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  • Posted: Jan 23, 2025
    Deadline: Not specified
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    Fresenius is a globally active health care group providing products and services for dialysis, hospitals and the medical care of patients at home. In addition, Fresenius focuses on clinic operations as well as on engineering and services for hospitals and other health care facilities. Why work for Fresenius? You spend a significant part of your life in the w...
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    IT Technician

    General Duties:

    • Diagnose, repair, and maintain hardware and software systems.
    • Provide support across multiple platforms, including Windows, Linux, macOS, Android, and iOS.
    • Troubleshoot technical issues, network problems, and application errors.
    • Install and configure hardware (laptops, desktops, printers, peripherals) and software solutions.
    • Support and troubleshoot video conferencing and onsite events.
    • Ensure operational efficiency in server rooms and enterprise networks.
    • Support the Production of MIT systems.
    • Active Directory, O365, SAP, SCCM, Intune.
    • ServiceNow Helpdesk Support.
    • Backup and restore.

    Customer and Technical Support:

    • Offer timely resolutions for IT-related issues via phone, email, or in-person support.
    • Document troubleshooting procedures and create user-friendly guides.
    • Maintain hardware inventories and support the roll-out of new applications.
    • Provide periodic feedback and follow-ups with users to ensure satisfaction.
    • Support Global IT Helpdesk (Levels 2 and 3)

    Project Coordination and Administration:

    • Coordinate IT projects within set budgets and timelines, in consultation with the IT Manager.
    • Document IT SOPs, WI, software licenses, and procedural updates.
    • Ensure compliance with company standards and operational requirements.

    Requirements

    • Degree/Diploma in Information Technology.
    • 2-3 years of IT support experience, ideally in pharmaceutical or FMCG environments.
    • Proficiency in Windows Server (2008-2019), Windows 10\11, Microsoft Office 365, VPN’s, Polycom systems. Good understanding of MIT systems.
    • Experience in VMWare, Azure, and Veeam.

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    Sterility Support & Validation Manager

    General Duties

    Validation Section Management

    • General Section Management, i.e., Activity planning, co-ordination, execution and control (Project Management)
    • Maintenance of department efficiency through principles of supervision and management.
    • Acting as communication link between staff members and other departments and Management
    • Management and oversight of technology transfer activities (e.g., a commission of a new product and design element responsibility).

    Systems maintenance

    • Such that FKMSA is able to satisfy regulatory authorities and Inspection bodies of necessary validation measures for continued business and securement of new business.

    Validation

    • Responsible for implementation of a Risk Based Approach to all Validation and Qualification activities.
    • Ensure that all Validation and Qualification activities are managed and carried out according to GMP requirements.
    • Prepare and manage the Validation Master Plan which includes all equipment and process validation, utilities, computers and other related areas.
    • Overall responsibility for the development, preparation and implementation of written procedures, URS, DQ, IQ, OQ, PC, protocols and reports relating to Validation, Qualification and Calibration, inclusive of production, warehouse and laboratories.
    • Liaison with QA and Regulatory Affairs Department regarding process /validation requirements and the co-ordination thereof.
    • Ensure all Validation activities are managed and carried out according to GMP requirements
    • Present and justify validation scope and documents to both internal and external auditors

    System evaluation

    • General process evaluation.  This includes reporting of observed deficiencies to the correct persons and follow – up on corrective action liaising with Production where necessary.
    • Monitoring and auditing compliance to both regulatory requirements and in-house standards regarding current Good Manufacturing Practices.
    • Shared responsibility for the investigation into and solution of process and quality problems as well as preventative planning and action.
    • Carry out other tasks within the department/ factory which are consistent with the grade, qualification and training of the incumbent.

    Quality

    • Responsible to conduct investigations and root cause analysis through Kabitrack

    Budget and Cost Control

    • Control and optimise the cost within the department
    • Set quality and performance KPI’s for the department and monitor the departmental performance on a defined frequency
    • Continuously improve processes to introduce World Class Manufacturing practices within the business
    • Identify opportunities for productivity and efficiency improvements

    Human Resources Management

    • Manage all personnel in the department including disciplinary procedures
    • Ensure that all personnel in the department is developed and trained as required by the various job functions
    • Recruitment of staff
    • Staff development regarding identifying needs and opportunities
    • Performance Management evaluation
    • Review salaries and promotions if applicable
    • Implementation of equity plan as set out in the Employment Equity Policy

    Requirements

    • A Life Science or Engineering degree or equivalent. 
    • 5-10 years of direct Validation Management experience in the pharmaceutical industry.
    • Project Management skills
    • Understanding and network in Regulatory Authorities and Inspections
    • Risk assessment and evaluation methodology
    • Good Manufacturing Practice Regulations
    • Procedures and Documentation
    • Audit experience, initiating, performing and following up
    • Financial skills to control and optimize costs
    • Continuous improvement methods
    • Validation & Qualification requirements

    Method of Application

    Use the link(s) below to apply on company website.

     

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