification protocols/reports and re-test protocols/reports of critical reagents for analytical methods
Your Skills:
- Degree in microbiology, pharmaceutical science, biotechnology, chemistry, or closely related field with a minimum of 3 years experience within a QC laboratory or QA organization (with oversight of QC activities)
- A thorough understanding of pharmaceutical QMSystems and respective guidelines (ICH Q2) 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 is a plus.
- Strong verbal & written communication skills (including presentation skills). Can effectively articulate complex technical issues to non-technical audience. Proven ability to clearly articulate technical issues concisely and deliver effective presentations on complex technical subjects
- Ability to work cross-functional, independently but also in a teams
- English is required, German beneficial (spoken and written)
- Six Sigma Lean Laboratory or Greenbelt Certification preferred
Don't hesitate and send us your CV and testimonials today through the link in the advert.
Interested in this opportunity? Kindly send us your CV today through the link in the advert. However, should you have any questions please contact Francesca De Chirico on +41 (0) 44 2299925.
Even though this position may not be the perfect fit for you, please reach out to us, as we have hundreds of open positions at Experis IT across Switzerland.
Linkedin: Francesca De Chirico