Quality Control Chemical Team Leader

작업 내용

To strengthen our Internal Manufacturing department, based in our hub in Braine-l’Alleud, Belgium, we are looking for a talented individual to fill the position of Quality Control Chemical Team Leader.

As Quality Control Chemical Team Leader, you like to work in an environment where you can:

• Manage the technician team of the QC NCE (New chemical entities) lab to ensure analyses of New Chemical Entities supporting release and stability.
• Support testing for New Chemical Entity projects from phase III through the life cycle of the product, sharing with the team his high-level scientific expertise and experience.
• Increase expertise in the lab by training technicians to analytical techniques and support troubleshooting for analytical QC NCE lab. The team leader will play a key role in the implementation of new technologies in QC NCE Lab and act as an expert with other parties.
• Coordinate all requests of analysis (electronic or paper) ask by the stakeholders, to ensure the follow-up and communicate the results.
• Prepare, verify and communicate the weekly planning of the technicians.
• Participate to all meetings with stakeholders in term of planning and samples follow-up.
• Support projects, deviations and investigations within the laboratory.

In a nutshell, as Quality Control Chemical Team Leader, you will:

HSE

• Apply the company’s Health and Safety policy within the laboratory.
• Ensure a safe working environment to meet site safety objectives.

Management

• Motivate, recognize team members performance, behaviors and compliance of rules whilst firmly supporting teamwork and spirit.
• Manage conflicts.
• Increase team’s competency by ensuring adequate training, coaching and development of technicians in function of the team and people potentials.
• Define and communicate openly the objectives of individuals and of the team in accordance with the company’s strategy and formally assess the results with the adequate KPI (Key Performance Indicators) covering HSE, quality and overall performance both for the individuals and the team.
• Ensure continuous feedback: technicians, peers, management, and stakeholders.
• Ensure job descriptions & training plan of people are in line with the QC organization.

Operations

• Ensure the day-to-day operational planning and coordination to satisfy the stakeholder/client needs based on a monthly forecast.
• Organize daily meetings with team (Tier 1) to follow-up on the planning and collect and give information. Ensure that each one contribution is done in due time.
• Ensure required corrective actions are taken and put in force.
• Implement, follow-up and communicate on KPI with its related corrective actions.
• Inform stakeholders and responsible of the lab if deviations from the day-to-day-planning occur.
• Be prepared and participate actively to weekly/monthly planning meetings, propose solutions, demonstrate creativity and pro-activity to ensure adherence to plan and performance.
• Ensure that continuous improvement is part of day-to-day activities of the laboratory.
• Ensure that the lab infrastructure including facilities, utilities and equipment are well maintained.
• Maximize the utilization of departments budget within given budget limits.
• Be accountable for a pro-active collaboration with different stakeholders.

Quality

• Ensure follow-up and compliance of procedures and instructions, and update if needed.
• Ensure follow-up of corrective actions and preventive actions.
• Ensure audit readiness, participate to the preparation, the follow-up and the realization of audits.
• Ensure the follow-up of OOS and take actions to reduce the number of laboratories OOS.
• Ensure adequate training/coaching of technicians linked to the analytical activities requested and performed.

Interested? For this position you’ll need the following education, experience and skills:

Education

• PhD or master’s degree required in chemistry or equivalent.

Experience

• Min 5-8 years of expertise in the pharmaceutical analysis.
• Expertise in HPLC/UPLC.
• Proven experience in GMP environment.
• Proven experience on the use of LIMS software for sample management is an asset.
• Proven experience on the use of Trackwise software for deviation management is an asset.
• Proven project leadership skills including planning, monitoring, issue resolution, investigations (DMAIC, 5M, etc), decision making and reporting.
• Green belt ownership is an asset.
• Understanding of all analytical disciplines related to CMC for late stage development and commercial products (analytical development, stability testing and quality control of drug substance, drug product, raw material and intermediate).
• Implementation and maintenance of 5S mind set and environment is an asset.
• “Green” mind set is a requirement.
• Fluent in English and French.