- Develop recommendations to improve the quality system throughout the factory.
- Interpret quality control philosophy to all personnel within Company.
- Planning and implementation of QC system designed to ensure continuous production of products consistent with production requirements for all incoming materials and outgoing products.
- Formulate and maintain quality control and R&D objectives and coordinate objectives with other directorates.
- Ensure continuous control over materials, facilities, production (sterile and non-sterile area) and products and trial samples.
- Plan, organize, co-ordinate, direct, maintain, improve ,control Manage and evaluate R&D, Microbiology, Stability, Methodology and Quality Control tasks to be in accordance with established standards of National (MOH) and/ or International regulations (Pharmacopieas, GMPs, ICH and GLP and so on),regulations and guidelines. (the members of QC staff is 15 quality control members team and 2 R&D members team)
- The importance of the role is due to the QC department responsibility towards the company, the Toll manufacturing Companies and the Regulatory Agencies for quality control activities of pharmaceutical goods for human use (release , stability and customer complains)
- Management Review and environmental and personnel monitoring programs.
- Support regulatory and quality assurance activities. This will include assisting in investigation and root cause analysis of quality issues and helping to execute CAPAs & NEW CTDs
- Try to successfully meet clients requirements to maintain current and add new business.
- Participate in customer and supplier meetings &Investigate (and correct) customer issues and complaints relating to quality to Build collaborative relationships internal and external to the business
- Contribute to awareness of corporate direction, mission, aims and activities.
- Management of R&D programs to meet plan tasks((Start from the product core idea till releasing of the first 3 batches. including data collection, formulation development, composition editing, Methodology, stability, Scale-up, production problem solving and process validation).
- Responsible for ensuring compliance with QC policies , standards and procedures
- Try changes to Quality Control processes and materials to meet specifications and optimize efficiency.
- Responsible for execute Quality Compliance programs employing tracking and trending tools to assess root cause and risk management; including change control, auditing, Corrective Action Preventive Action (CAPA), vendor qualification, training, quality agreements, deviations, OOS & OOT
- Review, ensure and Approve that the following test
- Pathogenicity tests ( Detection of Pathogenic Micro-organisms).
● Biological assay test for antibiotics.
● Microbiological examination of water samples (Purified and Distilled water).
● Seed-lot maintenance of standard strains of micro-organisms.
● Anti-Microbial Effectiveness Testing of Preservatives in final finished products
● Efficiency test for disinfectants• Provides data and reports in support of the Quarterly Quality Systems )
●Validation for clean rooms in the sterile area.
● Validation for water treatment station, (Purified and Distilled water).
are complying the SOPs