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 of GCP 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, management and 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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