Quality Manager

vor 2 Wochen

Zürich, Zürich, Schweiz Experis Vollzeit

Quality Manager

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 inhouse analytical / technical expert for troubleshooting and investigating laboratory issues
  • Author / Review / Approve method validation/transfer protocols/reports and related SOP
  • Coordinate and lead remanufacturing and qualification of critical reagents for analytical methods
  • Author / Review / Approve quality control plans / qualification protocols/reports and retest 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.
  • Ability to work crossfunctional, 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
.


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

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