Medicines Quality Consultant

08 Apr 2020

Are you a Nurse or Pharmacist, looking for a change in direction?

Do you have a keen interest in Quality Control and would love to see yourself being part of one of the biggest names in Pharmaceuticals?

I am delighted to partner with one such giant on their search for a Medicines Quality Consultant for their Centre of Excellence in Cork. This role will support the development and implementation of quality systems strategy and activities to support Medicines Development Unit and Trial Capabilities goals and objectives for assigned countries.

In support of this mission, the MQC will act as quality consultant and leader in integrating the quality requirements into the business processes of Trial Capabilties (such as activities related to trial set up, trial maintenance including regulatory and institutional submissions). The MQC will implement the quality plan and ensure consistency between the global requirements and local requirements. This includes the implementation of Standard Operating Systems (SOPs) and assuring that this system is aligned with appropriate quality and regulatory requirements. The MQC will provide updates on internal/external GxP trends and changes through Integrated Quality Lead Team (IQLT) .The MQC will act as a contact person regarding quality and business process compliance concerns between the function supported and global.

A diverse and vital role, a day in the life is likely to include the following;

  • Ensure local implementation of the Quality System
  • Review regional and/or local SOPs versus global policies. Reviews SOPs documents and provides feedback.
  • Approve regional and/or local procedures, job aids, forms, templates.
  • Recommend new procedures or changes to existing procedures where applicable.
  • Provide quality oversight for compliance to SOPs
  • Escalate compliance issues to management locally and globally as appropriate,
  • Provide support for outsourced activities in alignment with internal standards
  • Ensure inspection readiness and compliance to global, regional, and/or local regulations
  • Assist in interpreting relevant regulations and guidelines and act as a contact person for global and affiliates
  • Perform quality self-assessments
  • Facilitate audits and inspections
  • Coordinate audit responses including Trackwise system documentation
  • Communicate and ensure inspection readiness requirements are in place; e.g. organization and availability of documents such as training records, job description, backroom and/or front room organization, etc.
  • Ensure the implementation and maintenance of Quality Plans
  • Document the quality systems requirements ensuring clear accountabilities.
  • Manage the quality plans.
  • Provide updates to quality and business owners.
  • Implement and manage Quality Systems
  • Provide consultation on the integration of quality into business processes.
  • Support the business on the application and facilitation of quality systems (deviations, notification to management, change control).
  • Conduct root cause analysis and implement Corrective Action and Preventative Action (CAPA) process
  • Drive trending of metrics to improve processes and compliance
  • Analyze trends, identify areas of weaknesses/gaps and recommend corrective actions.
  • Monitor completion of deviations, CAPA related to deviations and change controls.
  • Monitor completion of audit responses through metrics.
  • Provide updates to management.
  • Share key learning to drive simplification and replicate best practices in the region and globally.
  • Coordinate quality improvement initiatives.
  • Seek and implement simplification and process improvement.
  • Other responsibilities
  • Understand the handling of confidential information (patient privacy, confidential audits and regulatory inspections).
  • Understand the roles and responsibility of the EU qualified person

The ideal candidate will

  • Hold Bachelors or Masters' Degree in a science or health care related field, Health care professional, i.e., Pharmacist, Nurse.
  • Three years' experience in quality and/or regulatory/clinical operations/medical affairs.
  • Demonstrated ability to implement, interpret and apply quality systems within a regulated work environment (e.g. GCP, GvP).

To hear more about this excellent opportunity, please apply with your most recent CV without delay!

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.


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