Municipiul Timişoara, Calea TORONTALULUI, KM 6, CLADIRE, BIROURI, DEPOZIT SI LABORATOR
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Define LEAN goals and implement the LEAN strategy aligned with company objectives
Ensures the training of newly hired personnel with LEAN techniques and the periodic organization of trainings for LEAN principles
Provides the team with all necessary LEAN organizational means/tools, performs 5 S audits within the laboratory
Collects, organizes, processes and uses information related to the analysis and improvement of processes in the company, ensures the management of proposals for improvement
Ensures the planning, organization and implementation of improvement projects
Ensures the identification of root cause investigation that causes quality problems using appropriate LEAN principles
Performs work standardization – creating, respecting and permanently updating work standards
Follow the process of resource efficiency, identification and elimination of waste
Supports teams in balancing the detailed programme/portfolio of improvements in order to achieve well balanced, sustainable results across the breadth of performance dimension (quality, safety, supply, cost and WIP/inventory)
Coordinate the activity for the support functions team: define, monitor and evaluate the activity of the team member
Process Ownership: Oversee LIMS Laboratory processes, Inventory Management, and Stability Management, ensuring they meet global standards and local requirements.
Lead the strategic direction, standardization, and continuous improvement in the area of expertise.
Lead the strategic direction, standardization, and continuous improvement in the area of expertise
Deputize Business Owner Activities: Support and stand in for the Business Owner as needed
Global System Implementation, Integration and Enhancement:
Advise and support business departments in analyzing, designing, and implementing business processes in LIMS and related systems.
Implement changes following defined change control procedures.
Define and implement process flows, considering local specific requirements under global requirements.
Create a master data concept in the area of expertise.
Cooperate with IT staff and external vendors to ensure seamless data exchange between LIMS and other systems
Validate data, processes and interfaces and create/update GMP-compliant lifecycle documentation.
Participate in global LIMS projects for system implementation, expansion, optimization and upgrade at different sites.
Advise and support business departments in analyzing, designing, and implementing business processes in LIMS and related systems
Implement changes following defined change control procedures
Define and implement process flows, considering local specific requirements under global requirements
Create a master data concept in the area of expertise
Cooperate with IT staff and external vendors to ensure seamless data exchange between LIMS and other systems
Validate data, processes and interfaces and create/update GMP-compliant lifecycle documentation
Participate in global LIMS projects for system implementation, expansion, optimization and upgrade at different sites
Troubleshooting and Support: Provide 3rd level support for troubleshooting LIMS-related issues in the area of expertise.
Investigate and evaluate errors, coordinate error fixing, and resolve issues in the area of expertise.
Investigate and evaluate errors, coordinate error fixing, and resolve issues in the area of expertise
Training and Documentation:
Create and maintain global training documents and SOPs in designated computerized systems.
Train LIMS key users and provide system coaching to colleagues to ensure efficient use and administration of the application.
Create and maintain global training documents and SOPs in designated computerized systems
Train LIMS key users and provide system coaching to colleagues to ensure efficient use and administration of the application
Stakeholder Collaboration: Work closely with internal and external stakeholders to ensure alignment and efficiency
Trend and Regulation Monitoring: Regularly screen new trends and regulations related to IT topics for computerized systems
Middle (2-5 ani), Fără experiență, Entry (0-2 ani)
1095 - 1215 € net / lună
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Technology Support Coordinator
Calea Torontalului, Timișoara
expirat: 23.08.2024
Middle (2-5 ani), Fără experiență, Entry (0-2 ani)
Atribuțiile:
Provide on-site technical support for IT services and assets, including computers, printers, monitors, phones, IT network, and physical access control, with partial support on industrial/lab systems
Deploy and configure end-user hardware and software, including equipment, computers, tablets, mobile phones, conferencing tools, operating systems, and Microsoft Office applications
Offer end-user support related to ICT infrastructure services, including Citrix, MFA, AD administration, mail, and Microsoft SharePoint Portal
Administer and manage IT assets, ensuring proper documentation and inventory control
Perform hardware servicing and manage third-party servicing for maintenance and repairs
Utilize and administer the ITSM ticketing tool, handling on-duty calls and providing support out of working hours for critical incidents
Support external vendors in implementing new laboratory systems and managing equipment in use
Middle (2-5 ani), Fără experiență, Entry (0-2 ani)
Salariu confidențial
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Specialist Global Quality Supplier Qualification
Calea Torontalului, Timișoara
expirat: 03.08.2024
Fără experiență, Entry (0-2 ani)
Atribuțiile:
Lead and coordinate Global GMP-related auditing and qualification processes to maintain high standards of quality and compliance across all operations
Collaborate with internal and external stakeholders to develop and maintain annual audit plans, ensuring alignment with regulatory guidelines and company standards
Manage supplier qualification records and departmental databases, ensuring accurate documentation and timely updates
Facilitate communication and correspondence with international partners, including internal teams, external auditors, and regulatory bodies
Assist in preparing comprehensive documentation for audits, including product manufacturing records, testing documentation, and audit reports
Participate in training programs and workshops to enhance team skills and knowledge in global quality assurance practices
Contribute to continuous improvement initiatives by identifying areas for enhancement in supplier qualification processes and recommending solutions for implementation
Middle (2-5 ani), Fără experiență, Entry (0-2 ani)
Atribuțiile:
Coordinate and monitor EU testing at external and internal laboratories, ensuring compliance with regulatory requirements and internal standards
