Consultant, Policy and Compliance Monitoring
UNRWA
Total des années d'expérience :22 years, 7 Mois
Contributes to the development of the Agency's standard policies, operating procedures, manuals, instructions, guidelines related to procurement, supply chain, fleet management and general administration services to obtain Best Value for Money for the Organization.
Contributes to the development of methodologies/tools/documentation to ensure standardization and streamlining of procedures to gain into efficiencies and best serve internal clients, while maintaining strict adherence to financial rules and regulations
Monitors accuracy of data available in information systems (ERP, e-tendering tool, UNGM, Fleet wave, Fleetlog, etc.). Reports any issues on information systems integrity and confidentiality of sensitive information and proposes corrective plans as necessary to make sure data are accurate and updated. Reviews and updates UNSPSC codes, material list of vehicles and spare parts, Business Partners profiles, etc. Reviews requests for access to information systems;
Prepares critical statistical reports Agency-wide for activities related to procurement, supply chain, fleet management and general administration services. Provides guidance to staff in Headquarters and Field Offices to search and retrieve statistical data from information systems. Prepares research, analysis, reports, and surveys as transversal support to other sections to facilitate strategic decisions to be taken;
Provides support to undertake internal reviews and assistance visits; identifies abnormalities and areas of risk. Conducts analysis, identifies trends, proposes and monitors performance indicators;
Participates in the production of training programs in the area of procurement, supply chain, fleet management; analyses results and identifies skill gaps and training needs including best practices. Provides support to establish generic or specific terms of reference and evaluation criteria;
Provides support to coordinate and review the responses to audit reports and addresses any alleged violations of the Agency's financial rules, regulations and policies in the field of procurement, supply chain, fleet management and general administration services. Monitors implementation of mitigation measures pursuant to auditors' observations;
Performs other duties as may be assigned by the supervisor(s).
Manages day-to-day operations of multidisciplinary projects to ensure performance within the agreed timelines, budget and according to the required specifications
Supervises and monitors performance of Pharmaceutical Development team members and lead the projects
Coordinates and manages the activities within the Manufacturing and Quality Department to manage production schedules ensuring the highest quality standards, and safety issues
Communicate with all relevant inter-company contacts: provide adequate information, consult the appropriate persons in case of problems and contribute to the decision making process
Supervise Quality Control and Quality Assurance departments to ensure GMP and GLP compliance to all products.
Set up, manage and keep up-to-date the Production Files in accordance with the company SOPs and cGMP in such a way that any relevant information can be presented promptly during internal or external audits
Work with manufacturing and product development to solve difficult technical problems and coach manufacturing personnel in solving technical problems. Design and implement management controls for improving manufacturing processes.
Organize and provide training for employees on procedures and equipment relevant to manufacturing, GMPs/cGMPs, GLP and validation.
Manage and improve regulatory processes, ensuring efficient, accurate and timely delivery of technical documentation to all health authorities worldwide.
Partnering with the regulatory affairs in implementation of the Regulatory strategy for products in development and/or commercialized products.
Serves as a technical representative of the company
1) The overall monitoring of the implementation and reporting of program and project-related activities in the Health Program Department at the Jordan Field.
2) Support Jordan Field Office in the development and application of systems of monitoring and evaluating of program and project-related activities.
3) Develop project proposals for presentation to donors.
4) Prepare project narrative and financial report for donors.
5) Briefing and position papers for management, counterparts, partners and donors.
6) Follow up on progress and issues regarding procurement, finance and construction with relevant departments.
7) Develop and maintain productive working relationship with management, donor, partners, beneficiaries, and other stakeholders.
8) Maintains and provide up-to-date information on projects and program activities in the field.
9) Assist the Health Program to institutionalize Project Cycle Management Procedures.
10) Follow up all financial transactions on SAP starting from budget breakdown, mapping, budget follow up, expenditure monitoring and project closing.
