Quality Manager

1 week ago

Pretoria, South Africa Neoc_People Full time

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 SOPs 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

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