Mohammed Atallah Abu Hardan

• Review and approve of SOPs related to IPC Department.
• Assess, Review and Approve the QMS Tasks which are assigned to IPC.
• Follow up with IPC Sr. Supervisor that IPC staff are trained on the job they are doing beside the training that will enhance the continuous improvement of them.
• follow up with IPC Sr. Supervisor to make sure that BMR & BPR are Released on Time, and the steps are followed with no deviation.
• Perform GMP inspections and Internal Audits within Riyadh Pharma.
• Follow up with IPC Sr. Supervisor that the daily activities of the IPC staff are Organized and the man power based on production needs, the timely closing of the IPC Reports,
• Follow up GMP regulations and procedures for Quality Management System.
• Oversee in-process quality checks during manufacturing, packaging, and validation activities.
  Ensure compliance with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).
• Train and supervise QA staff. Evaluate personnel training and ensure its effectiveness.
• Conduct risk assessment studies.
• Decide regarding the non-conformances and IPC Notifications that are identified during routine operations and report the same to the Quality Assurance Director.
• Approve the AQL Reports for the manufacturing & Packaging processes.
• Participate in the investigation procedure for any deviations, incidents, complaints, PQRs and OOSs in addition to QMS tasks (TCC, Change Controls, CAPAs, Document Approvals) and Quality Risk Management.
• Participate in the internal complaints related to materials defects (i.e.: Raw or Packaging materials) in addition to the received bulk.
• Continuous meeting with the Managers to determine the department goals and the required strategies to achieve these goals.
• Participate in White Paper Meetings which are related to Quality Assurance & IPC Dept.
• Ensure that all department resources are available to achieve department and company goals:

- Manpower as number and skills

- Instruments availability.

• Participate in resolving Quality problems related to the products , processes , personnel ,…etc
• Follow up the Monthly KPI of IPC Department.
• Follow up the internal tours for routine checking of IPC activities for the findings and take corrective and preventive actions accordingly.
• Follow up with the production Managers the status of raised IPC Notification
• Review the attendance Report issued by HR once shared by them.
• Reporting to QA Director.

• handling of all managerial responsibilities of the department in the case of the QC Manager's absence as well as Attending the regular technical, productivity and quality meetings.
• Ensured the efficient and professional functioning of all sections in the Quality Control department, as well as managing all of the department's sampling, testing and analytical requirements while reporting directly to the QC Manager.
• Acted as a key participant in the technical meetings and ensured the efficient coordination of QC operations in accordance with other departments and sections.
• Played a key role in the company's successful passing of several audits including IMB Audit, Abbott Laboratories audits, Norgine Pharma audits, Merck audit, Saudi FDA audits.
• Maintained a top-functioning Quality System that meets the intended regulatory requirements and aligned with the company's mission and quality strategies through continuous observation of the quality system, identification of deviations and nonconformance events, reporting, analysis and appropriate action.
• Handling & Follow up of Change Controls & internal complaints through QMS (Quality Management System) which are related to Quality Control.
• Handling of OOS, OOT and Laboratory incidents which is related to QC analysis.
• Ensured the implementation of an effective documentation system as a support for the quality elements in addition to ensuring compliance with GMPs and GLPs and ensuring their application to the analysis procedure.
• Appointed as member of some of the company's committees including the Internal Auditing Committee, the Troubleshooting Committee, and the Risk Assessment Committee.
• Handling of QRMs within Quality Control Department.
• Creating & Managing of Skip testing and Outsource testing Systems of Raw Materials.
• controlling chemicals / standards/ impurities /HPLC&GC Columns which are related to analysis of raw materials and finished products as well as searching and requesting the most suitable grades of the same.
• Technical Communications with the Manufacturers / Suppliers of Raw Materials.
• Responding to Internal and External Regularity inquires which are related to Quality Control.
• Responding to All Regulatory Requirements for Re-newel Purposes including commitment and clarification letters which are related to Quality Control.

• Supervising Quality Control Operations: Overseeing daily activities in the quality control department to ensure compliance with established standards.
• Training Staff: Mentoring and training quality control personnel to maintain high standards.
• Analyzing Data: Preparing reports and analyzing quality control data to inform management decisions.
• Handling Complaints: Investigating customer complaints and addressing non-conformance issues as Quality Control part.
• Stability Testing: Managing stability studies to ensure product efficacy and safety over time.
• Documentation: Maintaining detailed records of all QC activities, including batch records, test results, and deviations.
• Raw Material Testing: Supervising the testing of raw materials, intermediates, and finished products to ensure they meet specifications.
• Change Control: Evaluating and implementing changes in QC procedures or equipment while ensuring compliance with regulatory requirements.
• Risk Management: Identifying potential risks in the quality control process and implementing preventive measures.
• Audit Preparation: Preparing for and participating in internal and external audits.
• Cross-Department Collaboration: Working closely with production, R&D, and quality assurance teams to address quality issues and improve processes.
• Monitored employee performance to identify areas requiring additional training or development efforts.

• Supervised the routine analysis of starting materials using a variety of testing devices and procedures to maintain product quality. Provided technical and analytical consultancy during the analysis process, as well as preparing and updating specifications, methods of analysis and calculation sheets.
• Creating, Updating and Reviewing the SOPs which are related to Raw Materials Section.
• Supervised the requisition, handling and follow up the Primary Reference standards as well as Internal Working Standard selection, certification, re-certification & Disposal.
• Taking part in the interviewing, recruitment and training of new members of staff in the QC department.
• Supervised the Analytical Method Transfer for both Raw Materials & Finished Products with R&D Department as well as with other Companies (Like: Mylan Company Ltd).
• Full Handling of Seven projects with External Company (Mylan Company Ltd) for all requirements which are related to Raw Materials Part.
• Conducting daily meeting with Raw Materials Team for technical issues or any other issues. Follow up with the team on daily basis to be fully updated regarding the materials status.
• Technical communication with Manufacturers /Suppliers of Raw Materials for technical observations which are related to Raw Materials.

• Sampling of Raw Materials.
• Routine analysis of starting materials using a variety of testing devices Like HPLC, UV, Dissolution, IR, Karl fisher, pH, Oven & Particle Size Instrument,… etc.
• Working standard certification against Primary Reference standard.
• Routine Analysis for Potable Water, Purified Water & Water for Injection.
• Requisition and Handling of chemical reagents which are required for Analysis in Quality Control Department.