QC & Analytical MSAT Specialist - Remote/Hybrid (Lyon)

Kommlink GmbH; Lyon; Hybrid; EUR 60,000 - 90,000; Part time

Job summary

Kommlink GmbH in Lyon, France is seeking a freelance Quality Control (QC) / Analytical MSAT Specialist for drug-product manufacturing and packaging. The role focuses on analytical method transfer documentation, transferring expert knowledge, and organizing compliance-ready technical packages.

You will drive transfer packages, SOP consolidation, and GMP-compliant documentation across the project team. Start ASAP; duration until 30.06.2027; 40 hours/week with 75 onsite and 25% remote work.

Qualifications

• 5–10 years of relevant professional experience in QC, MSAT, validation, Analytical transfer
• Experience in Analytical Method validation, transfers and technical/GMP document writing
• Experience leading teams or workstreams in a matrix organization
• Professional and convincing communication with internal and external international stakeholders
• Ability to work independently, autonomously and collaboratively in a project team
• Strong knowledge of compendial and non-compendial analytical methods covering Virology, Bacteriology and physiochemistry
• Knowledge of the pharmaceutical product lifecycle and the interfaces between Analytics, development, technical transfer, validation, regulatory submission and commercial supply
• Ability to evaluate analytical data, equipment and facility fit, method robustness, deviations, OOS, CAPAs and method validation or verification
• Knowledge of transfer-document preparation
• Language requirements: French and English

Responsibilities

• Prepare technical transfer packages and create a comprehensive moving manual for the new factory
• Create step-by-step test procedures for vaccine testing and product approval
• Capture expert knowledge from original factory staff and document insider tricks
• Develop transfer documents and core transfer plans, including equipment needs and gap analysis
• Organize and translate SOPs and manuals into a master folder
• Perform transfer compliance assessments and ensure GMP compliance
• Coordinate with Quality Control, Engineering and Supply Chain to validate testing methods
• Draft progress reports detailing completed work, risks, and key decisions
• Proofread project documents to ensure GMP compliance and clarity
• Create and deliver comprehensive documentation for Boehringer Ingelheim review

Skills

QC

MSAT

Validation

Analytical transfers

GMP documentation

Team leadership

Communication

Independent worker

Data evaluation

Transfer documentation

Education

Pharmaceutical sciences degree

Biotechnology degree

Chemistry degree

Process engineering degree

Mechanical engineering degree

Job description

Kommlink GmbH in Lyon, France is seeking a freelance Quality Control (QC) / Analytical MSAT Specialist for drug-product manufacturing and packaging. The role focuses on analytical method transfer documentation, transferring expert knowledge, and organizing compliance-ready technical packages.

You will drive transfer packages, SOP consolidation, and GMP-compliant documentation across the project team. Start ASAP; duration until 30.06.2027; 40 hours/week with 75 onsite and 25% remote work.