Job Description

• Qualify material manufacturers and service vendors
• Conduct Manufacturer and Service Vendor cGMP Audits.
• Monitor and support supplier-related activities and technical agreements
• Execute supplier audit programs
• Provide expert support to company and supplier sites to ensure successful regulatory inspections
• Continuous compliance of corporate and supplier audit programs
• Support import and export permit applications/Section 22A permit applications/annual submission with SAHPRA and SAPs permit applications.

Vendor Management

• Qualify Manufacturers, including maintenance of the Approved Manufacturer List
• Conduct Risk Assessments, Classification of materials and annual manufacturer monitoring.
• Build and maintain supplier relationships to ensure timely audits, effective communication, and to resolve deficiencies/ concerns.
• Request Desk Audits, Quality Agreements and BSE/TSE/Nitrosamine/ICH statements
• Maintain the vendor matrix and update accordingly.
• Monitor vendor performance to established performance metrics and communicate performance issues.

Vendor Audit Management

• Conduct cGMP audits of manufacturers and service providers.
• 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 manufacturers.
• Provide recommendations on suitability and compliance of manufacturers.
• Propose follow-up remediation or CAPAs relevant to new manufacturers.

Internal Audits Management

• Coordinate, schedule and conduct quality audits of company sites to assess compliance to GMP, SAHPRA 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

• Bachelorxe2x80x99s degree in science or science-related field (example B. Pharm), with 4-6 yearsxe2x80x99 related experience or Post Graduate Degree or Diploma in Science or Science-related field with 1-3 yearsxe2x80x99 related experience.
• Registration with SAPC
• Knowledge of pharmaceutical GMP essential
• Industry recognized 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

Aspen Pharmacare