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Jobs or company...

Director, Quality Assurance

Salary undisclosed

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Company Description

Ergomed is a rapidlygrowing global clinical researchcompany. We perform clinical trials for rare and complex diseases.

Ergomed Plc is a public company on the London stock exchange.

The company boasted 40% growth in its revenues in its last report. This success is due to the hard work of our highly skilled employees and our subsequentreputation for excellence with our clients.

Job Description
  • Performing System Audits (in-house and on-site audits; which consist of audit planning / preparation, performing an audit and writing the audit report)
  • Act as a Liaison with Client’s Quality Assurance Unit/Person
  • Hosting of External Audits
  • Dealing with External Audit Reports – (evaluate auditors findings and responding accordingly)
  • Maintaining External Audits Records/Database
  • Writing and Reviewing SOPs on Quality Assurance
  • SOP Co-ordination
  • SOP Review for GCP Compliance
  • Archiving System Audits
  • Audits of Ergomed Sub-contractors in Clinical Trials Execution, such as Central Labs, Wholesale or Importation Agencies etc.
  • Phase I unit Audits
  • Reviewing Personnel Training Records (checking out staff training levels and documentation)
  • Up-dating Staff on GCP through Training Sessions
  • IT System Audits
  • Pharmacovigilance System Audits

Qualifications

Degree qualified in a Life Science related subject

  • Demonstrated experience working in a CRO environment with a focus ofGCP Quality
  • Risk-Based Quality Experience – Proven success anticipating industry trends and regulatory requirements to manage business risk, compliance, and sustainability
  • In depth knowledge of the drug development process and worldwide regulatory requirements
  • Excellent communication, managementand collaboration skills
  • Demonstrated ability to lead cross-functional teams
  • Ability to handle multiple tasks to meet deadlines in a dynamic environment
  • Effective organizational, presentation, documentation and interpersonal skills
  • Effective problem solving and decision making
  • Strong customer focus

Additional Information

All your information will be kept confidential according to EEO guidelines.
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