Quality Officer

Client

Our client is a leading Project Management and Engineering company serving the pharmaceutical industry around the world.

Bachelor degree (HLO) preferable in Biotechnology, Chemistry, or relevant field.
At least 2 years of relevant experience in the pharmaceutical industry.
Experience with quality and compliance guidelines and manufacturing processes.
Technical knowledge in manufacturing/packaging processes and testing techniques
Technical Writing, Root Cause Analysis, Failure Mode & Effect Analysis (FMEA), CAPA establishment and Lean Six Sigma.
Quality by Design, Process Analytical Technology, product Qualification/Validation.
Effective planning skills.
Statistical knowledge
Excellent interpersonal and communication skills, oral and written (Dutch and English).
Experience with documentation system and SAP preferable.

Serve as a quality advisor for investigators and recommends actions.
Provide guidance in product related GMP questions.
Reviews and approves cGMP documents associated to the product in compliance with site SOPs, Company Guidelines/ Procedures and federal as well as local agencies regulation supporting business goals.
Execute batch records review.
Review and approve logbooks and log sheets.
Review and approve cleaning and sterilization records.
Prepare documentation package for release for products manufactured.
Support and approve investigations and CAPA plans.
Manage, evaluates and approves changes assuring they are in compliance with applicable SOP’s.
Participate in Quality Area projects to develop and implement improved/lean processes.