You are a quality control laboratory specialist and you are looking for a new challenge ? We have your new opportunity. For one of our client based in Neuchâtel we are looking for a QC Project Coordinator, Lab Upgrade Project.
To support the execution of a major renovation project of the analytical Quality Control (QC) laboratories, we are seeking a Project Coordinator with a solid project management and GMP background to coordinate activities.
The project aims at renovating and expanding the analytical Quality Control (QC) laboratories within the existing facility to create additional testing capacity and support development of the site. The lab upgrade project will be executed in a phased approach to maintain testing capacities and QC operations throughout project execution and will require to move, install and (re)qualify laboratory equipment as construction and renovation progresses.
The QC Project Coordinator will report directly to the Head of QC. He/She will partner with the Engineering function leading the project to ensure full alignment of activities internal functions with the overall construction and commissioning schedule. The Coordinator will drive cross-functional evaluations of change controls, drive execution of action plans, lead GMP risk and impact assessments, coordinate creation, review/approval of qualification plans and protocols and their execution with internal functions and external QC vendors.
- Skills/Knowledge Required
- Relevant experience in project management, experience leading QC laboratory projects a plus.
- Experience leading GMP Change Controls and Risk Assessments
- Knowledge of GMP equipment qualification requirements
- Ability to work independently, lead and participate in a team
- Strong organizational skills and ability to effectively manage assignments
- Strategic thinking and team facilitation skills
- Advanced written and verbal communication skills
- Duties and Responsibilities
- Establish and maintain a detailed execution plan for activities under the responsibility internal functions, that is aligned with the construction and commissioning schedule.
- Establish and maintain transparency by supporting development, updates and maintenance of project status reports and associated dashboards.
- Act as a central point of contact for QC users and the Engineering and Construction team for daily questions and giving all needed input in terms of planning.
- Own Change Controls associated with the project, lead cross-functional evaluations and ensure on-time execution of action plans. Ensure Quality pre-requisites are met for each phase of project execution.
- Coordinate, moves, procurement, installation and (re)qualification of laboratory equipment with QC users, Validation and External Vendors
- Support with management of Deviations.
- Ensure that communications between teams, functional management, project leadership and sponsors are handled in an efficient, effective and timely fashion.
- Support GMP compliance and audit readiness of QC laboratories throughout the project.
- Definitions and Abbreviations
GMP: Good manufacturing practice
QC: Quality Control
- French/English (min B2)- site language/daily communication with internal stakeholders is in French. All technical GMP documentation is to be written in English, frequent communication with external companies/vendors in English