QA Raw Material Compliance Specialist

Location Netherlands
Discipline: Biotechnology, Pharmaceutical
Job type: Temporary/Freelance
Contact name: Merel van Os

Contact email: m.vanos@panda-int.com
Job ref: 12354
Published: 14 days ago

The Raw Materials Compliance Specialist interacts directly with Lonza’s internal and external customers for disposition of materials, resolution of release issues and other material related work as needed. As an established Subject Matter Expert (SME) in the material receipt, testing and disposition process, they will be expected resolve complex issues, triage issues for escalation to area management and train junior staff members.

 

They will provide resolution to escalated issues within their area of responsibility and will help define the strategy for remediation of escalations/issues and improvements efforts. The Specialist will also be expected to perform all associated SAP transactions as part of the release as well as other Quality functions within SAP.

 

They will require little direction and coaching for day to day activities, are expected to be subject matter experts to the associated workflows and able to manage the escalation of issues.

 

  •  Review, manager and ensure compliance with GMP regulations for raw materials pertaining to commercial manufacturing

 

  • Serves as the SME for internal and external customers on technical transfers

 

  • Works with project teams to on-board raw materials

 

  • Update and revise SOPs as required to ensure compliance

 

  • Keeps up to date with compliance and regulation guidelines within the industry

 

  • Understands and makes informed decisions pertaining to testing and testing selections for materials

 

  • Supporting the site as final QA on all change control from the areas of MSAT, PW&L

 

  • Attend meetings prepared to speak to the project/change and identify Quality requirements

 

  • Consult with quality management on decisions to ensure alignment and agreement

 

  • Perform other duties as assigned