CAPA/ Quality Assurance Officer - 006/2018
Code/Reference:
006/2018
Applications accepted until:
2018-02-22
Number of Openings
1

Department

Quality Assurance

Employment Type

Permanent

Minimum Requirements

  • Bachelor€™s 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.

Additional Requirements

n/a

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.

Competencies

  • 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.
  • Confident
  • Self-motivated.