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]