Medical Consultant (German Speaking)

Job description

My client a Cork based Pharma company require a Medicines Consultant.
Fluency in German is essential.
The purpose of the Medicines Quality Consultant (MQC) role is to :
  • Support the implementation of quality systems strategy and activities to support Medicinal goals .
  • He/she will act and lead the integration of quality requirements into the business processes. 
  • The MQC will implement the quality plan & ensure consistency between the global & local requirements. 
  • This includes the draft of (SOPs) & assuring this system is aligned with quality & regulatory needs
  • The MQC will provide updates on all GxP trends and changes through the Quality Lead Team systems
  • He/she will act as a contact person regarding quality & business compliance concerns 
  1. Ensure local implementation of the Quality System
    1. Review regional and/or local SOPs versus global policies. Reviews SOPs & provides feedback.
    2. Approve regional and/or local procedures, job aids, forms, templates
    3. Recommend new procedures or changes to existing procedures where applicable.
    4. Provide quality oversight for compliance to SOPs
    5. Escalate compliance issues to management locally and globally as appropriate,
    6. Provide support for outsourced activities in alignment with internal standards
  2. Ensure inspection readiness and compliance to global, regional, and/or local regulations
    1. Assist in interpreting relevant regulations & guidelines & act as a contact person for affiliates
    2. Perform quality self-assessments
    3. Facilitate audits and inspections
    4. Coordinate audit responses including Trackwise system documentation
    5. Communicate and ensure inspection readiness requirements are in place (such as) :
    6. Organization & availability of documents such as training records, job descriptions etc.
  3. Ensure the implementation and maintenance of Quality Plan(s)
    1. Document the quality systems requirements ensuring clear accountabilities.
    2. Manage the quality plan(s).
    3. Provide updates to quality and business owners.
  4. Implement and manage Quality Systems
    1. Provide consultation on the integration of quality into business processes.
    2. Support the business on the application and facilitation of quality systems (deviations, notification to management, change control).
    3. Conduct root cause analysis and implement Corrective Action and Preventative Action (CAPA) process
    4. Ancilliary duties.
      1. Handles confidential information (patient privacy, confidential audits & regulatory inspections).
      2. Understand the roles and responsibility of the EU qualified person

What you'll need !

  • B.Sc/M.Sc  in a science or health care related field, Health professional, i.e., Pharmacist/Reg Affairs.
  • Fluency in German is essential.
  • 2-3 years (minimun) in quality and/or regulatorymedical affairs within private industry
  • Demonstrated ability to implement & apply quality systems in a regulated environment (e.g. GCP, GvP).
  • Some flexibility around work related travel required.

For full details on this role please call Colin on 021-4315770 or mail today !

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