Aspen Port Elizabeth Vacancies – Vendor SME

Job Description:

Monitors and supports vendor related activities and technical agreements. Does qualification of vendors in accordance with organisation and regulatory requirements. Provides expert support to company and vendors sites to ensure successful regulatory and 3rd party audits . Completes related administrative tasks.

Job Responsibilities:

• Request and review vendor documentation and statements
  • Desk Audit Questionnaire
  • Nitrosamine Statements
  • ICH Q3D statements
  • ICH Q3E statements
  • BSE/TSE Statements
  • Any other relevant documents
• Conduct Annual Vendor Risk Assessments
  • Conduct API; Primary/Printed Packaging Components and Quality Critical Consumables Risk Assessments as per company and regulatory expectations
  • Conduct Excipient Risk Assessments as per as per EU Guideline 2015/C95/02
  • Based on the outcome of the Risk Assessments, determine the Minimum Vendor Requirements
• Conduct Vendor Classification of Vendor Items
  • Review vendor classification documents, including number of batches received and tested, review of deviations, OOS, rejections, etc.
  • Review regulatory and statutory compliance of vendors
  • Based on the classification outcome, classify vendor items as not-well-known, well-known or validated
  • Promote or demote vendors based on monitoring outcome
• Conduct Annual Vendor Monitoring
  • Review vendor performance in terms of quality metrices such as  rejects, deviations, OOS, etc
  • Review vendor GMP compliance status
  • Review vendor classification and promote or demote as applicable.
  • Review and approve changes to audit system

Job Requirements:

• Bachelors’ degree in Science or Science-related field, with 4-6 years related experience or Post Graduate Degree or Diploma in Science or
• Science-related filed with 1-3 years’ related experience
• Experience in GMP regulated industry
• Experience in GMP regulated industry in a QA and auditing role

Specific job skills

• Extensive knowledge of good manufacturing regulations, quality assurance, and raw material and packaging material
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives
• Ability to interpret raw material and packaging material specifications
• Project management
• At least 2 years experience in vendor qualification practices

Competencies

• Information and data gathering
• Interrogating Information
• Offering insights
• Taking Action
• Networking

Job Details:

Company: Aspen Pharma

Vacancy Type:  Full Time

Job Location: Port Elizabeth

Application Deadline: N/A

Apply Here

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