QC Professional II
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QC Professional II
The primary role of the QC Professional II in the QC Laboratory is to perform projects that contribute to the overall performance of the lab and to be a technical expert. The QC Professional II will try constantly to challenge and improve the existing way of working and to balance the status-quo (Lean, Blue Belt, Gemba walk, 5S, periodic qualification review, update of documents, …) and will also provide support to conduct appropriate investigations and troubleshooting of recurrent issues that occur in routine operations. The QC Professional II will also be responsible of the trending analysis and the update of the trending tool (example : NWA).
He will manage smooth collaboration with Regulatory peoples and third parties (for example : equipment suppliers) and will work strongly in collaboration with the QC Management team as well as with QC Laboratory Team Coordinators.
- Beat for laboratory continuous improvements (lean lab, levelling, 5S, Gemba walk, Blue Belt, TIER I implementation…)
- Investigate and reduce recurrent invalid, OOL, OOS, equipment failure, event to improve the Right First Time
- Support Regulatory questions linked to local QC responsibilities (examples : reagents and standard supply, English translation of testing SOPs…) in the context of submissions or inspections
- Manage smooth collaboration with third parties (example : equipment suppliers)
- Perform trending’s of results (IC, IPC, Release…) and maintain trending tools (NWA)
- Review and approve for Local QC GMP documents (example: PDTS protocol, Analytical Method validation report, equipment qualification file…)
- Guarantee the latest update of documents (example : DCR), trainings of analyst (example : periodic qualification review), critical biological reagents management, …
- To work in a team spirit with all other QC members
- Master or PhD in Biomedical Sciences or equivalent (a senior experience in a QC laboratory from Biopharma company is acceptable)
- Added value and result oriented
- Excellent communicator and team spirit
- Organized and efficient
- Knowledge of the Good Laboratory Practices
- Enthusiastic, positive spirit and open mind
- Fluency in writing scientific French and good knowledge of English (verbal/writing)
- Good working knowledge of MS Office programs
Schedule: Day shift
Reports to: QC Biology Supervisor / QC Laboratory Manager
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Job ID SR0044841