The companyOur client is a professional Pharmaceutical and Clinical Research organisation, based in Anvers Belgium. In the production departments in Puurs, raw materials with active ingredients are formulated aseptically and aseptically filled with injectable drugs.
The Quality Control (QC) department is responsible for testing the production processes, testing process intermediaries, and after filling quality control of finished products and stability studies.
Worldwide, colleagues work together to achieve a positive impact on everyone's health everywhere. Every position with our client contributes to the success of our company and global health. That is why our client, as the world leader in the biopharmaceutical industry, is looking for new talents to inspire us and to let us know what the values and message of the world are to make a healthier place.
Role descriptionThe function of PROJECT LEAD is situated within the chemical lab under this QC department. This lab is an analytical and bioanalytical method such as HPLC, UPLC, SEC, IC, GC, Karl Fisher, AAS, SDS, CE, IEF, Slot Blot, ICP-OES, ELISA, ....
You work in the project organization of this department, which is responsible for the coordination and development of QC deliverables within site critical projects (eg Method transfer for temporary production of clinical products, QC readiness for launching new pipeline products in Puurs, the transfer of new commercial vaccines, design of lab infrastructure, etc.)
ResponsibilitiesAs QUALITY CONTROL OF PROJECT MANAGERS, you have the following responsibilities:
- You are ready for quality and timely completion of the QC deliverable
- Managing and coaching your project team (2-5 project engineers as direct reports)
- Preparation, management and maintenance of the project planning
- Briefs and debriefs from your stakeholders (the team of analysts and their supervisor, Program leader, analytical sub-team, Drug Product -Team, QC of other sites, QA, ..)
- You participate in risk analyzes for the project and a macro mitigation plan
- Resource calculation for the project (both analysts and project engineers)
- You negotiate with the analyst team supervisor for timely analysis of analysts and planning of tests
- You manage a DMS meeting that covers the daily follow-up of tests within the lab, in the name of the applicant and lab coordinator / supervisor, and visualises the project work on the work floor.
- Initial investment of budget for lab equipment (CPA) + follow-up of expenses
- Organization of project team meetings, To follow up the activities that have to be carried out within QC, I am the project
- You facilitate problem solving and monitor the quality of the research and CAPAs (DMAIC)
- You are ultimately responsible for extreme documentation (VPP / VPR, TA, AMTP / R, AMVP / R, ..)
- You help think of process improvements in cooperation with the system owners (continuous improvement)
RequirementsEducation: Science direction
Master (industry) pharmacist
bio-engineer chemistry / cell and gene biotechnology
industrial engineer chemistry / biochemistry
master analytical chemistry
You have +/- 5 years experience with QC processes, with focus on method transfer and validation.
You have proven track record of project management skills (project planning, stakeholder management, resource estimation).
Method transfer / Method validation
Analytical chemical techniques: HPLC, UPLC, SEC, IC, GC, Karl Fisher, AAS, SDS, CE, IEF, Slot Blot, ICP-OES, ELISA, ....