- Quality Management System
- Organizing, maintaining and ensuring compliance to the company’s documented quality management system.
- Creating procedures and ensuring effective implementation.
- Carry out internal audit and help facilitate external audit.
- Co-ordinate calibration of equipment as needed.
- Identify GMP non-compliance and assist in enforcing GMP’s.
- Carry out quality related training with new and existing staff
- Identifying and action opportunities for improvement in the quality system
- Supporting best practice and development of organisation to achieve next level quality management system.
- Develop and maintain the Document Control process
- Ensure control of customer specifications
- Support the activities to ensure product quality is in compliance with customer specifications through the manufacturing process.
CAPA Management / Problem solving
- Using know problem solving technique, drive the CAPA process to investigate and manage non-conformance from internal and external sources.
- Work closely with production team to identify practical solution to identified issues to be implemented within expected time frames.
- Systematically analysis each process in relation to machines operating conditions, procedures /documentation and training of personnel.
- Based on the data and findings, update / generate the required documentation and training plans using the prioritisation from the Risk Assessment
- Support the introduction of new product or process introduction, to ensure it is new product or process is integrated into the quality system. This includes the change control process and validation of equipment and/or process.
- Ensure there is timely and accurate communication with internal and external personnel.
- Issuing of KPI and reports to the QA Manager
- Experienced quality professional with good hands on experience and willingness to get involved in day to day operations. Experience in root cause analysis and problem solving with a knowledge of lean practice and problem-solving tools an advantage.
- Good decision-making ability coupled and the ability to work on own initiative.
- Good interpersonal skills and organizational skills.
- Excellent attention to detail.
- Good communication skills.
Experience in the following area would be advantageous
- Change control process
For more information please either call me on 087 922 1136 or email me at email@example.com