QA Auditor - Port Elizabeth
Aspen Pharma Group
Job purpose Approve local suppliers. Monitor and support supplier-related activities and technical agreements. Coordinate and execute internal and supplier audit programs. Provide expert support to company and supplier sites to ensure successful regulatory inspections. Continuous compliance of corporate and supplier audit programs Related administrative tasks Responsibilities Vendor Management Review and approve new suppliers. Interpret, implement, and maintain supplier technical agreements. Build and maintain supplier relationships to ensure timely audits, effective communication, and to resolve deficiencies/ concerns. Implement principles, processes, and tools to manage suppliers. Monitor compliance of supplier activities and contracts to GMP standards and technical agreements Monitor vendor performance to established performance metrics and communicate performance issues. Vendor Audit Management Coordinate, schedule and conduct supplier and service provider audits to assess compliance. Issue audit reports and follow up on responses to audit findings, including CAPA plans, close out supplier audits. Perform due diligence visits/audits of potential new suppliers. Provide recommendations on suitability and compliance of suppliers. Propose follow-up remediation or CAPAs relevant to new suppliers. Internal Audit Management Coordinate, schedule, and conduct quality audits of company sites to assess compliance to GMP, MCC and international standards. Conduct statutory internal audits as required by local authorities. Prepare audit reports and review audit findings with unit managers. Assist in audit investigations and provide input into CAPA plans. Perform follow-up on unit actions plans and close out audits. Prepare, update and review proposed changes to SOPs. Governance, Risk & Compliance Provide input and evaluate changes to audit system to improve quality of audit. Provide technical and regulatory guidance to internal and external stakeholders to ensure overall quality and compliance. Ensure compliance of company and supplier audit programs Reporting Ensure timely input of data into the audit system Skills Required Background/experience Bachelor’s degree in science or science-related field, with 4-6 years’ related experience or Post Graduate Degree or Diploma in Science or Science-related field with 1-3 years’ related experience Industry recognised audit qualification preferred. Experience in GMP regulated industry in a QA and auditing role. Specific job skills Excellent knowledge of good manufacturing regulations in pharmaceutical industry Pharmaceutical standards and compliance requirements Ability to interpret and implement policies, processes, and objectives. Ability to operate and audit within all global cultures. Project management. Competencies Information Gathering Interrogating Information Offering Insights Taking Action
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