| *Bachelor’s degree in Chemical Engineering, Chemistry, Biochemistry, Biology, or Pharmaceutical Science, min. 2 years’ experience supervising/leading teams, min. 5 years’ experience in the Pharmaceutical Manufacturing environment, and 2 years’ experience as an auditor of quality systems * |
| Location: |
Pinetown |
| Description: |
A pharmaceutical company is seeking a Quality Assurance (QA) Systems Lead to join their QA Department. The QA Systems Lead will be responsible for ensuring excellence in the QA Department and organizational compliance with cGMP, ISO13485, and regulatory requirements, through effective performance of Quality Management (QMS) functions: by coordinating the annual internal, external, and vendor audit programmes, through planning, executing, and reporting; implementing and managing systems and tools to ensure that process risk assessments are planned and conducted, all changes at the company are documented and processed, and documents and records are effectively controlled; maintenance, reporting, and frequent review of the various QMS systems, processes, and procedures that are in keeping with the QA Department objectives and industry standards; identifying and reporting on quality metrics for each system at review meetings and forums; and implementing continuous improvement measures in the QA Department. |
| Key Requirements: |
A Bachelor’s degree in Chemical Engineering, Chemistry, Biochemistry, Biology, or Pharmaceutical Science, or related technical or scientific field. A minimum 2 years’ experience supervising or leading teams; a minimum 5 years’ experience in the Pharmaceutical Manufacturing or Pharmaceutical Quality environment, with working knowledge of pharmaceutical facilities, equipment, laboratories, and Quality Management Systems; and a minimum 2 years’ experience as an auditor of quality systems (ISO9001, ISO13485 and/or GMP). Experience with ISO13485:2016 would be an advantage. |
| Additional Requirements: |
Confidence and self-motivation; excellent attention to detail; ability to work with individuals across all levels of the company, including management, to handle typical team conflicts, to communicate with teams and encourage them to think in new and process-oriented ways, and to work independently with minimal supervision. Furthermore, good technical writing, strong analytical and problem solving, and good team-work and interpersonal skills are required. |
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| *Only candidates that meet all the requirements should apply |
| **Please quote “QA Systems Lead (K301)” in the subject line |
| ***Only candidates that are shortlisted will be contacted |
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