For our customer located in Zurich/Switzerland we are currently looking for a: Quality Manager (m/f/d)
- Location: CH-Zurich (Opfikon-Glattpark)
- Branch: Pharma
- Duration: 08.05.2023-31.03.2024
Tasks & 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
- Degree in microbiology, pharmaceutical science, biotechnology, chemistry or closely related field with a a minimum of 3 years experience within a QC laboratory or QA organization (with oversight of QC activities)
- A thorough understanding of pharmaceutical QM Systems 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
- Fluent English is required
- University Masters degree or higher
Nice to Haves
- Six Sigma Lean Laboratory or Greenbelt Certification preferred
- German beneficial (spoken and written)
Did we catch your interest?
The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).
Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.