Quality Assurance Specialist
An experienced Quality Assurance Specialist is required to join our client in Cork, Ireland. The successful candidate will be responsible for ensuring the quality of pharmaceutical products and processes.
This is a 12-month contract role with opportunities for growth and development. We are looking for a highly motivated and organized individual who can work effectively in a team environment.
Main Responsibilities:
* Batch Record Review and Material Release to ensure compliance with GMP requirements
* Quality Review and Approval of Master Batch Records (MBR) and automation recipe updates
* QA Review and Approval of Standard Operating Procedures (SOPs), Work Instructions, and forms from other departments
* Attending Daily/Weekly Operations Led Team Meetings
* Gemba Walkdowns & Inspection Readiness Walkdowns from a QA perspective
* QA Review and Approval of Warehouse Shipping Picklists
* Primary QA Point of Contact for Quarantine Shipments
* Batch Book Filing & Archival
* QA Review and Approval of Quality Non-Conformance (NC) records and customer complaint non-conformance records
* Initiation and Ownership of QA Non-Conformance Records
* Responsible for Periodic Review of Quality Assurance and Quality Systems SOPs
* Primary Quality Point of Contact for Attendance at Root Cause Analysis Meetings
* Primary QA Point of Contact for the Returns Process
Requirements:
* Third Level Degree in a Science or Pharmaceutical Discipline
* 3+ years of experience within the Pharmaceutical Industry
* A working knowledge of quality processes and systems is desirable
* Demonstrated knowledge and application of industry regulations including those of FDA, HPRA