For our partner in biotechnology industry, Gi Life Science is looking for:

QA operational

(temporary position)

Your mission:

• Support operational readiness of new product introduction

Your responsibilities:

• Responsible for the daily support of the manufacturing area (USP and DSP), including compliance, KPI,
• Schedule daily operational activities e.g. material staging, equipment daily checks
• Support equipment qualification activities
• Participation in the manufacturing of Upstream or Downstream manufacturing process operations
• Involved in change management including authoring change controls
• Involved in deviation management (deviations & CAPAs)
• Lead root cause analysis investigations
• Authoring Standard Operating Procedures (SOP’s) and Work Instructions (WIs)
• Actively involved in process FMEAs and Risk Analysis meetings
• Ensure required safety documents are in place for the operation of key process equipment
• Involved in creation of training curricula and hands-on training of other team members

Your profile:

• University degree in Pharmacy, chemistry or any relevant field
• Experience in a similar position in a GMP environment
• Fluent in English, French and/or german a plus
• Shift work may be required