Vacature Supervisor

a.i. Supervisor CPRm

• Quality
• Quality Control
• Leiden, South Holland, Netherlands
• .. 26 2567
• ID 24W

a.i. Supervisor Chemical, Physical and Raw Material team QC lab

As a part of the QC Lab situated at the Janssen Biologics Manufacturing site in Leiden, the Chemical, Physical and Raw Material (CPRm) testing team is responsible for execution of all chemical and physical testing using various techniques. The products tested ranging from early clinical up to commercial, covering process control, release and stability.

For our team, we are looking for an a.i. Supervisor that will lead the CPRm team for a period of 9 months and ensure the day-to-day operations of the team. The key responsibilities of the jobholder:

Responsibilities & Accountabilities:

• The Supervisor leads ~10 lab technicians and is accountable for the personnel in the team and their performance & development by performing the so-called 5 conversations. Accountable for effective team performance by setting and monitoring objectives in line with the QC Lab Organization business strategy.
• The Supervisor leads and defines team execution testing activities that are compliant with the cGMP and safety regulations. Furthermore, the Supervisor assures all test related elements are in place e.g. materials, equipment, trained personnel etc. in order to complete all testing activities in a timely manner.
• The Supervisor has the primary accountability for planning, organization, day-to-day supervision and execution of daily tasks within the team and ensures the seamless transfer of activities using the SmartQC tool.
• The Supervisor assures that the assays are performed to the required quality and quantity and sets priorities in case of conflicting situations within the QC Lab Organization. The Supervisor oversees all monitoring and reporting of all critical activities (e.g. process/delay of testing). If necessary, undertake actions independently and assures relevant action plan is in place. He/she participates in the weekly passive beeper duty of the department (once every ~7 weeks)
• The Supervisor deals appropriately with any deviations, OOT/ OOS results corresponding CAPAs and Change controls on a defined team level and notifies involved QC Lab management. The supervisor will be responsible for closure of all Quality issues. Additionally, the Supervisor ensures the proper coordination of investigations on a defined team level to achieve resolution in the minimum time and in compliance with GMP principles.
• The Supervisor is responsible for following up on relevant KPIs, which includes but are not limited to, 5S/housekeeping, invalid assay rate, training status of the team, lead time of test results, equipment breakdowns.
• The Supervisor is ensuring a team environment is created which supports continuous improvements, applying the Business Excellence and Faster Forward tools.

• Education minimum relevant HBO diploma (Bachelor's degree)
• 4-6 years of related work experience
• Proven leadership potential and willingness to develop themselves and others
• Knowledge or affinity with the relevant test methods
• Strong communication skills
• Shown to have excellent safety and GMP awareness and experience
• A quality, compliance and business minded attitude and flexibility
• Knowledge and affinity with Business Excellence and Faster Forward mindset

• Professional proficiency in English and Dutch

Heb je interesse in deze vacature en wil je graag op deze functie solliciteren? Neem dan contact op met Unknown via Unknown of Unknown. Of bezoek hun website Unknown.