Job Description

For one of our clients in the pharma industry we are looking for a freelance Quality Control (QC) / Analytical MSAT Specialist for drug-product manufacturing and packaging

Project Name: Analytical Method Transfer Consultancy – Animal Vaccines

Project Description: The project encompasses the analytical transfer accompanying a strategic Animal Vaccine drug-product manufacturing and packaging transfer initiative. The objective of this assignment is the independent technical execution of analytical method transfer documentation, the structuring of technical packages, and the evaluation of compliance parameters. The goal of the project is to have documented analytical method transfers.

Tasks:

Preparation of technical transfer packages

• Creating the ultimate "moving manual" so the new factory knows exactly how to do the work.
• Creation of step-by-step instructions on how to test the animal vaccines (checking them for viruses, bacteria, and chemical makeup) so the new factory knows exactly how to approve the final product.
• Capturing of expert knowledge:
• Interviewing the scientists and experts at the original factory to capture all their "insider knowledge" and undocumented tricks.
• Creation of a moving checklist:
• Creation of the core transfer documents. This includes identifying exactly what equipment is needed, how to test samples, figuring out what might be missing (gap analysis), and writing the plan to gauge if the new location can do it right (validation).
• Organizing the files: Gathering all standard operating procedures (SOPs) and manuals, translating files that are not already translated, and organizing them into one clean, usable master folder.

Execution of transfer compliance assessments

• Review that the new location follows all strict pharmaceutical laws, quality standards, and internal rules.
• Communication to all the different departments (like Quality Control, Engineering, and Supply Chain) to see if newly transferred testing methods meet everyone's specific rules and legal requirements.
• Writing progress reports: These reports explain what has been finished, flag any potential risks or roadblocks, and record any major technical decisions that were made to keep the project moving.
• Proofreading for quality: Double-checking all the project documents to review they are accurate, easy to understand, and follow Good Manufacturing Practices (GMP—the strict quality laws of the pharmaceutical industry).

Key Deliverables:

• Creation of comprehensive documentation with all results regarding the above-mentioned tasks with subsequent handover to Boehringer Ingelheim for review and approval for further usage

Required skills, qualifications and experience:

• 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.
• Bachelor’s or Master’s degree in pharmaceutical sciences, biotechnology, biology, chemistry, chemical/process engineering, mechanical engineering or a comparable discipline; a doctorate is advantageous but not required.

Start: ASAP

Duration: till 30.06.2027

Capacity: 40 hours/week

Location: 75 onsite (Lyon, France), 25% remote