11) Management and monitoring of procurement process related to projects including: assessment of needs of health program per each project, conducting market research, estimating required budget breakdown, raising purchasing requisition on SAP, follow up tendering process with procurement department, participating in technical and financial evaluation, follow up good receipt and distribution of goods and services to end users.
Teaching Pharmacy Courses in Faculty of Pharmacy:
1- Industrial pharmacy course (theory and laboratory) (3rd year level)
2-Pharmacokinetics Laboratory (4th year level)
3- Medicinal Chemistry Laboratory (3rd year level)
4- Phytochemistry Laboratory (3rd year level)
5- Analytical Chemistry Lab (2nd year level)
6- Organic Chemistry lab (2nd year level)
7- Pharmacy training course (4th year level)
8- Drug Laws and Regulations course (4th year level)
Head of Registration & Guidance Committee: Supporting and guiding students in choosing the right courses and following their plans in registration.
1. Management of the hospital pharmacy and medical store:
• Conducting all supply chain activities of medicines, drugs, medical devices, consumables and physio-therapy equipment and items.
• Organizing the pharmacy store, classifying the products and arranging items per category according to MSF standards.
• Keeping good conditions of hygiene and conservation of the products.
• Checking the expiry dates and following procedures of waste management.
• Managing the cold chain and supervising specific storage and transport conditions.
• Counting stock and entering data in stock cards and computer to maintain inventory records
• Ensuring a physical inventory every two months
• Organizing the restocking of the pharmacy store
• Respecting MSF procedures while purchasing local medicines, medical items or medical equipment (quotations, validation)
• Updating the Approved Vendor List according to MSF regulations and patients’ needs.
• Participating in Technical Inspections visits along with Technical Inspection Team to audit, evaluate and assess Approved Vendors and approve new Vendors.
• Contacting the local suppliers and following up the orders, updating address book for suppliers and establishing a professional network with all vendors.
• Ensuring good receipt and and storing of incoming supplies
• Weekly monitoring of stock levels to avoid shortages and overstocking
2. Supplying the Ward, OPD, OT and physiotherapy with medicines, medical supplies, medical equipment and physiotherapy items
• Processing records of medication and equipment dispensed to hospital patients per each unit.
• Collecting and monitoring data related to medicines or medical supplies consumption, stock and needs and entering data in stock cards and computer
• Reviewing prescriptions issued by physicians, or other authorized prescribers to assure accuracy and determining the appropriate needs
• Maintaining medication profiles for each unit including registry and control of narcotic and controlled drugs according to Jordanian laws.
3. Reporting on pharmacy activities
• Attending weekly meeting and providing feedback on all activities
• Preparation of monthly reports of pharmacy activities
4. Budgeting and financial follow up
• Setting up budgets for all activities and products.
• Following up the consumption and expenses periodically to assure complying with budgets
• Analysis of financial issues in comparison to budgets and plans
• Monthly provision of invoices along with purchase orders to financial department
• Negotiation with suppliers to ensure procurement of best quality items with least values
5. Supporting of staff and employees
• Supervision, training, guidance and assessment of storekeepers to improve pharmacy work
• Supporting international staff and expats and improving their knowledge and awareness regarding local regulations and laws
• Provision of necessary information and support regarding medications, narcotics and medical equipment for medical and non-medical staff
Establishment of a new pharmaceutical research and development center (Contract Research Organization), including design of formulation lab, analytical lab and pilot plant, along with procurement of all necessary equipment, instruments, raw materials, chemical, reagents, supplies, etc.
Establishment of comprehensive quality and documentation systems for the company to cover all working activities.
Projects planning, execution, following up, monitoring, evaluation, assessment and reporting.
Organization, management and team building.
Development of controlled release pharmaceutical products with compliance to FDA regulations (including literature survey and patent search, preformulation studies, formulation studies, analytical development and validation, formulation development, pilot scale up, technology transfer and Exhibit batch manufacturing, following up production and process validation, bio-equivalence studies and preparation of development reports along with all related documents.
