Main duties & responsibilities:

The purpose of this role is to manage deviations occurring in our clients' various manufacturing units (USP and DSP), for the different products within quality system (i.e. Trackwise) in a timely manner:

• Perform evaluations related to impact on concerned equipment/product/material with the support of relevant experts.
• Perform root cause investigations using Six Sigma methodologies, including ability to collect and analyze data in the different automated systems and on-the-floor (regular GEMBA).
• Identify and implement relevant corrective and preventive actions (CAPA), including business case and planning preparation with relevant stakeholders.
• Write investigation and impact assessment reports in a comprehensive and scientific format
• Present report-out and/or escalate blocking points to line Manager
• Monitor and control internal deviations and CAPA KPI in concertation with line Manager
• Depending on deviation complexity, lead cross-functional investigation team including workshop or brainstorming sessions

Required skills :

• Bachelor/Master in Engineering field (chemical, biotechnology) or equivalent experience
• 3-5 years of experience within a biotech/pharmaceutical GMP manufacturing environment (manufacturing, quality or support functions
• Strong knowledge and interest in biotechnological processes (USP and/or DSP)
• Good knowledge of cGMP and associated regulations
• USP background would be a plus instead of DSP (it is nice to have, not a must).
• Fluency French and excellent command of English (fluency is an asset).

Thank you for your interest in this opportunity. Please note that only candidates selected for a first exchange will be contacted.