Permanent
Quality Manager
Quality Manager
Position Details
Position Title: Quality Manager
Location: Roodeplaat
Classification: Permanent
Employment Equity: Preference will be given to EE applicants
Location: Roodeplaat
Classification: Permanent
Employment Equity: Preference will be given to EE applicants
Closing Date: 18 February 2019
Please take note:
Only shortlisted candidates will be contacted. Deltamune may expire jobs at their own discretion.
Only shortlisted candidates will be contacted. Deltamune may expire jobs at their own discretion.
Deltamune (Pty) Limited is a world class South African-based biotechnology company. Our focus is on veterinary and public health offering both vaccines and diagnostic tests on a commercial scale. Deltamune’s veterinary vaccine range includes registered and autogenous vaccines for poultry, ruminants and other species.
We invite all suitably qualified and experienced candidates to apply for the following vacancy:
Position Purpose
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.
Key Accountabilities:
- Managing a small team of people within the QA/ QC department as well as managing and controlling the in-house testing laboratory.
- Ensure that manufacturing activities, the quality control system and its associated activities meet GMP and regulatory requirements.
- Implement, maintain and manage the total quality management system 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 vaccine 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.
- Able to integrate well with and to support production staff in the implementation of GMP and validation protocols.
Deltamune (Pty) Limited is a world class South African-based biotechnology company. Our focus is on veterinary and public health offering both vaccines and diagnostic tests on a commercial scale. Deltamune’s veterinary vaccine range includes registered and autogenous vaccines for poultry, ruminants and other species.
We invite all suitably qualified and experienced candidates to apply for the following vacancy:
Position Purpose
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.
Key Accountabilities:
- Managing a small team of people within the QA/ QC department as well as managing and controlling the in-house testing laboratory.
- Ensure that manufacturing activities, the quality control system and its associated activities meet GMP and regulatory requirements.
- Implement, maintain and manage the total quality management system 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 vaccine 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.
- Able to integrate well with and to support production staff in the implementation of GMP and validation protocols.
Position Details
Position Title: Quality Manager
Location: Roodeplaat
Classification: Permanent
Employment Equity: Preference will be given to EE applicants
Location: Roodeplaat
Classification: Permanent
Employment Equity: Preference will be given to EE applicants
Closing Date: 18 February 2019
Please take note:
Only shortlisted candidates will be contacted. Deltamune may expire jobs at their own discretion.
Only shortlisted candidates will be contacted. Deltamune may expire jobs at their own discretion.
Specifications
Qualifications:
- B.pharm and/ or BTech Quality or relevant qualification
Knowledge / Experience:
- Minimum 3-5 years’ experience in a QA management position
- Proven experience with ISO standard 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 highly advantageous
- Basic understanding of Regulatory Affairs advantageous
- Excellent computer skills (Advanced Excel and Word)
- Biosafety level 3 experience would be advantageous
Special working Conditions:
Candidates must be able to periodically work in rooms that require specialized manufacturing and biocontainment protective gowning and equipment.
Qualifications:
- B.pharm and/ or BTech Quality or relevant qualification
Knowledge / Experience:
- Minimum 3-5 years’ experience in a QA management position
- Proven experience with ISO standard 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 highly advantageous
- Basic understanding of Regulatory Affairs advantageous
- Excellent computer skills (Advanced Excel and Word)
- Biosafety level 3 experience would be advantageous.
Special working Conditions:
Candidates must be able to periodically work in rooms that require specialized manufacturing and biocontainment protective gowning and equipment.
- Apply On Company Site /
- https://deltamune.co.za/project/quality-manager/
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