Maintain close communication with internal and external production sites and affiliates to facilitate effective and timely information flow
Prepare and review comprehensive risk assessments, justify testing results, and manage changes, deviations, and Out of Specification (OOX) investigations
Collaborate with national and international production sites and contract laboratories to ensure quality and consistency in testing and production processes
Support internal departments and affiliates by providing expert guidance on analytical and GMP-related topics, ensuring adherence to best practices
Identify and implement process improvements and optimizations to enhance efficiency and quality in testing and production workflows
Middle (2-5 ani), Fără experiență, Entry (0-2 ani)
Atribuțiile:
Lead and coordinate Global GMP-related auditing and qualification processes to maintain high standards of quality and compliance across all operations
Collaborate with internal and external stakeholders to develop and maintain annual audit plans, ensuring alignment with regulatory guidelines and company standards
Manage supplier qualification records and departmental databases, ensuring accurate documentation and timely updates
Facilitate communication and correspondence with international partners, including internal teams, external auditors, and regulatory bodies
Assist in preparing comprehensive documentation for audits, including product manufacturing records, testing documentation, and audit reports
Participate in training programs and workshops to enhance team skills and knowledge in global quality assurance practices
Contribute to continuous improvement initiatives by identifying areas for enhancement in supplier qualification processes and recommending solutions for implementation
Middle (2-5 ani), Fără experiență, Entry (0-2 ani)
Salariu confidențial
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Jr Manager Regulatory Submissions Maintenance EEA
Calea Torontalului, Timișoara
expirat: 05.05.2024
Middle (2-5 ani), Fără experiență, Entry (0-2 ani)
Salariu confidențial
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Manager Global Quality Supplier Qualification
Calea Torontalului, Timișoara
expirat: 27.04.2024
Middle (2-5 ani), Fără experiență, Entry (0-2 ani)
Atribuțiile:
Lead and coordinate Global GMP-related auditing and qualification processes to maintain high standards of quality and compliance across all operations
Collaborate with internal and external stakeholders to develop and maintain annual audit plans, ensuring alignment with regulatory guidelines and company standards
Manage supplier qualification records and departmental databases, ensuring accurate documentation and timely updates
Facilitate communication and correspondence with international partners, including internal teams, external auditors, and regulatory bodies
Assist in preparing comprehensive documentation for audits, including product manufacturing records, testing documentation, and audit reports
Participate in training programs and workshops to enhance team skills and knowledge in global quality assurance practices
Contribute to continuous improvement initiatives by identifying areas for enhancement in supplier qualification processes and recommending solutions for implementation
Middle (2-5 ani), Fără experiență, Entry (0-2 ani)
Salariu confidențial
Anunțuri Arhivate
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Specialist Regulatory Submissions Maintenance
Calea Torontalului, Timișoara
expirat: 22.03.2024
Middle (2-5 ani), Fără experiență, Entry (0-2 ani)
Salariu confidențial
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Anunțuri Arhivate
Manager Global Quality Supplier Qualification
Calea Torontalului, Timișoara
expirat: 22.03.2024
Middle (2-5 ani), Fără experiență, Entry (0-2 ani)
Atribuțiile:
Lead and coordinate Global GMP-related auditing and qualification processes to maintain high standards of quality and compliance across all operations
Collaborate with internal and external stakeholders to develop and maintain annual audit plans, ensuring alignment with regulatory guidelines and company standards
Manage supplier qualification records and departmental databases, ensuring accurate documentation and timely updates
Facilitate communication and correspondence with international partners, including internal teams, external auditors, and regulatory bodies
Assist in preparing comprehensive documentation for audits, including product manufacturing records, testing documentation, and audit reports
Participate in training programs and workshops to enhance team skills and knowledge in global quality assurance practices
Contribute to continuous improvement initiatives by identifying areas for enhancement in supplier qualification processes and recommending solutions for implementation
Manager of Product Stability&Quality Documentation
Calea Torontalului, Timișoara
expirat: 31.03.2022
Entry (0-2 ani)
Atribuțiile:
Act as an expert for analytical method transfer documentation, support and first contact for troubleshooting for receiving labs during Analytical Method Transfer (AMT)
Perform „state-of-the-art “checks of existing analytical methods and lead the decision for re-development and/or (re)validation
Planning, initiation and maintain ICH stability studies
Statistical evaluation and assessment, extrapolation of stability study results in relation to issues of product quality
Support and guide external labs within method development and validation
Support Regulatory Affairs with respect to special requests and answer deficiency letters
Inspection / audit of internal manufacturing sites within STADA group to check quality of manufactured products as per EU GMP guideline, applicable local regulation and quality standards
Preparation of internal audit reports and audit evaluations to be submitted to STADA Arzneimittel AG Germany in supporting the inspection readiness related with sourcing, procuring, arranging, exporting, importing and supplying formulations (medicinal, food products etc..) and such other finished goods for own sites
Planning, Preparing, Conducting and Reporting of GMP/GDP and Quality system audits (onsite or virtual assessment) at own manufacturing sites within STADA group
Ensures in-time internal audit plan compilation, audit report generation, CAPA plan review and acceptance, and audit closure
Ensures monitoring of internal audit process performance with applicable KPIs
Responsible for sharing information about internal audit outcome to Global Quality Vendor Qualification team and to applicable personnel
Support to Health Authority (HA) inspected sites within STADA group to define appropriate action related with detected HA inspection findings
Participates in global projects and ensures timely implementation in global department