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SDi Digital Group
Barcelona, Cataluña, Spain
As Digital Compliance and Risks Expert, you will join an international and dynamic team, that is engaged in designing and delivering Digital Tech Services. In this role you will deliver mission-critical Quality and Compliance expertise for all Consumer Health Care (CHC) worldwide. The team delivers these solutions and services in a highly compet
Fuente del trabajo: SDi Digital GroupSanofi
Barcelona, Cataluña, Spain
At Sanofi Consumer Healthcare, we have one shared mission – we work passionately, every day, to ‘serve healthier, fuller lives’ now and for the generations to come. In order to do so, we strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmen
Fuente del trabajo: SanofiPQE Group
Barcelona, Cataluña, Spain
Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998 , with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas. Due to our continuous expansion, we are currently looking for a Junior
Fuente del trabajo: PQE Groupmethinks
Barcelona, Cataluña, Spain
You’re one step closer to being part of the team. About Methinks Methinks vision is to provide universal and timely diagnosis for life-saving treatments worldwide. Our first focus is on stroke, the second cause of death and a major cause of disability in the world. Our product is an artificial intelligence medical imaging software capable of pe
Fuente del trabajo: methinksMichael Page
Barcelona, Cataluña, Spain
Corporate position in an international company|Flexibility and homeoffice International diagnostic company (analysis, image and pathology) with more than 30 years in the market, is looking for a Group Quality Management System Manager located in Barcelona. The Group QMS Manager will have the following responsibilities: Participate to the develop
Fuente del trabajo: Michael PageUnilabs
Barcelona, Cataluña, Spain
The Group Quality Management System Manager is responsible for developing, deploying and maintaining the Group Quality Management System across Unilabs Group in line with our aspiration, the promises we make and the needs of the markets we serve. Responsibilities Participate to the development and deployment of a strong Quality Culture from the com
Fuente del trabajo: UnilabsSanofi
Barcelona, Cataluña, Spain
About the job At Sanofi Consumer Healthcare , we have one shared mission – we work passionately, every day, to ‘serve healthier, fuller lives’ now and for the generations to come. In order to do so, we strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both
Fuente del trabajo: SanofiBabel Profiles
Barcelona, Cataluña, Spain
Product Manager with MedTech Experience with English Barcelona, Spain (hybrid) Employee Product Management Leader and innovative biomedical company is looking for someone ready to proactively bring new ideas to the team, push boundaries, and constantly look for innovation. The company believes on shared success and diverse ways of thinking, here
Fuente del trabajo: Babel ProfilesBarcelona, Cataluña, Spain
Pharmaceutical company with new manufacturing facility in Barcelona|High added value project and development opportunities
In the purpose of international expansion, a consolidated and well-established pharmaceutical company decided to open a new manufacturing facility and R&D premises in the area of Barcelona. The main activities will be focused on acting as a Contract Manufacturing Organisation (CMO) for aseptic filling of generic and biosimilar products. Through the R&D premises, the company will also take the responsibility for importing Final Dosage Forms (FDF) inside EU markets from other third countries.
The Validation and Compliance Manager will have the following requirements:
Development of IT QMS infrastructure and data integrity approach by use of electronic records, digital signatures, blocked excel sheets….
Leading the data integrity and qualification/validation of computerized systems according to Annex 11 of EU-GMP.
Participate in root cause analysis investigation and execution of CAPA's as part of OOS-OOT, Non-Conformities, Incidents, Complains under Warehouse and Computerized systems scope.
Leading software management support related to Quality Activities in cooperation with assigned Quality Management System Compliance Manager.
Leading and updating the integration of BMS (Building Management System), SAP, CCTV and Particles Size Monitoring software inside quality system.
Preparation of all needed SOPs, WI's and records evidence applied to Warehouse activities and computerized systems.
Establishes Key Performance Indicators and provides product status reporting to the site management on product quality and compliance risks with proposed solutions for improvement of the quality and compliance systems
Participate as an expert in software and warehouse premises for external and internal audits as well as for the inspections by regulatory authorities.
Active support in Qualification Activities, SAT/FAT/IOPQ, Validation applied to Software's and production, laboratory, warehouse and general core data center.
Coordinate supplier audits during the qualification and validation phase focused on Computerized Systems and Warehouse/Manufacturing/laboratory, if needed.
Participate as an expert in software and warehouse/manufacturing/laboratory premises for external and internal audits as well as for the inspections by regulatory authorities.
Conducting of concerned trainings to the new staff inside Software Systems department under the Quality Assurance scope.
Career opportunities and professional development.
Salary according to market and value of the candidate.
Work closely with cross-functional teams, including Manufacturing, Quality Assurance, and Engineering & Science and Technology.
Flexible work schedule.
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Validation and Compliance Manager - Computerized Systems ofertas de trabajo en Barcelona, Cataluña, Spain
ⓘ Se produjo un error inesperado al procesar tu solicitud.
Por favor, actualiza la página e inténtalo de nuevo.
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Prepárate para descubrir tu próxima gran oportunidad.