Job Description

In Process Control Quality Manager (New Capital)

The In Process Control Quality Manager is responsible for leading and governing all in-process control (IPC) activities within the manufacturing site, ensuring consistent GMP compliance, process control activities which directly or indirectly impact the quality of the product manufactured

in GEPD New Capital Manufacturing site.

Key responsibility:

• Lead, plan, and supervise all IPC Quality operations across all GMP areas within the manufacturing site.
• Define and establish sampling and control procedures in production processes, facilities, critical systems, and equipment.
• Propose and apply sampling and/or control procedures and enhance their continuous improvement according to current regulations.
• Ensure the suitability of the collected samples so that they are representative of the quality of the product, equipment, or facility.
• Lead, organize, and plan tasks and human resources to ensure the proper execution of work procedures in accordance with production activity planning.
• Propose the acquisition of materials or equipment for the development and improvement of control procedures, as well as supervising their proper maintenance.
• Ensure accurate, complete, and timely IPC records, reviews, and approvals in support of batch release processes.
• Oversee daily IPC shop floor presence, ensuring effective GMP oversight in clean areas and correct execution of sampling and IPC checks.
• Manage and develop IPC team members, ensuring competency, compliance, and readiness through structured training and coaching.
• Approve the results of the controls carried out while respecting the established deadlines.
• Report the results and deviations obtained in the sampling and control procedures according to the established planning.
• Conduct investigations related to detected deviations and propose or advise on corrective/preventive actions to be taken.
• Attend evaluation committees related to their functions and propose or recommend improvement actions for the identified issues.
• Supervise the traceability of the documentation generated in production procedures, ensuring compliance with established deadlines.
• Lead trend analysis of IPC results and process performance, identifying deviations, patterns, or areas needing corrective actions.
• Present the sampling and control procedures applied to facilities and equipment to regulatory agencies or audits as required.
• Provide the necessary information regarding their activities to official agencies or audits upon request.
• Prepare the necessary documentation to demonstrate the proper condition of equipment and facilities through obtained results.
• Prepare the necessary technical reports to support compliance with current regulations.
• Advise on the design, implementation, or modifications of facilities or equipment to ensure compliance with current GMP regulations.
• Advise other departments on the required quality levels based on the purpose of the facility or equipment.
• Propose control frequencies and procedures compatible with production processes in collaboration with other departments.
• Prepare and supervise work procedures affected by modifications or changes in facilities, systems, or equipment.
• Ensure alignment of IPC quality practices with corporate standards, quality policies, and global quality directives.
• Collaborate closely with the Manufacturing Quality Systems team to harmonize IPC procedures, ensure alignment with site-wide quality processes, drive consistency in
• documentation ,and support continuous improvement of the integrated quality system.

Academic & Professional experience required:

• Bachelor‘s Degree in Health-related Sciences ,Pharmacist preferably.
• Knowledge of cGMP requirements and aseptic processing, in-process Quality control, and IPC sampling and testing.
• Minimum 5–7 years of experience in GMP pharmaceutical manufacturing, aseptic operations, or QA IPC roles.
• Computer proficiency, MS Office knowledge.
• Experience with eQMS and ERP systems (SAP, Veeva Vault, DCM, etc.)
• Advanced writtenand spoken Englishand Arabic.