Job Details
Experience Needed:
Career Level:
Education Level:
Salary:
Job Categories:
Skills And Tools:
Job Description
Job Functions : To organize the quality policy system in the factory, preparing the requirements of the quality system, supervising the quality system, applying GMP regulations and ensure that product can be supplied to the market in an adequate quality.
Job Responsibilities:
- Responsible for ensuring that the batch has been manufactured and tested in accordance with the requirements of its marketing authorization ,national legislation and cGMP.
- Responsible for authorizing planned changes in production, quality control in accordance with a defined system.
- Responsible for following up the routine work in QA department as per the manual and relevant SOPs.
- Responsible for evaluating the product quality review and give recommendation for improvement.
- The approval and monitoring of contract manufacturers and providers of other GMP.
- Administering GMP training for the whole factory.
- Evaluating all staff in the Quality Assurance department.
- Authorized to organize work in the Quality Assurance department.
Job Requirements
- Bachelor degree of pharmacy.
- 15+ years of experience in QA in Pharmaceutical field.
- SAP User.(is a must)
- Excellent management skills.
- Result- oriented.
- Problem solving & Decision making skills.
- Excellent understanding of the rules and guidance of cGMP.(EC/FDA).
- Excellent know-how of validation, documentation, internal auditing and training.
- Quality management system.
- Environmental management system.
- Occupational health and safety management system.
- Six Sigma.
