QA operational

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