Reda Dk

Doctor of Pharmacy (PharmD) with 5+ years of experience in pharmaceutical manufacturing, Research & Development, Technology Transfer, Regulatory Affairs, and GMP-compliant operations. Experienced in formulation development, process scale-up, process validation, stability studies, batch release, and CTD dossier preparation across oral solid dosage forms, sterile injectables, and ophthalmic products. Currently serving as Assistant Technical Director Pharmacist, supporting cGMP compliance, Ministry of Health regulatory activities, international technology transfer projects, and cross-functional technical operations.

Assistant Technical Director Pharmacist (Regulatory Affairs & Tech Transfer) at Medi Pharma International (Dar Al Dawa Development & Investment Co.) (2026-06 – Present)

• Technology Transfer & Regulatory Projects: Lead, coordinate, and monitor tech transfer protocols for introducing, scaling, and industrializing new drug products from the parent company (Jordan) to the local Algerian manufacturing site.
• Operational Supervision & GMP: Oversee site-wide pharmaceutical operations (manufacturing, warehousing, pharmacovigilance) to ensure strict adherence to cGMP standards and registered marketing authorization dossiers.
• Batch Release & Inventory Control: Prepare and review all batch release documentation, oversee batch release protocols and recall procedures, and manage regulatory requirements for expired or incinerated products.
• Regulatory Affairs & Artworks: Coordinate registration and variation dossiers with regulatory teams and manage the packaging artwork lifecycle (design updates and final supplier BAT/print proof approvals).
• Leadership & Authority Interface: Serve as Acting Technical Director during absences; act as the official site representative and primary liaison with national health authorities.
• Institutional Reporting & Forecasting: Direct mandatory filings with the Ministry of Pharmaceutical Industry (weekly inventory statements, annual production schedules, and raw material/packaging import forecasts) and handle official inquiries.

Research and Development (R&D) Executive at SOPHAL SPA (2023-10 – 2026-06)

• Formulation & Development: Developed galenical formulations for oral solids (tablets, capsules, powders, granules), sterile injectables (corticosteroids), and sterile ophthalmic solutions (eye drops).
• Scale-up & Stability Testing: Conducted and supervised laboratory trial batches, formal stability studies, pilot batches, and industrial scale-up activities.
• Technology Transfer & Process Validation: Drafted tech transfer documentation and supervised industrial validation batches in close collaboration with the production department.
• Regulatory & Technical Documentation: Authored and reviewed SOPs, validation protocols, Batch Manufacturing/Packaging Records (BMR/BPR), stability reports, CTD modules, and risk assessments.
• Biowaiver Studies: Compiled biowaiver justification dossiers using WHO frameworks for bioequivalence exemption submissions.
• Raw Material Quality Control: Verified and validated Certificates of Analysis (CoA) for APIs and excipients in compliance with international pharmacopeia standards (Ph. Eur., USP, BP).
• Deviations & Investigations: Led investigations and root-cause analyses for manufacturing or pilot batch deviations, applying CAPA under cGMP guidelines.
• Equipment & Processing Operations: Operated R&D machinery (mixers, granulators, fluid bed dryers, tablet presses, coaters, capsule fillers, lyophilizers) and optimized process parameters.
• Cross-Functional Collaboration: Partnered closely with Quality Assurance, Quality Control, Production, Engineering, Warehouse, and external vendors to drive project delivery.
• Departmental Leadership: Served as Acting R&D Director for 40 days, managing team operations, regulatory compliance, and executive reporting.

Retail Pharmacist at Pharmacy Bouziane (2021-12 – 2023-10)

• Dispensed prescription medications and provided patient counseling.
• Managed inventory, procurement, and stock control.

Doctor of Pharmacy (PharmD) – University of Oran 1 – Ahmed Ben Bella (2014-09 – 2022-07)