Hikma Pharmaceuticals

Project Manager

• Regular and predictable onsite attendance and punctuality.
• Direct the implementation of capital projects through employees, temporary personnel and contractors.
• Monitor costs and schedules of delegated projects.
• Control costs and schedules of assigned projects.
• Facilitate the development of complex project scopes, cost estimates and schedules in conjunction with requesting departments.
• Provide engineered solutions for issues arising during project scope development.
• Accountable towards the implementation of projects in conformance with plant standards for equipment, piping, instrumentation and automation, and plant drawings by leveraging talents of engineer and support personnel.
• Provide technical support and resources to other site departments, as required.
• Ensure that employees and temporary personnel assigned to projects have a thorough understanding of the design basis of assigned systems in order to provide technical support to the projects and are trained adequately to perform tasks efficiently and safely in accordance with engineering related Departmental Procedures (i.e., Project Engineering Guidelines and Practices).
• Ensure that all work activities are completed in accordance with company and governmental safety, environmental and health rules, codes and guidelines. Ensure same for employees, temporary personnel and contractors assigned to projects.
• Complete all required tasks for project close-out and documentation, including project archiving, financial close, O&M manual transmission to Maintenance, and related system training.
• Maintain engagement with existing plant operations and organization to remain aware of current business needs, and standards of design and operation in the plant.
• Collaborate with peers and functional Management Team in establishing key supplier relationships, oversight and governance and take a lead role in negotiating value with key suppliers and assisting in clearly defining services required.
• Establish and monitor procedures and controls to ensure supplier interactions are value adding, appropriate and ethical, meeting all corporate guidelines and legal requirements.
• Assess internal and external resource requirements to optimize for successful implementation of projects.
• Use external resources when appropriate to supplement internal resources to deliver outputs and investments per the agreed timing and scope at the optimal Total Cost of Ownership.

Manager, Project Executive

Analyst

• Eseguire analisi chimico‑fisiche su acque di processo (PW, WFI, vapore), aria compressa, materie prime, campioni in-process e prodotti finiti secondo procedure interne o compendiali.
• Eseguire analisi per studi di stabilità seguendo protocolli e tempistiche stabilite.
• Condurre attività di analytical transfer, verifiche e validazioni analitiche secondo protocolli approvati.
• Applicare tecniche analitiche strumentali quali pH‑metria, titolazioni Karl Fischer, UV‑Vis, FT‑IR, polarimetria, conducimetria, TOC, conta particellare sub‑visibile, oltre alle principali tecniche di chimica tradizionale.
• Gestire reagentistica, standard, materiali di consumo e spedizione dei campioni, supportando le attività quotidiane del laboratorio.
• Registrare tutte le attività e i risultati secondo le norme cGMP, garantendo compliance a SOP, metodi e specifiche approvate.
• Garantire la corretta manutenzione e qualificazione delle apparecchiature prima dell’esecuzione delle analisi.
• Contribuire alla preparazione e revisione di SOP, metodi analitici, protocolli e documentazione tecnica.
• Operare nel rispetto delle politiche di sicurezza, qualità e ambiente.

Analyst, QC

General

• Monitor and identify relevant tender opportunities.
• Review tender requirements and assess eligibility criteria.
• Prepare and submit tender documentation within established deadlines.
• Coordinate with Sales, Finance, Supply Chain, Regulatory Affairs, and other stakeholders.
• Support the preparation of pricing proposals and commercial offers.
• Ensure the accuracy, completeness, and compliance of tender submissions.
• Follow up on tender awards, contract execution, and customer requirements.
• Maintain tender databases and prepare periodic activity reports.

Specialist, Tenders

Associate

• To conduct scientific studies and experiments to develop new products and technologies and improve existing ones.
• Implements all analytical research activities including initiation, designs, routine procedures, and reports on any faced issues to support product development efficiently.
• Conducts the development activities for basic pharmaceutical formulations including initiation and reporting any faced obstacles to support product development in a timely manner with considerations for scale-up/ tech-transfer.
• Demonstrates excellent oral and written communication skills with the ability to present results through written reports, publications, and related documentation.
• Summarizes and critically evaluates the study results in order to develop and test new hypotheses, execute experiments and author technical reports.
• Participates in the development and scale-up processes from bench top to pilot scale to assist in technology transfer to commercial plants.
• Establishes a knowledge base by actively seeking out technologies and tracking publications in relevant fields to keep the company informed of research and industry developments.
• Gathers and provides new perspectives, arriving at solutions based on multiples sources of information to evaluate and solve complex technical challenges that arise on both internal and external projects.
• Analyses and evaluates test results to make well-reasoned strategic recommendations that inform future R&D decisions at the company.
• Collaborates and gains commitment with stakeholders internally and externally to achieve project objectives in support of product development and approval.
• Contributes to the identification of opportunities for continuous improvement of processes and practices considering ‘international best practice’, improvement of business processes, cost reduction and productivity improvement.
• Complies with all relevant safety, quality and environmental management policies, procedures, and controls to ensure a healthy and safe work environment.
• Performs other related duties or assignments as directed.

