• Ensure manufactured products are in compliance with cGMP, regulatory and business requirements.• Create, Assess, Review or Approves GMP related documents such as SOPs, CCRs, Deviation, Test methods, Validation & Qualification protocols and reports.• Cooperate with Regulatory, Sales and Supply Chain departments to identify issues that could affect product quality.• Performs regulatory document reviews and prepare regulatory or other required documents as per local and international… Show more • Ensure manufactured products are in compliance with cGMP, regulatory and business requirements.• Create, Assess, Review or Approves GMP related documents such as SOPs, CCRs, Deviation, Test methods, Validation & Qualification protocols and reports.• Cooperate with Regulatory, Sales and Supply Chain departments to identify issues that could affect product quality.• Performs regulatory document reviews and prepare regulatory or other required documents as per local and international guidance.• Review batch and quality documentations & assess whether product is fit for release.• Performs, reviews and approvals of new project-related documentation such as (user requirement specification, installation, operational and performance qualification.• Serve as QA representative to cross functional project teams such as internal and external audit, suppliers qualification, process validation, and process improvement. Show less

Quality assurance Pharmacist at human insulin facility.Provide technical investigation support in review of deviations and investigationsto assess cGMP , FDA , WHO and local MOH regulations compliance.Review and release batch records.Review the applicable sections of regulatory submissions.Manage quality functions through ERP system.Create, review or approve controlled cGMP documents including SOPs, material specifications,investigation… Show more Quality assurance Pharmacist at human insulin facility.Provide technical investigation support in review of deviations and investigationsto assess cGMP , FDA , WHO and local MOH regulations compliance.Review and release batch records.Review the applicable sections of regulatory submissions.Manage quality functions through ERP system.Create, review or approve controlled cGMP documents including SOPs, material specifications,investigation protocols/reports, process validation or qualification protocols/reports as applicable.Serve as QA representative to cross functional project teams such asinternal and external audit, suppliers qualifications, process validation, and processimprovements.Review/Approve technical change controls. Show less

Solid dosage form production pharmacist at processing of:TabletCapsuleSachetsPowder of human productsPowder of veterinary productsSupervise activities and personnel that engage with manufacturing process as:Wet and Dry granulationCompressionCoatingPackaging process ( filling, blistering , automatic and manual packaging) .Maintains a compliance with cGMP and relevant regulations within production processes.Maintains a compliance with… Show more Solid dosage form production pharmacist at processing of:TabletCapsuleSachetsPowder of human productsPowder of veterinary productsSupervise activities and personnel that engage with manufacturing process as:Wet and Dry granulationCompressionCoatingPackaging process ( filling, blistering , automatic and manual packaging) .Maintains a compliance with cGMP and relevant regulations within production processes.Maintains a compliance with quality management systems (ISO 9001 2008/2015) Show less

Sterile production pharmacist in majority of sterile products such as: Ampoules, Eye drops and powder, solution, pre filled styrene and lyophilized Vials. Main responsibilities :- Fulfills the monthly and weekly production plans. - Controls production and packaging process and facilities.- Preparation of bulk solution of all sterile products.- Monitors manufacturing activities in compliance with the requirements of cGMP and company management system .- Ensures… Show more Sterile production pharmacist in majority of sterile products such as: Ampoules, Eye drops and powder, solution, pre filled styrene and lyophilized Vials. Main responsibilities :- Fulfills the monthly and weekly production plans. - Controls production and packaging process and facilities.- Preparation of bulk solution of all sterile products.- Monitors manufacturing activities in compliance with the requirements of cGMP and company management system .- Ensures the general cleanliness and hygienic conditions of the manufacturing areas.- Checks the availability of adequate raw and packing materials, utilities, filters and machine.- Supervises employees engage in manufacturing and packaging process and dispenses batches according to BMRs.- Makes sure the on job training of production and packaging personnel.- Ensures that there is discipline and good working culture among the staff.- Handle and write reports about: Reconciliation of production and packaging process , KPI,OEE,CAPA, deviation report, process flow chart, organization structure, change control report, SOP and batch manufacturing record.- Participate with R&D and validation team in transformation of products from small scale to large production scale (technology transfer) . - Perform other related duties as required by the nature of the work. Show less