QA Specialist – API

Desired Skills: qa specialist,batch review,api

Description:

PE Global is currently recruiting for a QA Specialist on behalf of a leading pharmaceutical company based in Cork. This is an initial 12-month contract role.

Responsibilities:

• 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 Experience:

• At least 2 years exp in API in Ireland, need HPRA audit experience
• Third level Degree in a science or pharmaceutical discipline.
• A minimum of 3 years of experience within the Pharmaceutical Industry.
• Need experience in sterile or aseptic environment
• 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.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Audrey on 0214297900 or alternatively send an up to date CV to Audrey.mccarthy@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***