For our biopharmaceutical partner, Gi Life Sciences is looking for a :
QA Project Manager
(Temporary Contract – 6 months)
Your responsibilities:
Support continuous improvement programs to establish an effective Quality Management System
Represent Quality Assurance in cross-functional teams, establish and maintain close collaboration with different department
Assess, review and approve quality records : deviations, change control, CAPAs, investigations, effectiveness checks, extensions in line with current local SOPs
Author, review and approve GMP-relevant documents and SOPs
Responsible to present Drug Product QA topics during the conduction of all customer audits and regulatory inspections within DP
Participate in internal audits as required by the organization
QMS : Organize and manage monthly Quality Council & Risk Register
KPI reporting Tracking of key Quality indicator in QA staff meeting
Support and approve project / product specific risk assessments
Review and release product specific documentation such as process descriptions and workflows, recipes, manufacturing protocols, transfer documents, test plans, parameter lists, etc
Review and approve executive batch records, prepare batch release for the responsible person (FvP), including recommendation on disposition status
Customer contact in regards to QA topics. Support and manage interactions in cases of changes, deviations, technical complaints, out of specification results and others
Delegate of FvP for Batch Disposition of DP
Your profile:
Languages : English. German an asset
Similar experience in GMP industry
Your contact at Gi Group : Anaïs Mieszczak
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