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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...
Job Purpose
The Global Cyber Security Senior Manager is responsible for leading the development, implementation, and continuous improvement of Hovione’s cyber and information security strategy. This role ensures the protection of digital assets, compliance with regulatory requirements, and alignment with enterprise risk management objectives. This role is critical in safeguarding sensitive data,...
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 benchmarks to measure...
Performs qualitative and quantitative analyses of compounds, including drug substances, drug product intermediates and drug product. Recommends the analytical characterization package (Chemical, physical, performance) and controls the quality and accuracy of the data in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Promotes the scientific excellence and innovation in the Analytical 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.
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.
- 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...
- Develop, configure, and implement software for PLC, DCS, and SCADA systems across various automation platforms;
- Translate functional design specifications into reliable and maintainable automation code;
- Troubleshoot and resolve software issues during project execution and post-implementation support phases;
- Build and maintain strong, long-term relationships with senior decision-makers and key influencers within a designated portfolio of customer accounts, which may include major strategic clients in specific geographic or industry sectors
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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.
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.
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Develop detailed civil engineering designs and plans for pharmaceutical facilities;
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Conduct site assessments and feasibility studies for new construction projects;
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Collaborate with architects, mechanical engineers, and other stakeholders to ensure integrated project delivery;
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Builds and maintains effective long-term relationships and a high level of satisfaction with key senior-level decision makers and influencers at an assigned group of customer accounts that may include major strategic customers within a geographic or industry focus. Identifies, develops and closes new sales opportunities. Creates demand for the organization’s products, solutions and services by raising their profile with customers. Achieves revenue targets by increasing revenue spend per account. Negotiates, with autonomy, highly complex and long-term contracts. May conduct regular status and strategy meetings with the customers’ senior management to understand their needs and link them to the...
- 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,...
Promotes and sells a portfolio of products and/or services and solutions directly to current and new end customers. Informs customers of new product/service introduction and prices. Creates, monitors and revises lead generation plans to ensure a substantive sales opportunity pipeline. Negotiates, with autonomy, highly complex contracts.
- Achieve and deliver personal sales targets, maximizing profitability of new business.
- Prospect for new customers and projects through professional...
The Director of Compliance & Innovation will be responsible for the global compliance Strategy and oversight across Hovione´s network, ensuring the highest GMP standards and regulatory readiness either for the current or new business areas.
This is a new role that will strengthen our global compliance profile, drive inspection readiness, and support the integration of new business modalities – particularly in biotechnology and aseptic manufacturing.