Job Descriptions

Objective
Based in Annacotty , Limerick, the role will support the Uniphar Group Businesses in maintenance of the QMS along with the development and implementation of processes and systems to maintain compliance with the GxP requirement and ISO 9001 2015 requirements .The role will require a systematic and thorough approach to achieving regulatory compliance through the processes of deviation management, quality risk assessment, and change management.
Job Description

MAIN DUTIES & RESPONSIBILITIES

• Support the maintenance of the Electronic Quality Management System across the Uniphar Businesses and support the quality team in achieving KPI targets
• Support the quality y team in the management of deviations and CAPAs, risk management, and change control
• Additionally, the role will support as Deputy Responsible Person for the required Wholesale distribution authorisation (s)
• Assist in preparation for Regulatory and Client Audits
• Assist with ISO certification process for the Group entities
• Assist with the integration of QMS into Uniphar Business Units
• Assist with the compilation and analysis of data associated with the performance of the Quality System (e.g. Management Reviews)
• Support maintenance of Licenses including Manufacturing licenses and Wholesale Distribution Authorisation
• Assist with the training of business units on quality and compliance matters
• Support monthly reporting of metrics associated with the Quality Management System
• Accountable for completing activities within required timelines
• Proactively highlight any issues around compliance.
• Willingly accepts challenging assignments

Skills

• Quality Improvement
• Self Motivated
• Self Starter
• Time Management Skills

Experience

• 2