Senior Associate Scientist, Formulation Development

QA Engineer

• Handle and approve deviations, investigations, and laboratory investigations
• Ensure product compliance with specifications and cGMP requirements
• Approve validation protocols/reports, process validation, stability protocols, APRs, and master batch records
• Review and approve change controls
• Perform risk assessments and review gap analysis reports
• Conduct QA rounds, and in-process checks, documentation reviews, ensuring completeness and compliance
• Create, update, and review SOPs, including periodic review cycles
• Prepare and review CAPA and quarterly reports, ensuring effectiveness tracking
• Issue and follow up on Quality Circles
• Performs line clearance and area verification
• Monitors GMP compliance on the shop floor
• Reviews and approves batch manufacturing records (BMRs)
• Reviews equipment logs, cleaning logs, yield calculations
• Verifies sampling, dispensing, packaging activities
• Issues and receives labels, controlled documents

Senior Officer, QA

Program Officer

• Ensuring that all required preparations for the shipping process are in place.
• Communicating with the warehouse function in order to inform them with the daily required shipments to take the necessary actions accordingly.
• Completing all paperwork and issuance of invoices in a timely manner to facilitate the shipping process.
• Updating the SAP System with the related Shipping function transactions in a daily manner to ensure alignment between the Shipping function and all JPI-concerned functions.
• Documenting, filing, and maintaining all shipping function papers and documents such as shipping companies’ schedules, invoices, Air Way Bills (AWB’s) and shipping orders.
• Following up with shipping companies on shipping schedules and status.

Shipping Officer – Tamheer Program

• Prepare the production line
• Perform routine tasks related to cleaning the production line
• Operate machinery
• Carry out tasks associated with the role in accordance with internal and external standards
• Conduct environmental monitoring in the production area.

Lyophilized Production Technician

• Responsible for managing shift or multiple shift operations within manufacturing departments.
• Responsible for meeting budget, quality, and production goals, setting standards, and making employment and staffing decisions.
• Interprets manufacturing policies, procedures, and programs
• Supports the parenteral pharmaceutical manufacturing facility through the qualification and/or validation of equipment, raw materials, and manufacturing processes.
• Validation activities include research, protocol writing/execution and final report generation.
• Conducts investigations of manufacturing challenges and process improvements evaluation/implementation.
• Final documents are archived and may be included in or support A/NDA submissions and made available as needed during FDA, MHRA, and client/customer compliance audits.

Associate Scientist

Supervisor

• Responsible for meeting production requirements, delivering quality products to customers in a timely fashion and cost-efficient manner.
• Identify/prioritize/provide resources to assist the department manager to meet the annual operating plan and budgetary commitments.
• Supervise the daily manufacturing operations across a department or multiple departments.
• Emphasize training and implement control systems on the shift or multiple shifts to eliminate product discrepancies.
• Commit to employee feedback and developmental processes.
• Provide a positive and equitable working environment emphasizing Respect/Responsiveness/Results.
• Support and emphasize the Safety and Quality commitments of the department.
• Make staffing decisions.
• Investigate and resolve disciplinary issues up to and including suspensions and terminations.
• Responsible for driving operational excellence and flawless execution in the areas of cost reduction, discard reduction, annual productivity improvements, inventory turnover, regulatory excellence including exception reduction and internal/external regulatory commitment management, on time delivery and lead time reduction, improving the overall safety of the work environment, leadership development and the ability to create a Lean Manufacturing, total employee involvement workplace.

