Manufacturing Process Investigation Expert - Lausanne, Schweiz - Agap2 - HIQ Consulting AG

Beschreibung

Main duties & responsibilities:
The objective of this role is to manage deviations occurring in the various manufacturing units (USP and DSP) of one of our clients, for the different products within the quality system (i.e., Trackwise):

• Conduct evaluations regarding the impact on the relevant equipment, products, or materials with the support of relevant experts.
• Conduct deep-rooted investigations using Six Sigma methodologies (DMAIC, Ishikawa diagram, 5M, contradiction matrix, etc.), including the ability to collect and analyze data in various automated systems and on the field (regular GEMBA).
• Identify and implement relevant corrective and preventive actions (CAPA), including preparing a business case and plan with relevant stakeholders.
• Draft investigation and impact assessment reports in a comprehensive and scientific format.
• Depending on the complexity of the discrepancy, lead a cross-functional investigation team including workshops or brainstorming sessions.

Required skills :

• Bachelor/Master in Engineering field (chemical, biotechnology) or equivalent experience
• 1-3 years of experience within a biotech/pharmaceutical GMP manufacturing environment (manufacturing, quality or support functions)
• 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.