Senior Clinical Quality Auditor performing internal audits, analyzing results, and collaborating with clinical operations teams at DaVita. Assisting leadership with daily operations of the Clinical Quality Auditing team.
About the role
- Supplier Quality Audit Lead managing GMP and Quality Systems compliance audits for GSK manufacturing suppliers. Responsible for maintaining supplier compliance and effective communication with stakeholders.
Responsibilities
- Performing GMP/Quality System assessments/audits of assigned suppliers
- Making risk-based recommendation on supplier GMP approval status
- Documenting assessments/audits in relevant systems
- Agreeing appropriate corrective and preventive action (CAPA) plans with suppliers
- Follow-up on the completion of CAPAs within agreed timelines
- Effective communication of assessment outcomes to internal and external stakeholders
- Ensuring audit-related documentation is effectively communicated
- Maintenance of auditee (supplier) profiles in data systems
- Collating identified risks and escalating high risk issues/situations
Requirements
- Relevant experience (ideally gained from the working in a highly regulated environment like Pharmaceutical Manufacturing)
- Degree in Life Science or other relevant disciplines
- Knowledge of current GMP requirements within major pharmaceutical markets
- Knowledge and application of the principles of the Quality Management Systems (QMS)
- Comfortable with verbal and written English.
Benefits
- Private healthcare
- Additional paid days off
- Life insurance
- Private pension plan
- Fully paid parental leave & care of family member leave
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