Biological Products QA Senior manager
hace 4 días
Mision Lead the development, implementation and oversee of the robust Quality Management System for biopharmaceutical products. Functions & ResponsibilitiesLead the development and implementation of a robust Quality Management System (QMS) specifically tailored for our biopharmaceutical products, ensuring the highest standards of quality and compliance.Oversee all key Quality Systems and deliverables associated with the drug development, playing a pivotal role in the success of our product pipeline.Drive cross-functional projects and Quality initiatives within CMC Teams, providing expert Quality Assurance input for all aspects of the drug development process, ongoing regulatory filings and updates to Health Authorities.Conduct comprehensive risk assessments and communicate Quality risks within the Quality organization, shaping our strategic approach to risk management.Facilitate the resolution of Quality issues on deviations, Investigations, CAPAs, and Complaints in a timely manner, maintaining the integrity of our products and processes by fostering effective interdepartmental and cross-functional relations, promoting a culture of quality across the organization.Manage change control throughout the drug development process, ensuring smooth transitions and continuous improvement.Lead internal quality audits, supplier audits, process/product improvement projects, supplier evaluation surveys, and disposition activities, ensuring our operations meet the highest standards of quality and efficiency.Promote cross-training within the QA team, fostering a versatile and resilient team ready to meet the challenges of a dynamic biopharmaceutical environment.Education Bachelors/Masters Life Science/Engineering (Pharmacy, Bioengineering, Biological Sciences or similar subject). Requirements +8 years quality related experience in pharmaceutical or biopharmaceutical industry of biological products. Strong knowledge of GMP and regulatory requirements (e.g., EU, FDA, ICH). Technical working proficiency in quality systems. Knowledge of devices for biologics (e.g., combination product) would be considered an advantage. Good knowledge and skills in the use of advanced personal computer productivity programs for word processing, spreadsheets, data base manipulations, statistical analytical and flow charts. Strong organizational, analytical mindset, and problem-solving skills to perform varied tasks in a functionally independent and consistent manner with a clear focus on timelines and objectives. Ability to influence and collaborate with others. Good written and verbal communication skills in English are essentials.
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Biological Products QA Senior manager
hace 4 días
España Almirall A tiempo completoFecha: 6 nov. 2024 Ubicación: SAB0 - PHARMA SANT ANDREU DE L Mision Lead the development, implementation and oversee of the robust Quality Management System for biopharmaceutical products. Functions & Responsibilities Lead the development and implementation of a robust Quality Management System (QMS) specifically tailored...
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Senior QA Manager
hace 4 semanas
España Take-Two Interactive Software Inc A tiempo completoPlease note that 2K Games and its studios never uses instant messaging apps or personal email accounts to contact prospective employees or conduct interviews and when emailing, only use 2K.com accounts. Senior QA Manager - Madrid - All resumes in English please Role Overview As the Senior Manager, QA, you will be responsible for leading a team of QA...
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Senior QA Manager
hace 1 mes
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Senior QA Manager
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España 2K A tiempo completoPlease note that 2K Games and its studios never uses instant messaging apps or personal email accounts to contact prospective employees or conduct interviews and when emailing, only use 2K.com accounts. Senior QA Manager - Madrid - All resumes in English please Role Overview To manage the QA Department for assigned projects & staff: managing test process &...
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Senior QA Manager
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España 2K A tiempo completoPlease note that 2K Games and its studios never uses instant messaging apps or personal email accounts to contact prospective employees or conduct interviews and when emailing, only use 2K.com accounts.Senior QA Manager - Madrid - All resumes in English pleaseRole OverviewTo manage the QA Department for assigned projects & staff: managing test process &...
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QA Manager
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España Take-Two Interactive Software Inc A tiempo completoPlease note that 2K Games and its studios never uses instant messaging apps or personal email accounts to contact prospective employees or conduct interviews and when emailing, only use 2K.com accounts.#LI-Onsite QA Manager - Madrid - Please only apply in English with an English Resume.JOIN OUR QA STUDIO IN MADRID!Role OverviewAs the Manager, QA, you will be...
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QA Manager
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España 2K A tiempo completoPlease note that 2K Games and its studios never uses instant messaging apps or personal email accounts to contact prospective employees or conduct interviews and when emailing, only use 2K.com accounts.#LI-OnsiteQA Manager - Madrid - Please only apply in English with an English Resume.JOIN OUR QA STUDIO IN MADRID!Founded in 2005, 2K Games is a global video...
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QA Manager
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España Take-Two Interactive Software Inc A tiempo completoPlease note that 2K Games and its studios never use instant messaging apps or personal email accounts to contact prospective employees or conduct interviews and when emailing, only use 2K.com accounts.#LI-Onsite QA Manager - Madrid - Please only apply in English with an English Resume. JOIN OUR QA STUDIO IN MADRID! Founded in 2005, 2K Games is a global...
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QA Manager
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España 2K Games, Inc. A tiempo completoPlease note that 2K Games and its studios never uses instant messaging apps or personal email accounts to contact prospective employees or conduct interviews and when emailing, only use 2K.com accounts.#LI-Onsite QA Manager - Madrid - Please only apply in English with an English Resume. JOIN OUR QA STUDIO IN MADRID! Founded in 2005, 2K Games is a global...
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España Kapres Technology, S.L. A tiempo completoDesde Kapres Technology estamos buscando a un/a Senior QA Automation Tester para un proyecto internacional en un importante cliente del sector seguros, trabajo 100% remoto (alguna vez iras a conocer al equipo, a Barcelona, pero es en remoto), puesto estable de larga duración. Necesitamos siguiente perfil: Senior QA Automation Tester Description: o QA vision...
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