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

Requirements

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