QA Specialist New

2 weeks ago


Cork, Ireland CPL Full time

QA Specialist Senior

On behalf of our Client, Kenny-Whelan are hiring QA Specialist Senior for the Cork area for one of its Global Life Science companies in Cork.

Responsibilities:

-Batch Record Review and material release 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 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.

Qualifications/ Experience:

Ø Third level Degree in a Science or Pharmaceutical Discipline

-A minimum of 3 years of experience within the Pharmaceutical Industry -(sterile or aseptic environment)

-A working knowledge of quality processes and systems

-Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.

Skills/Competencies required:

Ø Build strong productive relationships.

-Demonstrates ability to work with teams and individuals.

-Seeks opportunities to grow and develop professionally.

-Uses best practices to improve business operations.

-Holds self-accountable for compliant and flawless execution.

-Takes personal responsibility for decisions that successfully build customer value

-Effectively manages and adapts to change

-Always demonstrate Integrity

-Ability to work independently, manage own time and

meet deadlines as appropriate

All applications will be treated with the strictest confidence

Please note that as this is a Contract role you need to be eligible to work in Ireland, hold a Stamp 1G or Stamp 4 Visa

Kenny-Whelan Contact:

For further information please contact Carmel Synnott on 00 353 21 4665405 / 087 7422268 or send your updated CV to [email protected]



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