Emad Talaat Shenouda

Quality Assurance Section HeadFull Time

• Job Details:My responsibilities had initially focused on the start-up of the project and all quality requirements to enable approval of the facility by the local regulatory authority (Ministry of Health at the time) and subsequent start of production and distribution. Responsibilities include leading the QA staff to establish the QA systems and run the QA functions in efficient and timely manner. Handling external audits from Tollers/licensors and local authority (EDA), developing action plans for the audit observations and following-up their proper and in-time closure. Involvement with the different stakeholders in preparation of CAPAs in response to Deviations, nonconformities, internal and external audit observations, etc. in addition, follow-up of CAPA to ensure timely and proper closure. Revision of Quality Agreements between the company and other licensors and tollers. Involvement in technology transfer and revision of Technology Transfer Protocols between GAP and an international pharmaceutical company (for which GAP is one of its TPMs). Review of GMP documentation ensuring they are well written, technically sound, and complying with regulatory expectations. Coordination and document review of qualification activities such as Equipment Qualification, HVAC Qualification, Cleaning Validation, Aseptic Process Validation (Media-Fill), Purified Water and WFI systems Qualification, etc. Preparation of Internal Audit plan and involvement in internal audit execution. Management of the CAPA system, Change Control System, and Deviation System Overview and revision of the Supplier Qualification process. Management of the Risk Management Process, including Risk Assessment studies that should be submitted to EDA to approve manufacturing of hazardous products. Dealing with regulatory inspectors during routine visits and inspections on the site. Overview and revision of Media-fills, Cleaning Validation, and Process Validation, Thermal Validation of Autoclaves, and SIP of machines.

Validation Unit HeadFull Time

• Job Details:• Working as Validation Unit Head at Minapharm pharmaceuticals. • Responsibilities include: management of process validation activities, preparation of process validation protocols, full supervision of manufacturing of validation batches, reporting of validation studies, and statistical evaluation of the process performance. • Management of Cleaning validation activities, preparation of cleaning validation documentation, and sampling. • Responsible for the quality and the validated status of the computerized system of the company i.e. assessment of changes and consequent need for additional testing, follow-up and closing of CAPAs raised in response to internal and external audits, etc. • Attendance of area qualification tests. • Planning of media fills activities and subsequent reporting. • An instructor at the operational excellence/six sigma training program. • A member in the supplier evaluation program. • Delivering training on the use of statistical tools and software. • Attendance of many GMP training sessions in the following subjects: Sterile production, HVAC system, area qualification, risk assessment, sterilization.