Omar ElFar

Export SpecialistFull Time

• Job Details:1) Conduct data analytics, market screening, projections, and trend analysis in collaboration with the business development team to identify international export opportunities. 2) Build and maintain strong relationships with pharmaceutical agents, potential distributors, and out-license agents worldwide. 3) Retarget existing markets and open new markets. 4) Work closely with RA team to maintain smooth registration of eCTD/CTD in intended countries. 5) Organize and coordinate strategic meetings with stakeholders. 6) Prepare and manage comprehensive reports, including quarterly progressive reports, to track and evaluate performance. 7) Ensure accurate archiving of documents in both soft and hard copies. 8) Compare forwarders offers. 9) Participate in Tenders. 10) Review contracts. 11) Plan, execute, and participate in medical events. 12) Prepare EDA export permission, shipping documents, ensure regulatory compliance of registered products, and oversee logistics arrangements. 13) Follow up with the production/planning team to ensure export consignments are packaged properly for the intended countries with their final packing list. 14) Initiate export sales order cycle for release of consignments on JD Edward (Oracle). 15) Work closely with the quality and warehouse teams to release consignments and packed properly as well as ensure that transportation is in compliance with ICH, WHO, EU guidelines, and company SOPs. 16) Manage critical export documentation, including EDA export permission, Certificates of Analysis (COA), Certificates of Pharmaceutical Product (CPP), Bills of Lading (BOL) or AWB, and post shipment documents such as Certificate of Origin (COO). 17) Make sure that official company documents for export are authenticated from Chamber of Commerce, Pharmaceutical Manufacturing Chamber, and Ministry of Foreign Affairs.

Toll Manufacturing CoordinatorFull Time

• Job Details:1) Facilitating Overseas Operations: Assisted DXN Holdings Bhd. in establishing its business operations in Egypt by connecting DXN representatives with local Egyptian pharmaceutical companies. 2) Regulatory Affairs Support: Coordinated with outsourcing scientific teams for foreign pharmaceutical product registration in Egypt, ensuring compliance with the Ministry of Health's EDA, NFSA, and SGS standards. 3) Manufacturing and Alliance Agreements: Arranged and managed alliance agreements, including toll manufacturing and exclusive partnerships, under non-disclosure terms. 4) Materials Inventory and Logistics: Oversaw materials inventory management and logistics planning to ensure seamless operations. 5) Product Registration Process: Assisted with preparing documentation in CTD format, including detailed product information, ingredient testing data, formulation, stability studies, and biosimilarity (if applicable). Supported pilot batch studies, production planning, and logistics to meet regulatory requirements. Ensured statistical analysis and testing data adhered to Egyptian regulations for product registration. 6) Contractual and Financial Arrangements: Managed contracts covering toll manufacturing, exclusivity, intellectual property rights, breach highlights, and financial terms linked to key performance indicators (KPIs). 7) Regulatory Compliance Consulting: Worked closely with regulatory affairs professionals to navigate the Egyptian regulatory landscape and facilitate approval processes effectively.

Quality Assurance SpecialistFull Time

• Job Details:(1) QMS (Qualification) (2) GDP/GSP (Thermal & Humidity Mapping) (3) Supply Chain Anti-Counterfeit (4) Change Control (5) Internal and External Audits (6) Validation of service provider work and techniques (Installation & Process) (7) Deviation of Cold Rooms or Customized Vehicles for TTSPs (8) Mock/Product Recall (9) Customer Complaint (10) Validation Master Plan