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Guarantees cGMP compliance in all activities and systems related to Projects and Products execution. Assures that working practices are streamlined and aligned with the actual needs of each project. Implements policies, procedures and methods to evaluate and to continuously improve the quality of products and operations throughout the products lifecycle. Provides global supplier qualification services in support of new product introduction and existing products. Collaborates with suppliers and Procurement to assure the quality of their products, materials, components and/or operations.
- Support the Internal Communications team in the planning, creation and rollout of internal communication initiatives and campaigns;
- Assist in the development of creative materials (e.g. posters, infographics) using design tools;
- Draft and edit internal messages and content for various internal channels, such as our internal App, wallpapers, lockscreens and TV screens;
- Contribute to the implementation of internal communication plans to support...
Responsibility over the development, scale-up, registration/validation of drug substance, particle engineering and drug development programs in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Oversees the manufacturing process for clinical or commercial supplies of materials in cooperation with areas and supports safety/hazard analysis and other technical support areas as required. Promotes the scientific excellence and innovation in the area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
Suggests, develops and implements process analytical tools to boost the company efficiency in the areas of Drug Substance, Drug Product Intermediate and Drug Product. Oversees and qualifies the implementation of these tools in the manufacturing assets in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Assures modelling practices and methodologies are aligned with the state of the art. Promotes the scientific excellence and innovation in the area of Modelling and PAT and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
Responsibility over the development, scale-up, registration/validation of drug substance, particle engineering and drug development programs in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Oversees the manufacturing process for clinical or commercial supplies of materials in cooperation with areas and supports safety/hazard analysis and other technical support areas as required. Promotes the scientific excellence and innovation in the area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
The Sourcing Specialist Trainee will learn to make informed procurement decisions during the RFP2Bid and Cost Assessment Processes. This includes actively participating in Screening Meetings to assess potential supply constraints, mitigate risks, and ensure strategic and timeline alignment from the onset of new opportunities. The Trainee will also leverage technical knowledge in chemistry and chemical processes to optimize supplier selection, ensure compliance with industry regulations, and drive alignment between technical requirements and procurement strategies.
The REGENERAR project, spanning four years and commencing on March 1, 2024, aims to develop a non-viral delivery formulation up to TRL4 for gene editing applications. This formulation is intended to promote regeneration in tissues with limited self-repair capabilities.
The consortium comprises six partners from three EU Member States:
- Two academic institutions: University of Coimbra (Portugal) and...
- Conceive, design and implement engineering solutions on the specific areas of engineering projects, towards a successful project conclusion, in order to achieve the company established objectives;
- Prepare, revise and approve technical documentation of engineering projects, for conceptual, basic and detailed design phases;
- Ensure that project documents are complete and optimal for a competitive tender process;
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- Process invoices of national and international vendors (services, products and assets)
- Conduct vendor current account reconciliation with monthly statements
- Verify calculations, checks or information
- Compile summaries of information related to documents processed
- Process travel expenses
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- Develop scalable, secure, and efficient digital architectures that align with organizational goals and industry best practices;
- Collaborate with IT teams to integrate various platforms, systems, and applications ensuring seamless interoperability;
- Work closely with cross-functional teams (development, operations, security, and business units) to ensure digital architecture supports business objectives;
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- Assist in supplier quality related activities in support of business goals
- Follow-up with suppliers to obtain required documentation for approval and maintenance of supplier qualification processes
- Ensure that Hovione receives from the supplier the appropriate documentation to perform the supplier qualification
- Follow-up with internal teams to obtain inputs for approval and maintenance of supplier qualification processes
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Performs procurement and sourcing functions which may include, commodity/services/goods procurement, outsourcing and vendor selection as well as project material sourcing/ planning. Focuses resources on continuous improvement of the movement of materials through various processes and establishes key performance metrics and benchmarks to measure actual performance against goals regularly.
- Develop and execute cost-saving strategies for indirect materials and services.
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- The series of investigative activities to improve existing products and services or to lead to the development of new products and services for Hovione or for our client base. It may result in ownership of intellectual property such as patents. It is the key driving force of innovation and science in the organization, managing new ideas and innovation across the company.
- Conduct routine tasks with regular supervision
- Operate basic equipment and/or machinery
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- The HSE team is responsible for putting into action programs and procedures focused on Health, Safety, Environmental Management, and Sustainability.
- These efforts aim to protect our Team Members and the communities around us.
- The department assists in enforcing best practices through training and inspections, and it also helps with incident investigations and risk assessments.
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Performs procurement and sourcing functions which may include but are not limited to short and long-term category strategy development, supplier development, commodity/services/goods procurement, outsourcing and vendor selection as well as project material sourcing/ planning. Focuses resources on continuous improvement of the movement of materials through various processes and establishes key performance metrics and benchmarks to measure actual performance against goals regularly.
- Lead cross-functional teams to deliver substantial...
- Perform qualitative and quantitative analyses of compounds, including drug substances, drug product intermediates and drug product.
- Recommend the analytical characterization package (Chemical, physical, performance) and control the quality and accuracy of the data in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies.
- Promote the scientific excellence and innovation in the Analytical area and contributes with technical expertise to expand the Intellectual Property,...
Implements and manages the required guidelines and cGMPs for Hovione, providing LEAN based Quality Systems and Tools, controlled, harmonized and aligned with the company’s strategic plan, promoting a rigorous and continuous improvement culture to guarantee high quality compliant sites. Maintains active and efficient communication channels along the several Hovione sites, identifying Quality needs and improvements both from internal and external stakeholders. Evaluates, advises and provides services and technical support, internally and externally, related to the legal and scientific regulatory requirements in relation to product development, commercialization and optimization...
- Provide scientific leadership and act as a subject matter expert in analytical development to support R&D process development and other relevant areas.
- Collaborate effectively with internal and external stakeholders to optimize experimental design, troubleshoot technical challenges, perform sample analysis, interpret data, generate reports, and communicate results promptly to key project stakeholders.
- Recommend and oversee the analytical characterization package (chemical, physical, performance) while ensuring the quality and...