Job Description
A Senior QA Specialist –is required by CareerWise Recruitment to join our based Cork based pharma manufacturing client - Need experience in sterile or aseptic environment. 12-month initial contract role.
ROLE
* 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.
JOB 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,