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We are searching for the best talent for Manager Operations & Engineering CSC P& T to be in Beerse.

Purpose:

The CSC-P& T (Clinical Supply Chain – packaging & technologies) Beerse group is responsible for on time delivery of clinical supplies manufactured in CSC-Beerse. Within CSC-P& T Beerse primary and secondary packaging as well as JIT labeling is done in accordance with the cGMP regulations.

The operations support manager is the SME on the existing operational processes as well as the point of contact for complaint handling and event handling within operations.

Furthermore, the operations support manager leads a team off operational support functions such as and not limited to: Manufacturing process specialists and engineers.

You will be responsible for:

Complaint handling:

• Evaluate all clinical complaints related to Clinical Packaging & Labelling activities:
  • Evaluate impact assessment
  • Lead the root cause investigation
  • Define appropriate corrective and/or preventative actions
  • Document the complete investigation into the Trackwise complaint handling system.
• Coordinate all complaints related to the CSC organisation.

Engineering:

• Lead a team of engineers and manage the prioritization of the equipment and qualification road map
• Process owner of the CSC P& T engineering process

Quality:

• Work closely with QA CSC to have Complaints, NC’s and CAPA’s closed on time and according to the current standards.
• SME of operational procedures, and related NC’s & CAPA’s to continuously improve the quality & compliance performance of the plant
• Work closely together with QA CSC to review and update the complaint handling procedures, as required.
• Support internal and external audits as a spokesperson for the complaint handling process.

Continuous Improvements:

• Identify and execute CI projects and coach the MFG process specialist in process improvement
• Support the IVV process

Operations support:

• Responsible for day to day operations support related to all primary and secondary packaging activities as well as for JIT labeling processes.

EHS& S:

• Comply with all EHS& S policies and support EHS& S initiative

Qualifications / Requirements:

• Strong operational and planning skills, rigorous in execution and disciplined follow-up.
• Experience in deployment of lean manufacturing and continuous improvement programs, with demonstrated results, in a manufacturing and operations environment
• Excellent knowledge of GMP and EHS
• Excellent people management and leadership skills
• A proven ability to execute and get results through leading others

• Ability to work in a cross-cultural environment
• Master’s degree or equivalent based on experience. A background in pharmaceutical science, engineering science and/or production is an asset.
• At least 5 years of relevant experience in an operational pharmaceutical

Language requirements:

• Dutch
• English

Specific know how of systems

• SAP
• NGencodac
• COMET
• vTMF
• Microsoft office