Quality Assurance Auditor (contract)

Responsibilities

• Planning and hosting of client audits and/or regulatory inspections of Novotech. Perform audits of investigator sites, vendors, Trial Master Files, internal processes and systems. Ensure that audit results are formally recorded and reported in a timely manner and that corrective / preventive actions are implemented effectively. Participate in the investigation and evaluation of quality events, root cause analysis, CAPA plan and follow-up activities. Evaluation of third-party vendors for clinical trial services. Review and approval of GxP computerised system validation documents. Ensure QA tracking systems are up to date Provide GCP and QA advice and training Develop and review written procedures and other documents for the Novotech QMS Generate and provide metrics, status and trend reports and other information, as required by management. Liaise with client, vendors and internal operational staff on quality aspects. Maintain an up to date knowledge of appropriate national and international GCP legislation and guidelines that affect the business.
• Minimum Qualifications & Experience: Tertiary qualifications in life science and/or related field. For Quality Assurance Auditor II, at least one year previous experience in QA or GCP field For Quality Assurance Auditor III, at least two years previous experience in GCP QA For Senior Quality Assurance Auditor, at least three years previous experience in GCP QA and is able to perform audits independently. Strong customer focus, attention to detail, excellent communication and interpersonal skills and the ability to multi-task and function independently as required. Good English proficiency
• Planning and hosting of client audits and/or regulatory inspections of Novotech.
• Perform audits of investigator sites, vendors, Trial Master Files, internal processes and systems.
• Ensure that audit results are formally recorded and reported in a timely manner and that corrective / preventive actions are implemented effectively.
• Participate in the investigation and evaluation of quality events, root cause analysis, CAPA plan and follow-up activities.
• Evaluation of third-party vendors for clinical trial services.
• Review and approval of GxP computerised system validation documents.
• Ensure QA tracking systems are up to date
• Provide GCP and QA advice and training
• Develop and review written procedures and other documents for the Novotech QMS
• Generate and provide metrics, status and trend reports and other information, as required by management.
• Liaise with client, vendors and internal operational staff on quality aspects.
• Maintain an up to date knowledge of appropriate national and international GCP legislation and guidelines that affect the business.
• Minimum Qualifications & Experience:
• Tertiary qualifications in life science and/or related field.
• For Quality Assurance Auditor II, at least one year previous experience in QA or GCP field
• For Quality Assurance Auditor III, at least two years previous experience in GCP QA
• For Senior Quality Assurance Auditor, at least three years previous experience in GCP QA and is able to perform audits independently.
• Strong customer focus, attention to detail, excellent communication and interpersonal skills and the ability to multi-task and function independently as required.
• Good English proficiency