Manager Operations & Engineering CSC P&T

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
R&D Operations

Job Sub Function:
Clinical Supply Operations

Job Category:
Professional

All Job Posting Locations:
Beerse, Antwerp, Belgium

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

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 c...