Hiring qualified staff, training and monitoring of employees.
Maintaining of team spirit and healthy working environment
Team building and management of R&D and related technical departments, besides planning, organization and development for future expansion
Management of all R&D activities and related sections including: protocol design and implementation for pharmaceutical product developments, conducting preformulation, formulation, stability studies, scale-up and production studies, products post approval follow up, development and validation of methods of analysis, process and cleaning validation.
Recruitment of R&D employees: identification of needs and preparation of job descriptions, staff selection and assessment, staff hiring and evaluation, continuous training of employees.
Writing all required documents according to GMP and international guidelines like SOPs, protocols, raw materials and intermediate products specifications, packaging materials specifications, Master formulae, Master manufacturing methods and packaging instructions.
Acting as Technical Manager and performing her duties including:
- Supporting, guidance and acting as scientific reference for other departments such as: production, registration, marketing, QC and QA departments.
- Collaboration with other departments to improve the quality of products and ensure compliance to GMP in order to obtain GMP certificates in different countries such as Europe and GCC.
- Ensuring GMP/ GLP implementation and adherence to up-date to guidance inside the company
- Management, conducting and evaluation of Investigation of Out of Specifications protocols and reports, ensuring proper corrective and preventive actions (CAPA)
- Monitoring and assessment of bioequivalence studies
- Conducting statistical analysis and preparation of final reports
- Preparation of common technical documents required for registration according to ICH requirements.
- Follow up all requirements for registration and post-registration for various countries.
- Follow up and qualification of suppliers of raw materials and packaging materials and choosing most suitable ones with optimum quality
- Management and conducting all validation activities related to technical department including: design qualification, installation qualification, operation qualification, performance qualification and process validation
- Collaboration with other technical and quality departments for trouble-shooting and problems solving
- Ensuring continuous development inside the company
Development and formulation of solid dosage forms
Conducting preformulation studies.
Performing all formulation and scale up studies
Analysis of raw materials, intermediate products, in-process control and finished products.
Conducting stability programs and studies according to latest international and ICH guidelines.
Designing and qualification of best manufacturing methods for pharmaceutical products, preparation of first three production batches along with process validation.
Writing standard operating procedures (SOPs), protocols, Master formulae, Master Batch Records, Master Packaging Records, Technical Documents, Reports, Leaflets, etc.
Trouble shooting for problems arising during production.
Establishing a documentation system for R&D, QC/ QA Departments
Monitoring, following up and evaluation of bioequivalence studies.
Maintenance of all R&D and QC equipment including calibration and qualification activities
Training and assessment of new staff
Double-checking technical reports and analytical sheets generated by QC analysts.
Formulation of semi-solid dosage forms (creams, gels, ointments, suppositories and shampoos), liquid preparations (suspensions, syrups), dry suspensions and sterile dosage forms (injectables, eye drops)
Conducting Literature survey and preformulation studies
Designing and qualification of best manufacturing methods for pharmaceutical products
Writing necessary documents including: standard operating procedures (SOPs), protocols, Master formulae, Master Batch Manufacturing Records, raw materials specifications, intermediate products specifications, finished products specifications, reports, etc.
Training and evaluation of new staff
Trouble shooting for problems arising during production
Following up and monitoring development of methods of analysis and stability studies
Building a new system for process validation including protocols design, writing and implementation
Preparation of registration files (CTDs) and following up all issues arising during registration of products.
Monitoring, assessment and evaluation of bioequivalence studies
Qualification of raw materials suppliers
Master degree in pharmaceutical sciences with a research project that was published inEuropean Journal of Pharmaceutics and Biopharmaceuticsas follows: Al-Sayed Sallam, Enam Khalil, Hussain Ibrahim and Ibtisam Freij, Formulation of an oral dosage form utilizing the properties of cubic liquid crystalline phases of glyceryl monooleate, European Journal of Pharmaceutics and Biopharmaceutics, 53 (2002) 343–352
