PRODUCT QUALITY LEAD
Descripción de la oferta de empleo
About the Role Major accountabilities.
Accountable for end-to-end quality stewardship (DS and DP) of assigned Novartis biologics product(s) (NBE’s and biosimilars) from late phase development to discontinuation.
Accountable for the end-to-end product quality strategy (DS and DP) across the global network and drive continual improvement through product and process lifecycle management, represent QBT&A in cross-functional project life cycle team.
Provide expert quality guidance, technical support and quality leadership for implementation of quality guidelines, regulations, standards, processes, and strategy for assigned product(s) throughout the product and process lifecycle.
Maintain global Quality oversight, oversee global regulatory filing activities including product registration and variation management, of assigned Novartis biologics product(s) (NBE’s and biosimilars) Act as global quality lead in product related Q escalations, recalls and BPDR handling for product specific quality and compliance challenges.
Provide clear direction and drive efficient decision making for global Quality issues related to assigned products.
Involved in major product relevant investigations, in particular multi-sites deviations and recurring devia-tions, by leading / supporting global investigations / Task Force at the sites.
Support global site readiness for product pre-approval inspections across the BT&A platform / network.
Bridge between clinical, development and technical operation teams and engages at multiple interface(s) between the organizations to functionally lead and drive robust execution of the defined Product related Quality Program.
Actively drive platform wide Q strategy harmonization and promote product Quality as competitive ad-vantage.
Minimum Requirements.
Work Experience.
5+ years of experience in an operational GxP area in a Manufacturing/Development or Quality; Solid knowledge in biology/chemistry, pharmacy and biotechnology, medical devices/combination products; Thorough knowledge and expertise in cGMP and applicable guidelines Sound scientific, technical and regulatory knowledge, ideally in Biotechnology; expertise in validation (process and cleaning) a plus; Excellent and proven ability to analyze and evaluate cGMP compliance; Proven ability to influence people and communicate in a process-oriented organization; Fluent English, written and spoken.
Any additional language is a plus.
Detalles de la oferta
- Sin especificar
- En toda España
- Sin especificar - Sin especificar
- 13/12/2024
- 13/03/2025
Cultivating a culture of ownership, collaboration, and a shared passion for delivering quality products... our client, a well established igaming operator, is expanding its international team in malta and seeking to recruit a development team leader (back end)... excellent time management and prioritisation......
Ensure incoming client content meets quality standards and is properly filed... conduct quality checks on finished work before delivery update project plans and maintain project status reports... your role involves overseeing production, negotiate supplier agreements, source the impossible, find solutions......
Responsibilities answer inbound calls from customers to provide after sales support, schedule appointments, provide commercial information, as well as other services as requested by the company within guidelines/goals established by the client and contact center management consistently achieve call,......
· reportar el estado de su plan diario de trabajo al compliance & quality mánager... funciones y tareas:· elaborar plan diario de trabajo junto al compliance & quality mánager· efectuar auditorias de los sistemas de gestión, que les sean encargadas... · gestionar y custodiar toda la documentación necesaria......
Are you a seasoned sales professional with a passion for real estate? do you thrive in a high-energy, team-oriented environment? if so, we have an exciting opportunity for you! we're seeking a dynamic and motivated individual to lead our sales department in a new development project......
Knowledge of the documentation required for product shipment understanding of storage and distribution processes... outstanding organizational abilities... navision erp will be considered a plus... in this role, you will report to the director of the department and will be responsible for providing administrative......
Interpretación de planos, utilizando para ello product view... requisitos del puesto- formación profesional en climatización y refrigeración... actitud positiva, compañerismo, proactividad y flexibilidad... en keyter e intarcon buscamos reforzar nuestro con la incorporación de un/a frigorista......
• acts as the lead coordinator of all disciplines for well-coordinated patient care... pension schemelife insurancehealth insurance, including dental medicine33 days of annual leave including holidays application requirements:eu nationalityeu nursing diplomaprevious uci experiencegood level of spoken......
Display high professional competence and focus on service quality... help maintain a smooth and friendly cooperative environment... what do we offer? employment in one of our 4 *, 4 * superior, or 5 * associated hotels... who are we looking for? hard-working, enthusiastic, and adventurous people who......
Contact us and we will accompany you through the whole employment process! at the moment we are recruiting a motivated chef de partie, for our partner hotel, a luxurious mountain resort in austria, with starting date in july or august 2023: tasks: execute menus in collaboration with other colleagues......
