Change Leader
Contracting – Walloon Brabant
#laboratory #productrelease #procedures #changes #requirements
Our partner is currently looking for a Change Leader to join its team. This international company is well-known for its pharmaceuticals.
What are your responsibilities?
As a Change Leader, you will be in charge of the management of local specification to allow laboratory testing and Product Release, and you will ensure local specification are compliant to market and regulatory requirements. To be successful in your role, here are your tasks:
Operational:
- Manage local specifications changes (create / update) according to procedures in place and business needs.
- Coordinate the creation/review of the specification ensuring that the content is defined and developed with the involvement of the appropriate experts / stakeholders to grant compliance to regulations and related file.
- Checks the progress of the change with stakeholders and escalates any risks in the initially planned implementation schedule.
- Ensure communication between subject matter experts and stakeholders. Ensure all information is provided to the specification author to write local specification document in ECMS.
- Informs Lims partner when the specification is in status issued in ECMS and ensures to provide on time specific information allowing Lims configuration /process to operate with efficiency.
- Ensure planning and coordination in order to satisfy the client needs. Organize or participate actively to weekly/monthly planning meetings, propose solutions, demonstrate creativity and pro-activity in order to ensure adherence to plan and performance.
- Ensure local specification implementation is in alignment with global specification status.
Quality:
- Implement, follow-up and communicate on KPI.
- Ensure the continuous improvement of the activity.
- Ensure update or creation of related procedures and instructions.
- 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 deviations and appropriate root cause analysis to address the right action plan.
HSE:
- Apply the company's Health and Safety policy
- Ensure a safe working environment to meet site safety objectives
Who are you?
You hold a master’s degree in a scientific domain. You have a proven experience in a GMP/laboratory environment. You have also an experience in data management (LIMS, SAP). You speak fluently French and English.
What can you expect?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Marie Rossenfosse, [email protected]
