Vendor SME at Aspen Pharma Group

Description

• Monitor and support vendor related activities and technical agreements.
• Qualification of vendors in accordance with organization and regulatory requirements.
• Provide expert support to company and vendors sites to ensure successful regulatory and 3rd party audits.
• Related administrative tasks.

Requirements

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.

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 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