Process Supervisor – 2nd Shift

Medical Director

• Lead the North American (U.S. and Canada) Medical Affairs strategy across all therapeutic areas and product classes, including medical vision, strategic objectives, evidence-generation portfolio, key opinion leader engagement, and resource plan
• Support the positioning of Medical Affairs as a strategic pillar on par with R&D and Commercial in shaping product strategy and the external scientific narrative
• Set Medical Affairs priorities based on scientific need and stakeholder impact
• Own the North American (U.S. and Canada) Medical Affairs workforce strategy across Hikma FTEs and contracted agency personnel, including MSLs, medical writers, and medical information specialists
• Manage build-vs-partner decisions, including current in-house MSL coverage and upcoming launch-program MSL build
• Own and oversee onboarding, certification, and annual recertification for all Medical Affairs personnel (FTEs and contractors).
• Establish and maintain strong relationships with key opinion leaders, healthcare professionals, and other relevant stakeholders in the U.S. and Canadian markets
• Own publication strategy, scientific platforms, congress strategy, and authorship governance across the portfolio

Director – North America Medical Affairs

Technician

• Monitoring and maintaining all production equipment on the production floor.
• Responsible of mechanical maintenance requirements for high-speed filling, packaging, equipment component prep and compounding.
• Perform troubleshooting of high-performance production equipment and evaluate critical spare parts.
• Maintain equipment logs, and documentation according with SOP, cGMP and all updated guidelines.
• Completes necessary corrective and preventive work orders, as well as assigned trainings, OEM and outside contractors.
• Performs all set-ups and change overs and/or repairs of equipment as necessary per production needs and schedules.
• Work closely collaboratively with Operations and engineering organization / personnel to meet all production objectives and site goals/KPIs.

Mechanical Technician

Engineer

• Supervise the operation, monitoring, and maintenance of utilities systems including HVAC, water treatment, compressed air, and Building Management System (BMS)
• Monitor BMS alarms, trends, and system performance
• Analyze utilities performance data and BMS reports for improvements
• Coordinate with service providers for troubleshooting and upgrades
• Follow up and verify completion of maintenance activities
• Conduct daily inspections and reviews for compliance
• Participate in root cause analysis investigations and implement actions
• Prepare utilities performance and energy consumption reports

Senior Engineer, Projects & Facilities

Financial Planning and Analysis

• Responsibility of (1) monthly-closing tasks
• General ledger journal entries
• Account reconciliations
• Assist in preparation of the monthly financial reporting package and supplemental schedules for reporting to Corporate
• Assist in financial planning and budgeting
• Collaborate with business partners for purposes of analysing income statement fluctuations
• Ownership of maintaining and enhancing Hikma’s documentation of internal processes and controls
• Help and coordinate requests with internal and external auditors
• Maintain a questioning mindset to analytically review and challenge the accuracy of support for journal entries and account balances.
• Reviews accounting policies and procedures and, as needed, recommends process improvements.

Finance Specialist

Team Leader

• Executa as tarefas da função em estrita conformidade com os Procedimentos Operacionais Normalizados (SOPs)
• As Boas Práticas de Fabrico da empresa (cGMPs) e os requisitos da Food and Drug Administration (FDA)
• Responsável pela formação de novos colaboradores e pela respetiva documentação
• Realiza a limpeza/libertação da linha (line clearance)
• Garante que não permanecem produtos ou componentes estranhos na linha
• Efetua configurações (setup), resolução de avarias (troubleshooting) e mudanças de formato (changeover) em máquinas de inspeção e/ou outros tipos de equipamentos de inspeção
• Realiza a verificação de sistemas eletrónicos/de visão, mecanismos de codificação e/ou equipamentos
• Efetua todos os movimentos necessários no sistema X3 para o registo do lote
• Incluindo declarações de produto e devoluções
• Revê os livros de registo (logbooks) e a documentação gerada nas áreas de inspeção e embalagem a granel (bulk packaging)

Team Leader, Inspection

Compliance

• Providing support and guidance to the Hikma injectable sites including compounding by: Lead auditing coordination, approach, and execution for injectables/Oral/ laboratory/Data Integrity manufacturing/contract manufacturing CMOs
• Ensuring internal injectable/Oral Hikma site compliance with Hikma’s rules and policies through internal audits
• Following up on all observations by Hikma and third parties which includes CAPA plan implementation and ensuring timely completion.
• Providing concerned Hikma employees with the required guidance related to the injectables/Oral/laboratory/Data Integrity manufacturing/contract manufacturing CMOs manufacturing processes to ensure that the related international standards and specifications are applied on all Hikma concerned processes
• Investigating and studying different problems related to injectables/Oral/ laboratory/Data Integrity manufacturing/contract manufacturing CMOs manufacturing processes that might occur in all Hikma concerned functions and recommending the corrective actions accordingly
• Ensuring that health and safety regulations are followed in the concerned processes to avoid accidents in the workplace during executed audits protecting the auditors