Key Activities Create material specifications as part of the material qualification activities to support material releases.
Ensure material is sourced/implemented with the required quality grades for clinical manufacturing.
Collaborate with internal and external stakeholders (tech transfer, procurement, manufacturing) for material identification and supplier selection. Contribute to define a standardized material platform.
Support supply chain team (and build technical competence) on quality and compliance related issues through investigations, change controls, quality risk assessments etc.
Assess all material related changes (vendor or site initiated) and drive quality change control where needed.
Acts as point of contact for supply chain quality and compliance issues (Deviation management). Lead the more complicated quality investigations (or significant investigations) and coach the team. Develop teams technical writing competency. Facilitated in problem solving and RCAs for technical and complex issues.
Create and change policies and procedures in the supply chain space in alignment with regulatory requirements. Evaluate consequences/impact for changing internal and external guidelines.
Seek and lead improvement projects to improve our Team’s compliance posture for site and supply chain initiatives
Initiate and formulate proposals / business cases for quality improvement projects including deliverables and planning for the development and implementation of proposed improvements. Lead overall team strategy actions and continuous improvement projects.
Requirements Bachelor’s or Master’s degree in engineering, pharmacy or science related field or a minimum of 3 years’ experience working in a relevant academic or industry field.
Experience within quality operations/ compliance or supporting supply chain or operations role within a pharmaceutical company
Excellent command of English, both written and verbal – ability to work within all levels of the organization from shopfloor staff to site leadership team.
Experience in leading change management initiatives – building both people competence and introducing new processes
Computer literate with advanced skills in MS Office, especially Excel
SAP knowledge is an advantage
This is a temporary position, more information will be provided upon application
#J-18808-Ljbffr