Purpose
The role requires the individual to perform a series of tasks to guarantee the quality of our products and processes, and adherence to the Quality Management system. The responsible person will contribute to the organisation of quality control and process validation activities as well as interacting with various stakeholders in the business. This is not an exhaustive list of duties and responsibilities and the successful candidate may be required to carry out additional duties in line with your role and the organisation would expect you to be flexible in this regard. As we venture further on the global stage, we welcome team players who are energized by change and collective goals.
Responsibilities
The Objective of the QA Engineer is to:
- To liaise with Quality Management (QM), Production, Engineering, and Administration personnel to validate the different processes carried out.
- To liaise with Production, Engineering, and Administration personnel to perform quality controls and inspections.
- To contribute to the maintenance, assimilation, and consolidation of the company’s quality management system documentation including quality templates and work instructions.
- To aid in the creation and implementation of documentation and training regarding new processes within CSP.
- To aid in all the activities necessary for audit preparations.
- To investigate and troubleshoot issues.
- Report any quality, health & safety, or environmental issues to QM or senior management personnel.
- Assist in the company’s quality management system where priorities take place such as for NCR’s, internal & external audits, quality issues, or ongoing projects.
- Closely work with the QC Department in the regular review of QC documents, preparation of the annual review plan, and documentation distribution.
Daily and Monthly Responsibilities:
- Validation and improvement of production processes and equipment.
- Validation and improvement of work instructions.
- Assist in the organisation and documentation of CSP’s training programmes.
- Work in cleanrooms and gown appropriately.
- Update and maintain quality documentation on the quality management system
- Assist QM with validations, investigations, and improvement projects that are ongoing.
- Assist QM on quality-related projects such as NCR’s and lean six-sigma initiatives.
- Perform internal audits on production and engineering projects as part of the ISO9001:2015 management system.
- Assist in the design and implementation of CAPA plans.
Requirements
- Minimum of one year experience in a pharmaceutical/medical device/health and safety role.
- Level 7 degree or higher in a Science or Engineering discipline
- Level 6/7 qualification in Quality, Process Validation or related discipline
- Previous experience in the validation of manufacturing processes
- Excellent skills in Microsoft Word and Excel
- Excellent written and verbal communication skills
- Excellent documentation skills (creation, formatting, archival, retrieval)
- Excellent planning and prioritizing skills; capacity to plan ahead to ensure tasks are completed on time
- Experience in a GMP facility, in a documentation role is desirable.
- High attention to detail, and strong personal reliability.
- Minimum of one year experience in a pharmaceutical/medical device/health and safety role
- A full driving licence and ideally car ownership is required for this position as the successful candidate will need to travel between two production sites (about 10Km distance in between).
- Familiarity with SAP or other ERP system.
Favorable Working Backgrounds:
1: Pharmaceuticals and Biotechnology
Drug manufacturing, Medical Device, Biotechnology firms
2. Manufacturing
Automotive , Electronics, Aerospace
3. Food and Beverage
Food processing plants, Beverage production, Dairy products
