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- Efficiently, accurately and reliably ensure that project and / or product activities are delivered in compliance with cGMP requirements and maintenance of the company Quality Management System is assured;
- Manage and participate in Quality Product key activities for the assigned product / projects, and introduction of new products; including (but not limited to) preparation, review and approval of auxiliary documentation, protocols and quality related reports;
- Prepare for and support internal and external site audits...
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...
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...
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...
- Efficiently, accurately and reliably ensure that project and / or product activities are delivered in compliance with cGMP requirements and maintenance of the company Quality Management System is assured;
- Manage and participate in Quality Product key activities for the assigned product / projects, and introduction of new products; including (but not limited to) preparation, review and approval of auxiliary documentation, protocols and quality related reports;
- Prepare for and support internal and external site audits and inspections, conducting regular reviews and...
- Lead and oversee warehouse operations, ensuring safe, timely, and efficient reception, storage, dispensing, packaging, loading, and dispatch of materials and products;
- Plan warehouse activities and operator shifts, anticipating needs and workloads to optimize productivity and resource allocation;
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- 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 and monitor HSE policies and operational programs in the warehouse, ensuring alignment with safety standards;
- Conduct regular checks to ensure warehouse activities comply with HSE practices and cGMP requirements;
- Ensure adherence to the quality policy by warehouse teams and maintain updated departmental IOPs;
- Manage...
- Leadership & Team Development:
- Lead, support, and inspire team members (TMs) in recruitment, onboarding, training, and career development;
- Set clear annual objectives for direct reports and provide ongoing guidance to achieve departmental goals;
- Foster a culture of...
- Contribute to the implementation of strategies on the design, acquisition and maintenance of facilities and equipment to guarantee the maximum reliability of the company assets;
- Provide technical solutions for unexpected events during the life cycle of installations and return such learnings to the ones in charge for engineering standards;
- Participate in the execution of the preventive maintenance plan on...
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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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...
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.
- Fulfill all applicable current Good Manufacturing Practices (cGMP) and Health Safety and Environment (HSE) regulations and relevant legislation by adhering to Hovione´s policies and procedures (COPs, HBR, SOPs and others) and industry standards while conducting all activities;
- Plan and design manufacturing processes that ensure the production of intermediates and final products according to the project plan (reliably, right first time, on time and within budget) and in compliance with cGMP, HSE regulations and internal policies and procedures;
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As a Qualification & Validation Specialist, you will play a key role in ensuring that our facilities, equipment, and systems are fit for purpose and compliant with applicable quality standards. You will work cross-functionally to define and implement best practices in qualification and validation, supporting both local and global initiatives.
Key Responsibilities
- Lead and develop the site supply chain team using servant leadership principles, promoting a culture of coaching, accountability, and alignment with corporate strategy and values.
- Ensure execution of all end-to-end supply chain activities (transportation, warehouse, import/export, distribution, planning) with a focus on long-term performance and...
- Fulfill all applicable current Good Manufacturing Practices (cGMP) and Health Safety and Environment (HSE) regulations and relevant legislation by adhering to Hovione´s policies and procedures (COPs, HBR, SOPs and others) and industry standards while conducting all activities;
- Plan and design manufacturing processes that ensure the production of intermediates and final products according to the project plan (reliably, right first time, on time and within budget) and in compliance with cGMP, HSE regulations and internal policies and procedures;
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- Ensure the maintenance, service, repair and troubleshoot of all equipment and installations (mechanical) on site is performed as per Standard Operating Procedures, Maintenance Work Instructions or engineering best practices;
- Participate in risk assessment of work permits and control of their appropriate execution;
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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...
- Support and mentor production teams to optimize drug product manufacturing processes, minimize downtime, and maximize productivity;
- Identify and troubleshoot operational issues related to equipment and drug product processes, implementing innovative solutions to enhance efficiency and quality;
- Monitor and analyze production data to ensure compliance with regulatory standards and quality control measures;
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