Overview
Sterility Assurance and Aseptic Processes Expert Jobs in France at ProductLife Group
Title: Sterility Assurance and Aseptic Processes Expert
Company: ProductLife Group
Location: France
About PLG
PLG is a consulting firm specializing in life sciences. We support our clients in their regulatory, quality, and industrial projects, providing them with expertise, agility, and commitment.
We are looking for: Sterility Assurance & Aseptic Processes Expert (Injectables)
Role / Mission
- Lead sterility assurance strategy and CCS/APS implementation.
- Risk analyses (initiation, execution, CAPA follow-up).
- Drafting of scientific justifications, protocols, reports, SOPs.
- Gap analysis vs. GMP Annex 1 & 13.
- Support for regulatory inspections and CCS documentation.
Experience level: Confirmed (5–7 years) or Expert (10+ years).
Technical Skills
- GMP Annex 1, sterile operations, aseptic filling under isolator.
- Risk management (AMDEC, deviation, change control).
- Strong regulatory knowledge (EMA, FDA).
Soft skills: Rigorous, organized, autonomous, analytical, strong relationship skills.
Practical Aspects
- Mobility across France is ideal; flexibility is possible in large industrial hubs.
- Languages: French and English are mandatory.
