- 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
- 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.
- 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.
- 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.
- 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
- Ensure timely input of data into the audit system
- 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.
- 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.
- Information Gathering
- Interrogating Information
- Offering Insights
- Taking Action
QA Auditor - Port Elizabeth, المملكة العربية السعودية - Aspen Pharma Group
وصف
Job purpose
Responsibilities
Vendor Management
Vendor Audit Management
Internal Audit Management
Governance, Risk & Compliance
Reporting
Requirements
Skills Required
Background/experience
Specific job skills
Competencies