Quality Assurance Systems Officer

Quality Assurance Systems Officer at Demo SA, one of the world’s largest pharmaceutical manufacturers in injectable facilities, responsible for evaluations, audits, and monitoring of manufacturers, suppliers, and third-party sub-contractors.

Requirements

• Evaluations and revaluation of manufacturers, suppliers and third-party sub-contractors
• Perform audits according to the relevant standards on behalf of DEMO to manufacturers and suppliers
• Evaluate and analyze change control notifications from manufacturers and suppliers
• Issue Technical and Quality Contracts with manufacturers and suppliers
• Assist the regulatory department with providing the necessary documentation for supporting regulatory initial submission, variation and renewal applications
• Conducting the deviation investigations, the change controls and the reported complaints with their respective investigations
• Schedule, monitor, perform and archive Internal Inspections
• Implement and monitor the progress of the Corrective and Preventive Action Plan resulting from findings/observations of either Internal Audits and/or Audits from customers/organizations/authorities
• Issue the Quality Management Review Report
• Writes/revises master documents, Forms, Standard Operating Procedures (SOPs), specifications, etc. within the DEMO document management system
• Monitor facility pest control service

Benefits

• Competitive remuneration
• Continuous learning and development opportunities
• Friendly and challenging working environment