Job Details
Experience Needed:
Career Level:
Education Level:
Salary:
Job Categories:
Skills And Tools:
Job Description
- 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 investigation deviations cases and approve suitable and applicable corrective and preventive actions and its implantation.
- Planning, organizing and controlling in process control (IPC) work and assure that cGMP and SOPs are properly followed throughout all manufacturing &/or packaging processes.
- Responsible for monitoring and evaluating the environmental monitoring program.
- Responsible for evaluation the stability study of the finished products.
- Responsible for Participation in management reviews of process performance, product quality and of the quality management system and advocating continual improvement.
- Responsible for establishing the system required for compliance with cGMP and international regulatory authorities &/or standards including formats that they follow.
- Follow up qualifications activities for production equipment, lab instruments and utilities.
- organize the quality policy system in the factory, preparing the requirements of the quality system, supervising the quality system, applying GMP regulations, approving review finished product batches & approving master batch records, specifications, test methods, SOPs and Material Lists.
Job Requirements
- Bachelor Degree of Pharmaceutical science.
- Not less than 10 years in a similar position in Quality Assurance field in a reputable pharmaceutical company.
- Excellent understanding of the rules and guidance of cGMP (EC/FDA).
- Excellent know-how of validation, documentation, internal auditing and training.
- Excellent communication skills.
- Strong Leadership and Managerial skills.
- Analytical mind and problem-solving aptitude
- Strong organizational skills.
- Detail-oriented.
- SAP User.
