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Consultant Assurance Qualité
Eingestellt von Harvey Nash IT Recruitment Belgium
Gesuchte Skills: Consultant, Client
Projektbeschreibung
Our client is a PHARMACEUTICAL COMPANY and is looking for a QA CONSULTANT to be involved in QA ACTIVITIES related to one of their suppliers (CMO). The QUALITY ASSURANCE CONSULTANT will work at our client for at least 12 months.
The QA Consultant will:
Provide senior QUALITY SUPPORT to projects at the vendor (contract manufacturing organization)
Represent the QUALITY DEPARTMENT on project teams and sub-teams related to:
- MANUFACTURING PROCESS REVIEW and process improvement
- ANALYTICAL METHOD REVIEW and redevelopment of analytical methods
- Process and method transfers between manufacturing sites and analytical laboratories
- Quality risk mitigation activities
- Regulatory submissions as above
Provide senior Quality expertise in the review and approval of project related technical, analytical, and quality documents
Be responsible for oversight and tracking of project and quality related activities (project management).
Drive the quality related project activities in accordance with overall project plan.
Escalate any delays or constraints to the project leader
The Quality Assurance Consultant is/has:
- Minimum of 7-10 years working in the pharmaceutical/biologics industry with a profound knowledge and understanding of Quality management and operational GMP experience
-Experience and knowledge about European Good Manufacturing Practices
- Good pharmaceutical technical understanding and expertise enabling to review and judge upon technical documents related to manufacturing and analytical testing
- Project management expertise: Sets deadlines, assigns responsibilities, and monitors and summarises progress of project. Responsible for maintaining schedules and estimates to ensure deadlines are set and met accordingly for assigned projects. Prepares reports for upper management regarding status of project. Familiar with a variety of the fields concepts, practices, and procedures. Relies on extensive experience in this field and judgment to plan and accomplish goals.
Keywords: ASSURANCE QUALITÉ, AQ, GMP, BPF, CMO, CONTRACT MANUFACTURING ORGANIZATION, ASSURANCE QUALITÉ, AQ, GMP, BPF
The QA Consultant will:
Provide senior QUALITY SUPPORT to projects at the vendor (contract manufacturing organization)
Represent the QUALITY DEPARTMENT on project teams and sub-teams related to:
- MANUFACTURING PROCESS REVIEW and process improvement
- ANALYTICAL METHOD REVIEW and redevelopment of analytical methods
- Process and method transfers between manufacturing sites and analytical laboratories
- Quality risk mitigation activities
- Regulatory submissions as above
Provide senior Quality expertise in the review and approval of project related technical, analytical, and quality documents
Be responsible for oversight and tracking of project and quality related activities (project management).
Drive the quality related project activities in accordance with overall project plan.
Escalate any delays or constraints to the project leader
The Quality Assurance Consultant is/has:
- Minimum of 7-10 years working in the pharmaceutical/biologics industry with a profound knowledge and understanding of Quality management and operational GMP experience
-Experience and knowledge about European Good Manufacturing Practices
- Good pharmaceutical technical understanding and expertise enabling to review and judge upon technical documents related to manufacturing and analytical testing
- Project management expertise: Sets deadlines, assigns responsibilities, and monitors and summarises progress of project. Responsible for maintaining schedules and estimates to ensure deadlines are set and met accordingly for assigned projects. Prepares reports for upper management regarding status of project. Familiar with a variety of the fields concepts, practices, and procedures. Relies on extensive experience in this field and judgment to plan and accomplish goals.
Keywords: ASSURANCE QUALITÉ, AQ, GMP, BPF, CMO, CONTRACT MANUFACTURING ORGANIZATION, ASSURANCE QUALITÉ, AQ, GMP, BPF
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Organisation/Management