Are you a QA Specialist with at 3 years API, Sterile/Aseptic manufacturing experience?
There is a super contract opportunity available in Cork with a well known Pharmaceutical API company for an initial 12 months - long term contract available
2 years consecutive QA Batch Release experience within same company in Ireland is essential for success in this role.
5 years experience overall in QA is ideal for this opportunity.
Apply today
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Role:
* Batch Record Review and material release (includingCoA) 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 Experience:
* 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.