Senior QA Specialist – Aseptic API

Category: Pharmaceutical

Fabulous opportunity for a Senior QA Specialist for a along term contract role in an aseptic Sterile API manufacturing Pharmaceutical company in Cork.

Essential requirements for this role include
+ 2 years consecutive experience within QA doing Bach Release within the same company
+ Ideally 4+ years experience over all in QA
+ Must be available for predominately an onsite role

Description

-Batch Record Review and material release (including CoA) to ensure compliance with GMP requirements.
-Quality review and approval of Master Batch Record (MBR) record for routine cleaning and process activities, including Automation recipe updates.
-QA Review and Approval of SOPs, Work Instructions and forms from other departments.
-Attendance at Daily/Weekly Operations led Team Meetings.
-Responsible for Gemba Walkdowns & Inspection
Readiness Walkdowns from a QA perspective.
-QA review and approval of Warehouse Shipping Picklist.
-Primary QA point of contact for Quarantine Shipments.
-Responsible for 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.

Education and Skills

-Third level Degree in a science or pharmaceutical discipline.
-A minimum of 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, EMEA and other authorities.