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QA Specialist MES

3 months ago

Cork, Cork, Ireland Cpl Full time

Kenny-Whelan (a specialist division of the CPL group) are hiring a QA Specialist rep for MES to work on contract at our US Global Biopharma site in Dunderrow Co. Cork

Contact Jenn Dinan on or email -

MUST ALREADY BE ELIGIBLE TO WORK ON CONTRACT IN THE REPUBLIC OF IRELAND- i.e have a valid work permit with 12 months permission + on it

Job Description

Main Purpose and Objectives of Position:

  • Provide Quality leadership, direction, and governance for MES and MES related systems.
  • Investigate and troubleshoot issues relating to MES and MES related systems.
  • Manage Quality-related matters specific to area (Quality system or Quality Program) of responsibility.
  • Approve appropriate quality-related documents. An approval signature confirms that company and GMP requirements have been met.
  • Carry out day-to-day activities in compliance with site safety policies and procedures. Promote and encourage safe practices and promptly report any safety concerns.
  • Promote and encourage Quality culture and promptly report any compliance concerns.

Scope: MES and MES related systems.

Educational Requirements: May hold BSc, MSc or PhD in Chemistry, Engineering, or related discipline.

Key Responsibilities:

  • Provide Quality direction and oversight for MES systems.
  • Participate in quality meetings keeping the group updated on initiatives within the QA owned GMP MES systems.
  • Contribution to the Quality Plan (GMP Plan) for specific Quality System/ Programme Initiatives.
  • Provide backup cover in the case of absence for any identified roles.
  • Assure consistent implementation of standards across the Quality System.
  • Assure that the Quality system(s)/Program remains in a validated state and aligned within regulatory commitments.
  • Interpretation and application of emerging Regulatory & GMP guidelines to the specific Quality System(s)/Program.
  • Support audit logistics from an MES perspective.
  • Support cross functional teams in audit preparation activities.
  • Carry out audit trails reviews as per site procedures.
  • Liaise with Global Quality Standard owner when deemed necessary.
  • Benchmarking of current and emerging initiatives in the specific Quality System(s)/Program.
  • Assess the Quality Impact of quality events associated with the area(s) of responsibility.
  • Review and approval of change controls, deviations, failure investigations, if applicable.
  • Report and escalate critical quality issues to appropriate level of quality management for resolution.
  • Review and approval of key GMP documents such as GMP standard operating procedures and CSV deliverables as appropriate to area of responsibility.
  • Review and approval of GMP documents associated with qualification and validation including IQ/OQ/PQ & validation documents for facilities, equipment, computer systems, GMP utilities and system periodic review reports as appropriate to area of responsibility.
  • Participation in the site self-inspection program of the area(s) of responsibility for compliance with the GQS & local procedures.
  • Monitoring of GMP compliance, GMP programs & systems by ensuring a regular presence in area of responsibility.
  • Communication and education of personnel in GMP requirements and regulations related to the area(s) of responsibility.

Key Attributes

  • Excellent attention to detail.
  • Experience working in cross functional teams and proven ability in decision making.
  • Demonstrates ability in critical thinking, data analysis, problem solving and experience in root cause analysis.
  • Strong organisational skills, including ability to follow assignments through to completion.
  • Strong understanding of Data Integrity and its applications
  • Self-motivated, positive and ability to work under pressure.
  • Demonstrates flexibility and adaptability to meet business needs.
  • Excellent interpersonal and communication skills (written and oral).
  • Demonstrates a continuous improvement mind-set.
  • Demonstrated initiative – able to work proactively without direct supervision, continuous improvement mind-set.

MUST ALREADY BE ELIGIBLE TO WORK ON CONTRACT IN THE REPUBLIC OF IRELAND- i.e have a valid work permit with 12 months permission + on it

All applications will be treated with the strictest of confidence.

Contact Jenn Dinan on - or call