The position is responsible for carrying out a diagnosis between current DI system and changes in the requirements of the authorities. Develop existing system plan by making an inventory of the potential gaps within the manufacturing systems. Define mitigation actions for the identified gaps. Develop the short- and medium-term remediation plan. Driving improvements in data management and data integrity within manufacturing in terms of culture of data integrity and will oversee the optimised implementation of all computerised systems. This position is responsible for monitoring and supporting the data management to all applicable GMP standards. The DI and CS manufacturing role may lead investigations, resolve potential manufacturing issues, recommend and implement changes as necessary in order to mitigate risks associated with data integrity and data management.
Responsibilities: Maintain validation philosophies, master plans, and procedures required to drive the validation lifecycle of production recipes Work in conjunction...Apply For This Job
This is an 11- month fixed-term contract with our pharmaceutical client in Carlow. Purpose: The successful candidate will join the...Apply For This Job
This is an 11-month contract. Purpose: The role of Quality Control (QC) Instrumentation Systems Specialist operates as part of a...Apply For This Job
This is a 12-month initial contract. Responsibilities: Operate as an MES eBR author supporting the site(s) MES Recipe introduction. The...Apply For This Job
Purpose The Data Integrity (DI) and Computerised Systems (CS) specialist role has responsibility for the oversight and improvement of Quality...Apply For This Job