Qualified Person - Clinical

Overview

Our client is a global leader pharmaceutical company providing medicines across different countries. Providing a high level of quality and innovative pharmaceutical products. At the moment, we are looking for a Qualified Person in Waterford. For this position, the focus would be Regulatory and Clinical Trial Authorisation.

 

Responsibilities:

 

Ensure that all processes/stages in the manufacture, testing and packaging of products have been adhered to according to the Regulatory requirements.

Review proposals and related documentation for compliance with Regulatory approvals

Review and release batches according to shipment schedule ensuring all batches are in compliance

Ensure that all processes/stages in the manufacture, testing and packaging of products have been adhered to according to the Regulatory requirements

 

 

Qualifications, Experience & skills

 

Work experience in the Pharmaceutical Industry.

Qualified as Pharmacist or Graduate of Diploma in Pharmaceutical Manufacturing Technology or similar.

Good understanding of Production and Laboratory systems.

Auditing skills and / or lead auditor trained 

Excellent organisational skills

 

 

 

Nigel Bolger, General Manager, e-Frontiers Business - Your e-Frontiers consultant for this job

Nigel is a qualified Management Accountant with over 20 years of experience across a range of industries including manufacturing, telecoms, retail, software and recruitment both within the Corporate and SME sectors. He has held a number of positions up to Financial Director. Currently Nigel is General Manager in e-Frontiers Business. Nigel holds a BComm (UCD), MBS (Smurfit School of Business) and a TMITI from the Institute of Taxation.