Team Leader - Qaulity -Final Product Testing-00000NW2
Omschrijving
Department:
The Final Product Testing department situated at the Janssen Biologics Manufacturing site in Leiden (The Netherlands) owns the stability programs of commercial biological products manufactured by the Janssen Supply Chain (JSC) such as Remicade, Stelara, Simponi, ReoPro and products in process validation for commercialization such as CNTO328, CNTO136, etc. The services provided by the department also include release testing of biological drug substances and products. Currently approximately 43 employees are involved in the laboratory activities and another 10 are involved the management of the stability programs. For the laboratory activities the position of Team leader a.i. is vacant for team 3 with approximately 12 team members. Primary focus is day-to-day supervision and execution of daily tasks for a period of 6 to 9 months.
Responsibilities & Accountabilities:
- The Teamleader is accountable for the personnel in the team, their performance and development. Accountable for effective team performance by setting objectives in line with the GBSC CBV business cascade for direct reports.
- The Teamleader keeps oversight and identifies the need for particular personnel
- The Teamleader leads and defined team execution testing activities that are compliant with the cGMP and safety regulations.
- The Teamleader had the primary accountability for the planning, organization, day-to-day supervision and execution of daily tasks within the team and ensures the seamless transfer of activities.
- The Teamleader assures that the Quality Control assays are performed to the required quality and quantity as defined by planning, sets priorities in case of conflicting situations within the FPT department. Monitoring and reporting of all critical activities (e.g. process/delay of testing) to the manager. If necessary undertake actions independently.
- The Teamleader deals appropriately with any deviations, OOT and OOS results and corresponding CAPAs on a defined team level and notifies involved QC management. Coordination of investigations on a defined team level to achieve resolution in the minimum time and in compliance with GMP principles. And is responsible for all first line trouble shooting on assay or equipment failure.
- The Teamleader is responsible for following up on relevant KPIs, which includes but are not limited to, 6S/housekeeping, invalid assay rate, training status of the team, lead time of test results.
Kwalificaties
Qualifications, Education, Skills & Experience:
- Education minimum relevant HBO diploma
- At least 5 years of work experience
- Good interpersonal and organizational skills
- Proven leadership potential
- Good communication skills
- Shown to have excellent safety and GMP awareness and experience
- A quality and compliance service minded attitude and flexibility
More information:
Startdate: ASAP
Are you interested in this new challenge?
Please apply online
Primaire locatie: Europa/Midden-Oosten/Afrika-Nederland-Zuid Holland-Leiden
Organisatie: Janssen Biologics (7266)
Functie: Quality (Generalist)
Omschrijving
Department:
The Final Product Testing department situated at the Janssen Biologics Manufacturing site in Leiden (The Netherlands) owns the stability programs of commercial biological products manufactured by the Janssen Supply Chain (JSC) such as Remicade, Stelara, Simponi, ReoPro and products in process validation for commercialization such as CNTO328, CNTO136, etc. The services provided by the department also include release testing of biological drug substances and products. Currently approximately 43 employees are involved in the laboratory activities and another 10 are involved the management of the stability programs. For the laboratory activities the position of Team leader a.i. is vacant for team 3 with approximately 12 team members. Primary focus is day-to-day supervision and execution of daily tasks for a period of 6 to 9 months.
Responsibilities & Accountabilities:
- The Teamleader is accountable for the personnel in the team, their performance and development. Accountable for effective team performance by setting objectives in line with the GBSC CBV business cascade for direct reports.
- The Teamleader keeps oversight and identifies the need for particular personnel
- The Teamleader leads and defined team execution testing activities that are compliant with the cGMP and safety regulations.
- The Teamleader had the primary accountability for the planning, organization, day-to-day supervision and execution of daily tasks within the team and ensures the seamless transfer of activities.
- The Teamleader assures that the Quality Control assays are performed to the required quality and quantity as defined by planning, sets priorities in case of conflicting situations within the FPT department. Monitoring and reporting of all critical activities (e.g. process/delay of testing) to the manager. If necessary undertake actions independently.
- The Teamleader deals appropriately with any deviations, OOT and OOS results and corresponding CAPAs on a defined team level and notifies involved QC management. Coordination of investigations on a defined team level to achieve resolution in the minimum time and in compliance with GMP principles. And is responsible for all first line trouble shooting on assay or equipment failure.
- The Teamleader is responsible for following up on relevant KPIs, which includes but are not limited to, 6S/housekeeping, invalid assay rate, training status of the team, lead time of test results.
Kwalificaties
Qualifications, Education, Skills & Experience:
- Education minimum relevant HBO diploma
- At least 5 years of work experience
- Good interpersonal and organizational skills
- Proven leadership potential
- Good communication skills
- Shown to have excellent safety and GMP awareness and experience
- A quality and compliance service minded attitude and flexibility
More information:
Startdate: ASAP
Are you interested in this new challenge?
Please apply online
Primaire locatie: Europa/Midden-Oosten/Afrika-Nederland-Zuid Holland-Leiden
Organisatie: Janssen Biologics (7266)
Functie: Quality (Generalist)