Quality Support/ Quality Manager - Durban, South Africa - Quantum Recruitment Pty Ltd
Description
Key Performance Areas:
- Managing Vendor Questionnaires which customers submit to our company
- Facilitating customer audits. They may or may not accompany the auditor for these overseas onsite audits of our manufacturers, however they will need to facilitate and assistance with travel coordination and audit arrangements for the customers
- Managing close out of customer audits. This will be for the action of our manufacturers, but the person will need to monitor the action and close outs so that they are completed within the deadline
- Managing Change Control Notices received record these and issue to relevant customers
- Managing Change Control Notices received record these and issue to relevant customers
- Specification / Item Control. Complete and maintain the database of all our active items and drawings
- Managing controlled Item Set up
- Implementing and managing External Vendor controls
- Managing close out of Customer Complaints/ Internal Action Requests
- Oversee Documentation control
- We would require that they assist in the implementation and continual management of the Quality Management System
Requirements:
- Matric
- Tertiary or relevant qualification would be advantageous
- At least 5 years' experience in Quality Assurance within the pharmaceutical/ healthcare/ biotech manufacturing industry
- Knowledge of supplier/vendor auditing advantageous.
- Experience in quality management systems ISO 900
- ISO Implementation is underway for our company, and we would ideally want someone who is mínimally ISO 9001 trained and has experience and understanding of this standard. We intend to schedule an audit for ISO 9001 certification this year.
Salary:
Market related
Education:
- Diploma (preferred)
Experience:
- QA in pharmaceutical/ healthcare/ biotech: 5 years (preferred)
- supplier/vendor auditing: 3 years (preferred)
License/Certification:
- ISO 9001 (preferred)
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