Quality Assurance Team Lead (hybrid)
RK3368
Contract - 12 months
Cork



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



Duties:

• 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.

• 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.