Quality Manager

1 week ago


Pretoria, South Africa NEOC Digital Full time

The Quality Manager role is to manage the Total Quality Management System of the Animal Health Products

Business Unit, to supervise the QC Laboratory and to take care of many of the aspects relating to quality

assurance, quality control and validation throughout the Business Unit
- Managing a small team of people within the QA/QC department as well as managing and controlling the in-house QC testing laboratory.
- Ensure that manufacturing activities, the quality control system and its associated activities meet GMP, ISO 9000 and regulatory requirements.
- Implement, maintain and manage the Total Quality Management System (ISO 9000 & GMP) including corrective and Preventative Action (CAPA). Management.
- Audit and Quality Risk Management.
- Performing annual Quality Management Reviews.
- Updating, implementing and improving Standard Operating Procedures relating to all quality processes and reviewing manufacturing SOP’s for compliance.
- Establishing a Master Validation Plan and compiling validation methods for all critical manufacturing processes.
- Maintain the Site Master File and Quality Manual.
- Maintain Product Specification Master Files and ensure specification sheets of products are always up to date.
- Maintain Staff Competency and Training Master Files.
- Manage the Vaccine Batch Release process.
- Establishing and improving existing raw material, intermediate and finished product specifications.
- Managing and controlling budgets for the Quality Department.
- Training staff in all relevant areas in order to attain and maintain suitable quality standards.
- Arrangement for calibration and validation of key equipment within scope of operations.

Qualifications:

- B.Pharm and/or BTech Veterinary Technology/Biotechnology or Bachelor of Science Degree or higher Quality Management Qualification a must.
- Internal auditing certificate a must (ISO 9000 and/or GMP).
- Minimum 3-5 years’ experience in a QA management position.
- Proven experience with ISO 9000 implementation and GMP quality systems.
- Highly effective in managing a quality documentation system.
- Experience in productively managing people, projects and tasks.
- Proven experience in the implementation of validation protocols..
- Basic Understanding of Regulatory Affairs advantageous.
- Biosafety level 3 experience is a plus

Experience
- Minimum 3-5 years’ experience in a QA management position.
- Proven experience with ISO 9000 implementation and GMP quality systems.
- Highly effective in managing a quality documentation system.
- Experience in productively managing people, projects and tasks.
- Proven experience in the implementation of validation protocols.
- Basic Understanding of Regulatory Affairs advantageous.
- Biosafety level 3 experience is a plus

For more information please contact:

- Kagiso Madiba


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