Quality Control Physico-chemical Team Leader
il y a 1 semaine
Make your mark for patients
We are looking for a
Quality Control Chemical Team Leader to join us in our Braine Technical Operations Team, Quality Control Department, based in our
Braine l'Alleud offices in Belgium
About the role
Scope:
- Release, Stability, project support analytical testing and double check for QC NCE related activities.
- Physicalchemical analytical activities supporting New Chemical Entities (NCE).
Nature:
- Managing the technician team encompassing NCE projects.
- being the QC representative for all chemical products.
- building strong analytical knowledge for Phase III and commercial chemical products.
- participating to the implementation and follow-up of new lab process flows.
- the management of regulatory aspect linked to activities, ensure the interface between the NCE lab and Regulatory Affairs, and ensure NCE testing lab being compliant to regulation requirement updates.
What you'll do
MANAGEMENT
- Motivate, recognize team members performance, maintain discipline and compliance to 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 interim review and end year performance review of each team member as well as their contribution to the team in time.
- Ensure job descriptions & training plan of people are in lign with the RM & NCE Lab organization
- Be backup of other TL's & NCE head when needed
OPERATION
- Ensure the daytoday operational planning and coordination in order to satisfy the client needs based on a monthly forecast.
- Organize daily meetings with team to followup on the planning and collect and give information's. Ensure that each one contribution is done in due time
- Ensure required corrective actions are taken and put in force.
- Implement, followup and communicate on KPI with its related corrective actions
- Inform customers and/or RM & NCE head if deviations from the dayto dayplanning occur.
- Be prepared and participate actively to weekly/monthly planning meetings, propose solutions, demonstrate creativity and proactivity in order to ensure adherence to plan and performance.
- Ensure that continuous improvement is part of daytoday activities of the laboratory
- Ensure the implementation of the continuous improvement strategy within the team.
- Ensure the lab infrastructure is maintained.
- Maximize the utilization of departments budget within given budget limits.
- Be accountable for a proactive collaboration with Pharmaceutical and Packaging Plants, QA/RA (validation), Metrology (calibration), BPS,
HSE (Security and Environment), DEV and biopilot plant, HR (Human Resources), oE (Centers of expertise), QC from other sites. - Coordinates the implementation of new NCE products (NPI) in the lab from an analytical, administrative and logístical point of view
QUALITY
- Ensure update of procedures and instructions.
- Ensure followup of corrective actions and preventive actions. Ensure audit readiness, participate to the preparation, the followup and the realization of audits.
- Ensure the followup 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
HSE
- Personally promote an effective EHS culture and lead by example
- Ensure a safe working environment to meet site safety objectives.
Interested? For this role we're looking for the following
education, experience
and
skills
- Bachelor / Master +5yrs in a GMP lab, 3+ years of management experience
- Experience in commercial areas of the pharmaceutical industry required (NCE).
- Must have experience in a GMP regulated laboratory.
- A very good management background is imperative. Capacity to cope with change management, high sense of empathy, capacity to motivate and make people grow through proper training and delegations.
- Ability to evaluate staffing and means versus project workload and translate into a clear action plan with an appropriates followup is essential. Must be able to manage multiple projects at the same time.
-
HSE, Operational excellence and compliance should be the 'must' reference of any operational decisions. - Capable to make one's proper decisions by utilizing strong analytical skills, troubleshooting and problem solving approach.
- Master interpersonal, verbal and written communication skills.
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