Hany Kamel Email & Phone Number

Egypt

Established, maintained, and enhanced the EU GMP-certified quality management system. Led SOP review and changes, investigated deviations and complaints, and executed effective corrective/preventive actions. Managed recalls, self-inspections, and audits, ensuring GxP compliance. Developed training plans, conducted QM reviews, and ensured adherence to international standards. Oversaw data collection, statistical reporting, and QA strategies. Directed corrective actions, managed teams, and addressed non-conformance trends for sustained quality excellence.

Al-Salyhia El Gedida, Sharkia, Egypt

6 October City

Reporting directly to the CEO, led QMS harmonization and ensured compliance and enhancement of Quality & EHS System. Managed change control, risk assessment, and ISO certifications, including equipment and computer systems validation. Provided ERP implementation expertise and conducted validation projects for third-party clients. Monitored cGMP compliance, investigations, CAPA, and training. Escalated compliance issues, authored reports, hosted regulatory audits, and managed supplier audits. Handled product complaints, budgeting, and served as Management Representative, ensuring adherence to standards, effective issue resolution, and continuous improvement.

Al Obour City Egypt

Reporting to the CEO, directed QMS harmonization, ensured compliance, and drove continuous improvement of Quality & EHS System. Owned site validation plan, led ISO preparations, and validated equipment/computer systems. Provided ERP expertise, managed third-party validation projects, and oversaw cGMP compliance. Approved investigations/CAPA, monitored effectiveness, and coordinated CGMP & EHS training. Escalated compliance issues, authored reports, and hosted audits. Enabled timely issue resolution, prepared Quality & EHS Review reports, and audited suppliers. Integral in regulatory and customer audits. Overall, led holistic quality management, compliance, and improvement, ensuring product quality and alignment with standards

Sulaymania Iraq

Reporting to the General Manager and indirectly to the board, a key member of the management team responsible for business growth. Lead ERP deployment and EU certification projects. Trainer in CGMP and Pharma QA trends for the team, driving compliance with Eudralex, ICH, WHO, and FDA. Oversee audits of API, materials, contractors, and facilities. Contribute to product and facility expansion projects. Instruct on PIONEER quality system for visitors, manage retrospective, concurrent, and prospective qualification/validation efforts. Drive upgrade of packing lines with barcode readers, inspection cameras, and control devices. Integral role in quality, compliance, and technological advancements.

October City

Supervise and support QA staff in daily tasks including Periodic Product Review and Validation. Coordinate product documentation preparation and revisions. Establish standardized QA practices across areas. Lead internal audits and manage actions, representing the company in external audits and risk-based quality audits. Maintain facility-related documents, aligning local docs with guidelines. Report Quality KPIs and manage deviations, incidents, and complaints. Propose improvements, prioritize critical issues, and ensure corrective/preventive actions. Oversee validation-related quality activities and exceptions. Execute various quality tasks while driving effective communication and prioritization.

6 October City

Participate in GMP and Validation projects, oversee site validation review plans, and ensure compliance with regulatory guidelines. Prepare Validation Master Plans, Performance Qualification Protocols, and Validation reports for various activities. Manage calibration activities, validation deliverables filing, and Analytical Method Transfer completion. Follow up on change control implementation, safeguarding quality and regulatory compliance. Ensure changes are effectively assessed and managed, aligning with regulatory standards (ISO, EU, WHO, ICH, FDA) and product master file. Maintain health, safety, and efficacy standards, driving traceability and intended results while contributing to business benefits.

Cairo Egypt

Lead internal and external quality audits for Cairo-Site GMS (Global Manufacturing and Supply) in accordance with GSK QMS requirements. Manage the level two site quality audit program, including scheduling, scoping, and coordination. Conduct audit preparation, lead meetings, document observations, and facilitate formal discussions. Report findings to auditees and provide an executive summary to Site Director, Quality Head, and Director of Quality MENA/SSA. Evaluate audit responses, engage with auditees on actions, and compile comprehensive reports with corrective/preventive actions and responsible parties. Maintain the GMS Cairo-Site Unified CAPA's database for tracking progress.

10Th Of Ramdan City

Prepare quarterly self-audit reports detailing GMP deviations, propose solutions through action plans, and set compliance target dates. Report non-compliance incidents and oversee preventive/corrective actions. Investigate customer complaints, recommend preventive measures. Assess annual quality performance through QA annual report review, providing suggestions for product quality enhancement. Key involvement as QA representative in new line upgrades and active participation in new product and process validation.