Project Lead Quality Control Puurs
Location: BelgiumSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical and Clinical Research organisation, based in Antwerpen Belgium.
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.
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.)
- 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)
Master (industry) pharmacist
bio-engineer chemistry / cell and gene biotechnology
industrial engineer chemistry / biochemistry
master analytical chemistry
master biochemistry
Experience:
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).
Knowledge of:
Project management
Method transfer / Method validation
Analytical chemical techniques: HPLC, UPLC, SEC, IC, GC, Karl Fisher, AAS, SDS, CE, IEF, Slot Blot, ICP-OES, ELISA, ....
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ewout de Jong.
The Company
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 Description
The 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.)
Responsibilities
As 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)
Requirements
Education: Science directionMaster (industry) pharmacist
bio-engineer chemistry / cell and gene biotechnology
industrial engineer chemistry / biochemistry
master analytical chemistry
master biochemistry
Experience:
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).
Knowledge of:
Project management
Method transfer / Method validation
Analytical chemical techniques: HPLC, UPLC, SEC, IC, GC, Karl Fisher, AAS, SDS, CE, IEF, Slot Blot, ICP-OES, ELISA, ....
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ewout de Jong.
Prosimy o aplikowanie poprzez przycisk znajdujący się po prawej stronie ogłoszenia.
