Sterility Assurance & Aseptic Processes Expert – France

ProductLife Group; France; On-site; EUR 60,000 - 100,000; Full time

Job summary

A consulting firm specializing in life sciences is seeking a Sterility Assurance and Aseptic Processes Expert in France. The role involves leading sterility assurance strategies, performing risk analyses, drafting scientific documents, and supporting regulatory inspections. Candidates should have 5-7 years of relevant experience (or 10+ for experts) and be fluent in French and English.

Qualifications

• 5-7 years of experience for confirmed or 10+ years for expert level.
• Experience in sterile operations and risk management.
• Fluency in French and English.

Responsibilities

• Lead sterility assurance strategy and implementation.
• Conduct risk analyses and execute CAPA follow-up.
• Support for regulatory inspections and documentation.

Skills

GMP Annex 1

Aseptic filling under isolator

Risk management

Regulatory knowledge (EMA, FDA)

Job description

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