Marwan Ibrahim Email & Phone Number

North Ras Al Khaimah, United Arab Emirates

United Arab Emirates

• Qualified person responsible for final batch release to local and export markets.• Responsible for retained sample stores management and batch record documentation control. • Leading all the OOS investigation and sharing the outcomes with MOHAP.• Responsible for deviations and customer complaints investigations. • Lead the sites QA review reporting KPIs and action plan.• Follow up and maintain the site risk log.• Quality oversight on the warehouse and quality control to ensure compliance to written procedures. • Manage and assess changes and approve action plan for implementation.• Liaise with supply chain and sales operation team for release, shipping plans and stock management.• Assess any excursion communicated by the customers during finished products shipping.• Lead the implementation of the Quality plan in 6 non sterile sites according to company's quality strategy.

Cairo Governorate, Egypt

.Supervise and approve the release of manufactured batches to both local and export markets after review of all required documentation, ensuring that batches are released after fulfilling all GMP requirements..Supervise OQ officers for application of OQ measures in production areas during routine activities and validation practices..Revise and update quality related documents, in compliance with Corporate Standards, such as GQPs, GQGs, and GQMPs. This includes batch manufacturing and packaging documents, specifications, SOPs and bills of materials..Handle investigations of deviations, complaints and OOS results, in coordination with production supervisors, Labs, Warehouse and ensures implementation of appropriate corrective and preventive actions and ensure investigation closure within specified time with intended Quality requirements..Conduct self-inspection programs, follows up implementation of required actions, and follows up implementation of actions required by other audit levels and responds to L2, L3 and L4 audits in OQ department..Report quality performance either monthly or periodically, e.g. Site KPI’s, OQ Trends (complaints, deviations … etc)..Escalate and communicate critical quality issues to local management, where necessary, and ensures that actions needed have the appropriate priority..Ensure application of OQ measures relevant to validation qualifications, change controls and exceptions handling..Accountable for training of Officers and the technical / personal development of his/her direct reports..Support GPS foundations implementation (TIPS and TAPS) and increase awareness of subordinates and make the most of using GPS tools for effective performance and on-going improvement in ways of working..Ensure that EHS policies and procedures are implemented during work and that all manufacturing and packaging processes are done according to GMS requirements.

Cairo, Egypt

.Revise Quality technical documents according to Corporate Standards, such as GQP’s, GQG’s, GQMP’s and FPG’s. This includes batch manufacturing and packaging documents, specifications, SOPs and bills of materials..Ensure proper sampling of intermediate, bulk and finished product batches for routine testing, validation practices and cleaning samples..Follow up application of OQ measures in production areas and check compliance of in-process testing..Ensure application of OQ measures during validation batches and planned changes..Monitor calibration of production equipment and IPC testing instruments..Review batch related documentation for completeness, correctness and compliance to approved standards..Report any observed incidents during routine production and follow up its correction and corrective action..Ensure that GMP Standards are followed properly in the Warehouse, Dispensing and manufacturing areas and during the manufacturing processes..Handle deviation, complaints and OOS in coordination with area owners and ensure implementation of CAPA and closure within required timeline..Team member in L1 and provide Quality inputs in CCRs..Support GPS implementation in managing different activities..Ensure identification and rejection of non-conforming materials/products according to GMP standards..Coaching operators to ensure that quality mindset is embedded in their day to day activities.

Egypt

• Setting weekly plan for managing analysis of received samples(Finished products&Stability samples, Validation samples, Raw materials sampling&analysis).• Maintain lab KPI’s (Safety, Quality, Supply.• Responsible for user checks e.g. Balances calibration (weekly&monthly)• Monitoring lab conditions and any needed instruments e.g. Refrigerator.• Quality control representative in investigations of (Deviations, OOS) and change control request(CCR) related to Lactam lab and any audits performed on Lactam lab.• Participate in method transfer project of all lactam finished products.• Participate in Specs, BAR(batch assessment record), update to comply with MOH new requirements. • Along with daily routine analysis (Finished, Stability, Validation samples and Raw materials).

Egypt

• Analyze and test bulk, finished products, stability samples and intermediates as well as finished products according to validated method of analysis and approved protocols and specifications.• Operate departmental section equipment and instruments according to approved SOP’s e.g. HPLC, GC, UV, IR and Atomic Absorption Spectrophotometer.• Implement and maintain GMP, GLP and EHS requirements daily. • Perform product validation analysis and cleaning validation analysis according to approved validation protocols.• Participate in different L1 audit runs (find gaps between SOP and guidelines, gaps between in place and in use).

Bachelor Of Pharmacy And Biotechnology, Pharmaceutical Sciences

Postgraduate Diploma, Total Quality Management (Tqm)

Activities and Societies: - Launching a Restaurant Project (Planning for top Quality), - Six Sigma improvement Project for the Chemical.