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- Review records to ensure compliance with cGMP and HSEE standards
- Make quality and timely decisions within the tasks under her/ his responsibility Propose new methodologies taking into consideration project demands and requirements
- Execute project specific analytical tasks and act as a...
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.
- To organize and define daily priorities within their assigned tasks in order to accurately...
- 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.
Delivers excellence in end-to-end process improvement practices, methodologies and behaviours to achieve transversally operational and support services areas’ efficiencies. Demonstrates particular leadership skills to influence the right behaviours and enable alignment of priorities across areas. Supports the continuous improvement cycle aiming at the sustainable increase of
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.
- Develop and execute commissioning, qualification, and validation protocols (DQ, IQ, OQ) for automation and control systems;
- Ensure compliance with GMP, GAMP 5, and 21 CFR Part 11 during all phases of system implementation and operation;
- Author and maintain validation documentation, including protocols, reports, and traceability matrices for computerized systems;
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·Lead and manage cross-functional IT/OT projects in GMP-regulated pharmaceutical manufacturing environments.
·Oversee implementation and integration of systems such as SAP, MES,...
- 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;
- Enables the efficient manufacture of pharmaceutical products, including highly potent compounds, in compliance with applicable cGMP and HSE regulations and in accordance with business requirements. Responsible for the definition, implementation and optimization of manufacturing processes and...
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.
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Business partnering function supporting Finance and the business. Defines and implements business processes that assess overall performance, identify business drivers, benchmark against relevant KPIs, identify improvement opportunities and promote business process optimization. Defines, produces timely and challenges reports that address performance against budget, profitability, cost, efficiency and risk.
- Prepare, monitor and control the annual...
- Partner with business leaders to develop and implement HR strategies aligned with organizational goals and pharmaceutical industry standards;
- Lead and manage complex HR projects and initiatives with significant business impact, ensuring high operational excellence to accelerate the organization to the next level of transformation;
- Analyze HR metrics and business data to support decision-making and drive...
In this role, you will 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. You will ensure a high level of customer satisfaction by staying closely aligned with their needs and expectations. You will identify and develop new sales opportunities and are typically responsible for successfully closing them. By increasing the visibility and perceived value of the company’s products and services, you will generate demand and strengthen our market...
- Assigned projects that may relate to any of the following (non-exhaustive) areas: Raw Materials, Suppliers, Specifications, Production Processes, Change Control, Deviations, Quality agreements, Qualification and Validation, Stability Programs, Batch Release, Equipment Cleaning, Client Audits, Internal Audits, Customer Complaints and Customer requirements;
- Ensure inspection readiness in work completed and act in an advisory capacity for all internal and external site audits, taking a lead on the most complex situations;
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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 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.
- To organize and define daily priorities within their assigned tasks in order to accurately...
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...