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- Assist with conducting non-core and intercompany shipments, ensuring compliance with current legislation and regulations;
- Help prepare documentation required to support the transit of goods, ensuring information systems (e.g., CRM, SAP) are updated accordingly;
- Support in keeping the customer master data in SAP updated;
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- Provide support to automation system users. Troubleshoots and diagnoses equipment/system problems / failures. Prepares technical reports to document equipment modifications and equipment maintenance procedures;
- Contributes to the continuous improvement of systems to improve...
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.
- Develop and implement asset management strategies for critical equipment, including PMP, critical spare part identification, and optimization of spare part inventories. Ensure up-to-date and accurate equipment BOM;
- Lead troubleshooting efforts for equipment malfunctions; perform Root Cause Analysis (RCA) and implement effective Corrective and Preventive Actions (CAPA) to minimize downtime;
- Integrate and...
- Implement productivity actions and define priorities within your own work to achieve the proposed goals;
- Lead, manage, and train the teams that will take part in Continuous Improvement Initiatives, problem-solving groups, and risk assessment teams, fostering collaboration and knowledge sharing;
- Support the development of the Operational Excellence Training Program, facilitating and delivering training...
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.
We are seeking an System Administrator capable of design and oversee an enterprise technology landscape. With a good hability to collaborate and guide stakeholders at all levels and that posses an broad technical expertise, with understanding of business and compliance requirements. This role is crucial to our efforts to build scalable, secure, efficient and standard systems aligned with the strategic business goals. • Develop High-Level architectural designs and roadmaps aligned to business...
Defines and implements procedures and processes to assure that Hovione facilities, equipment and supporting systems are fit for purpose and comply with applicable quality standards, documenting evidence that these can perform effectively and reproducibly to meet predetermined specifications and quality attributes to manufacture a product when operated within established parameters. Works collaboratively with colleagues to support the design of test strategies and methodologies for qualification and validation application, by developing and deploying Best Practices.
This person will integrate with the Automation team and will support the qualification and validation from a point of view of Quality to guarantee the GMP standard of the process. They will also be required to:
- Support site personnel in all Automation Qualification and Validation activities
- Plan and/or establish Qualification/Validation requirements ensuring Compliance with relevant guidelines and procedures.
- Assure cGMP compliance...
- 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...
Engages in the implementation of the Health, Safety and Environmental Management and Sustainability programs and procedures to safeguard employees and surrounding communities, developing requirements, supporting implementation through training and communication and monitoring implementation through audit and inspection. Conducts and supports incident investigations and risk assessments. Develops and maintains comprehensive knowledge and familiarity of regulatory and organization requirements and standards and works to ensure these requirements are fully implemented.
Performs procurement and sourcing functions which may include but are not limited to short and long-term category strategy development, supplier development and innovation enablement, commodity/services/goods procurement, outsourcing and vendor selection as well as project material sourcing/ planning/scheduling. Creates efficient integrated processes among internal functions and outside suppliers providing an efficient and transparent internal customer experience, compliant with quality assurance and sustainability requirements. Focuses resources on continuous improvement of the movement of materials through various processes and establishes key performance metrics and...
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.
Defines and implements procedures and processes to assure that Hovione facilities, equipment and supporting systems are fit for purpose and comply with applicable quality standards, documenting evidence that these can perform effectively and reproducibly to meet predetermined specifications and quality attributes to manufacture a product when operated within established parameters. Works collaboratively with colleagues to support the design of test strategies and methodologies for qualification and validation application, by developing and deploying Best Practices.
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.
Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.
- Rigorously, accurately, efficiently and professionally manage, execute and support all...
Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.
- Contribute to the area planning and participate in the methodology definition for the...
Responsibility over the development, scale-up of 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.
- Resolve a wide...
Defines and implements procedures and processes to assure that Hovione facilities, equipment and supporting systems are fit for purpose and comply with applicable quality standards, documenting evidence that these can perform effectively and reproducibly to meet predetermined specifications and quality attributes to manufacture a product when operated within established parameters. Works collaboratively with colleagues to support the design of test strategies and methodologies for qualification and validation application, by developing and deploying Best Practices.