Job Scope
Supervise analysis program required to evaluate bulk finished products, semi-finished, final finished product, active and
inactive ingredients for final approval for release or rejection of batches. And responsible for Effective implementation
of cGMP and GLP (Chemical Testing and Raw Material)
Supervise, monitor and coordinate the work of the stability section in the laboratory in compliance with GLPs and
cGMPs. including stability studies for company registered products (Post approval study) and work on new studies and
stop the ongoing studies in coordination with the Quality Assurance Department and the Regulatory Affairs
Department, in addition to all analytical activities related to stability samples studies and distribute analytical tasks for
analysts then to follow-up results and audit them (Stability)
Education
Bachelor’s degree in pharmacy, Chemistry or Chemical Engineering
Experience
A minimum 6 years' experience in quality control in pharmaceutical industries
Language
Proficiency written, read and spoken Arabic and English languages.
Planning And Coordination
Duties and Responsibilities (But not limited to):
3.1.1. Plan and program daily work for analysts to execute stability, raw material, and finished product analysis, according
to department plans, priorities, and emergencies.
3.1.2. Receive product samples and schedule submissions for stability programs.
3.1.3. Prepare monthly and daily work plans to ensure all testing and stability activities align with department objectives.
Supervision And Training
3.1.4. Supervise all activities of QC analysts, ensuring their adherence to cGMP, cGLP, and SOPs.
3.1.5. Review, check, and sign off on all analytical results and ensure timely and accurate data entry into laboratory
systems.
3.1.6. Supervise the training of QC lab employees and regularly update training records to ensure compliance with
procedures.
Stability Program Management
3.1.7. Supervise the receipt and management of stability product samples, ensuring correct labeling, storage, and
compliance with stability protocols and SOPs.
3.1.8. Monitor and record storage parameters (e.g., temperature, humidity) in stability chambers daily.
3.1.9. Ensure timely withdrawal and analysis of stability samples as per defined intervals.
Documentation And Compliance
3.1.10. Ensure all laboratory activities follow current cGMPs, GLP, and SOPs, and that all documentation is complete,
accurate, and submitted in a timely manner.
3.1.11. Initiate, prepare, and update SOPs relevant to the lab’s analytical and stability activities.
3.1.12. Check and sign all documents generated by the QC department, ensuring compliance with regulations.
3.1.13. Prepare reports related to lab activities such as out-of-specification (OOS), stability, deviation, and variation
reporting.
3.1.14. Ensure the lab is audit-ready at all times, performing self-inspections and audits as needed.
Instrument Calibration And Maintenance
3.1.15. Oversee the preventive maintenance and calibration programs for all laboratory instruments, ensuring validity and
reliability of test methods.
3.1.16. Validate volumetric standard solutions and working standards, ensuring quality control across all tests.
3.1.17. Ensure the lab is clean and maintained, and the quality of water used in the lab meets required specifications.
Investigation And Problem Resolution
3.1.18. Investigate and resolve OOS results, laboratory errors, and deviations in testing.
3.1.19. Manage any abnormal situations or deviations in lab processes, ensuring timely and effective corrective actions are
taken to avoid recurrence.
Data Analysis And Evaluation
2.5.5. Ability to manage, develop teams and goals effectively, influence and coach others in order to preserve a motivational and productive work environment.
3.1.20. Evaluate lab data and results, conducting statistical analysis and reviewing notebook records to ensure data accuracy. 3.1.21. Summarize, evaluate, and present analytical results for further decision-making. 3.1.22. Oversee the final approval and release process of finished products and raw materials, ensuring all necessary checks and documents are completed and signed off.
