Quality Management Specialist

Red Commerce Schweiz GmbH

Western Europe, Switzerland

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29/08/2024

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Quality Management Specialist

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RED is seeking a Quality Manager for one of our clients based in Zurich. This is a 18 months assignment - contractor role

Key Responsibilities:

Develop and manage the lifecycle strategy for analytical methods in product testing.
Coordinate multisite assay transfers, collaborating with internal and external laboratories.
Serve as the expert for biological, molecular, and microbiological analytical methods.
Quickly resolve analytical issues to ensure product quality and compliance.
Provide technical support for troubleshooting laboratory challenges.
Apply statistical and chemometric techniques to solve complex analytical problems.
Represent Quality Control on technical teams and collaborate with subject matter experts.
Create and approve validation protocols, reports, and standard operating procedures (SOPs).
Oversee the re-manufacturing of critical reagents for analytical methods.
Ensure all methods comply with GMP, Pharmacopeias, and industry standards.
Build and maintain strong relationships with laboratories and internal teams.
Lead cross-functional meetings with laboratories and experts.

Requirements:

Degree in microbiology, pharmaceutical science, biotechnology, chemistry, or a related field with at least 3 years in QC or QA.
Strong knowledge of pharmaceutical Quality Management Systems and QC processes.
Experience in outsourced manufacturing/testing, especially with vaccines and biologics.
Familiarity with cGMPs (US and EU) and CMC regulatory requirements.
Expertise in microbiological methods, instrumentation, and data analysis.
Proven track record in leading Technology Transfers with CMOs and internal teams.
Excellent communication skills, capable of explaining technical issues to non-technical audiences.
Strong team player with effective collaboration skills.
Proficient in English; German is a plus.
Six Sigma Lean Laboratory, Greenbelt, or Blackbelt Certification preferred.

If you meet these qualifications and are interested in this opportunity, please share your updated CV with mmartins@redglobal.com.

Reference

CR/120543_1724843232