CAPA/ Quality Assurance Officer - 006/2018
Applications accepted until:
Number of Openings
- Bachelors Degree in Chemical engineering, Biological, Chemistry, Pharmaceutical Sciences or related field
- A minimum of 5 years experience in the pharmaceutical manufacturing environment, with working knowledge of pharmaceutical facilities, equipment, laboratories and systems is required.
Specific Operational Requirements
- The successful candidate will be required to work an 8 hour day between 08h00 to 16h00.
- The successful candidate may be required to work overtime to meet the business needs.
Key Performance Areas
- Design, implement and maintain formal CAPA programme.
- Incident investigations, root cause analysis, corrective and preventive actions, effectiveness monitoring.
- Quality Assurance Systems.
- Hands on experience with CAPA systems, especially with creating and implementing CAPA systems, performing root cause analysis and investigations.
- Convene and facilitate brainstorming meetings with the purpose of identifying root causes.
- Monitor and evaluate CAPA effectiveness.
- Experience with internal audits in a pharmaceutical manufacturing environment.
- Experience with electronic systems such as SAP-QM and Trackwise is preferred.
- Knowledge of CAPA system regulations and standards (e.g. ISO9001, ICH10) is preferred.
- Robust knowledge of Microsoft Excel and/or other trending tools.
- Project management skills are preferred.
- Ability to work independently with minimal supervision.
- Good team work & interpersonal skills.
- Ability to communicate with teams and encourage them to think in new and more process oriented ways.
- Ability to handle typical team conflicts.
- Ability to work with individuals across all levels of the company, including management.
- Strong analytical and problem solving skills.
- Good technical writing skills.
- Excellent attention to detail.