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Principal QA Associate

Location: Limerick
Limerick City
Experience:5-7 Years
Job Type:Permanent
Salary:Not Disclosed
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Principal Associate – Quality Assurance

Main Purpose and Objectives of the Position:

  • Building state of the art, digitally enabled QMS and assure that the Quality System(s)/Program remains in a validated state and within regulatory commitments.
  • Provides Quality leadership, direction and governance for Limerick Change, Deviation Management, CAPA Business process incl. systems and compliance.
  • Assures consistent implementation of standards across the quality system.
  • Manages quality-related matters specific to quality systems & compliance.
  • Is responsible for approving appropriate quality-related documents.
  • Performs design and ongoing monitoring which includes but not limited to the following programs:
1) Monitoring of quality systems,
2) The self-inspection program
3) Verification of the effective implementation of key GMP programs
4) Review of systems that impact safety, product quality to ensure that they operate in a state of control.
  • Establishment, maintenance and management of a control system for and training of individuals in the specific Quality System and/or Quality Program assigned.
  • Provide coaching and mentoring to other QA reps, to provide appropriate and timely solutions to compliance in a business focused fashion.
Key Responsibilities:
  • Co-ordinates the site program to ensure compliance with the Global Quality Standards. Drives efficiencies in this process.
  • Ownership of Change and Deviation Management System, ensures implementation to the site of same and that it aligns with Global Quality Standards
  • Point of contact for generation of Notification to Management for exceptions to Global Standards
  • Report & escalate critical quality issues to appropriate level of quality management for resolution
  • Co-ordinate and report site compliance information and management review reports
  • Works cross functionally to ensure site contribution to Site Compliance Report is completed and provide site context and additional analysis/information as required
  • Working with Global Quality Systems group to ensure value-adding, right sized approach to Management Reviews and with QA Mgt to ensure management reviews are resourced appropriately
  • Business Process owner for Change Management, Trending and Activity Planning
  • Responsible owner of GMP documents/processes in relation to Change Control, Trend Analysis, Observation Management and GNP activity planning/tracking
  • Review and approval of key GMP documents such as GMP standard operating procedures as appropriate to area of responsibility
  • Responsibility for compliance with the Global Quality Systems & local procedures
  • Interpretation and application of emerging Global Quality System changes, Regulatory & GMP guidelines to the specific Quality System(s)/Program
  • Benchmarking of current and emerging initiatives in the specific Quality System(s)/Programs.
  • Review and approval of change controls, deviations and failure investigations.Co-ordinates Root Cause Investigator facilitator group
  • Communication and education of personnel in GMP requirements and regulations related to the area(s) of responsibility.
  • Provide training oversight on the system of Global Quality Standards/Company Quality Standards
  • Support site GMP inspections ensuring appropriate technical resources are identified to support inspections
  • Generation and reporting metrics such as observation metrics, backlog metrics, change control metrics to senior management and for incorporation in to relevant site trending scorecards
  • Participates in site deviation and change reviews
Basic Qualifications:
  • BSc, Msc, or PhD in Biotechnology, Chem, Eng or Science related discipline with appropriate experience
  • Minimum of 5 years’ experience in GMP operations
  • Ability to influence without authority
  • Demonstrated ability to lead and motivate in a team environment. Demonstrated ability to influence peers and across functions.

For further information contact Sinéad on [email protected] / +353 87 9500821


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