Quality Manager

2 weeks ago

Durban, South Africa Quantum Recruitment Pty Ltd Full time

**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 9001

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.

**#* **Quality Support*

**#* **Quality Manager*

**#Pharmaceutical**

**#Healthcare**

**#Biotech**

**#Durban**

Ability to commute/relocate:

- Durban, KwaZulu-Natal: Reliably commute or planning to relocate before starting work (required)

**Education**:

- Diploma (required)

**Experience**:

- Quality Assurance: 5 years (required)
- Quality Manager: 5 years (required)
- Quality Support: 5 years (required)
- pharmaceutical/ healthcare/ biotech: 5 years (required)
- supplier/vendor auditing: 5 years (required)
- ISO 9001: 5 years (required)
- ISO Implementation: 5 years (required)
- ISO 9001 trained and has: 5 years (required)
- audit for ISO 9001 certification: 5 years (required)

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