Empleos actuales relacionados con Validation & Compliance specialist - Lab. Equipments - Barcelona, Barcelona - Michael Page
-
Data Validation Specialist
hace 2 semanas
Barcelona, Barcelona, España Ambit Bst A tiempo completoJob Summary:We are seeking a highly skilled Data Validation Specialist to join our team at Ambit Bst. As a Data Validation Specialist, you will be responsible for ensuring the accuracy and integrity of data systems in the pharmaceutical industry.Key Responsibilities:Validation support of global testing applicationsEnsuring compliance with validation planning...
-
Computer System Validation Specialist
hace 1 semana
Barcelona, Barcelona, España Kymos Group A tiempo completoJob Description:Kymos Group, a leading analytical services provider for the pharmaceutical industry, is seeking a highly skilled professional to join our team as a Computer System Validation Specialist.The ideal candidate will possess a strong background in computer system validation, with a focus on ensuring compliance with cGMP and GLP regulations. This...
-
Technical Compliance Specialist
hace 2 semanas
Barcelona, Barcelona, España Gaming Laboratories International A tiempo completoTechnical Compliance SpecialistAt Gaming Laboratories International, we are seeking a Technical Compliance Specialist to join our team. As a key member of our compliance team, you will provide technical consulting services to regulators, manufacturers, and engineering staff. Your expertise will be essential in reviewing and evaluating technical matters...
-
Quality Validation Specialist
hace 6 días
Barcelona, Barcelona, España Ecolab A tiempo completoAbout Computer Systems ValidationEcolab seeks a Quality Validation Specialist to join our Computer Software Assurance & Validation Team. The ideal candidate will possess a deep understanding of computerized system validation best practices and industry standards.Key Responsibilities:Lead business risk and impact determinations to determine when validation is...
-
Computer System Validation Specialist
hace 3 semanas
Barcelona, Barcelona, España Centrient Pharmaceuticals Netherlands A tiempo completoJob Title: Computer System Validation SpecialistCentrient Pharmaceuticals Netherlands is seeking a highly skilled Computer System Validation Specialist to join its Global Quality department in Barcelona. As a CSV Specialist, you will play a critical role in maintaining the validated state of global IT systems, ensuring compliance with cGMP, GxP, and other...
-
Computer System Validation Specialist
hace 3 semanas
Barcelona, Barcelona, España Centrient Pharmaceuticals Netherlands A tiempo completoJob Title: Computer System Validation SpecialistCentrient Pharmaceuticals Netherlands is seeking a highly skilled Computer System Validation Specialist to join its Global Quality department in Barcelona. As a CSV Specialist, you will play a critical role in maintaining the validated state of global IT systems, ensuring compliance with cGMP, GxP, and other...
-
Computer System Validation Specialist
hace 3 semanas
Barcelona, Barcelona, España Centrient Pharmaceuticals A tiempo completoJob Title: Computer System Validation SpecialistCentrient Pharmaceuticals, a leading manufacturer of beta-lactam antibiotics and provider of next-generation statins and anti-fungals, is seeking a skilled Computer System Validation Specialist to join its Global Quality department in Barcelona.About the RoleThe successful candidate will be responsible for...
-
Computer System Validation Specialist
hace 3 semanas
Barcelona, Barcelona, España Centrient Pharmaceuticals A tiempo completoJob Title: Computer System Validation SpecialistCentrient Pharmaceuticals, a leading manufacturer of beta-lactam antibiotics and provider of next-generation statins and anti-fungals, is seeking a skilled Computer System Validation Specialist to join its Global Quality department in Barcelona.About the RoleThe successful candidate will be responsible for...
-
Computer System Validation Specialist
hace 3 semanas
Barcelona, Barcelona, España Centrient Pharmaceuticals A tiempo completoJob Title: Computer System Validation SpecialistCentrient Pharmaceuticals, a leading manufacturer of beta-lactam antibiotics, is seeking a skilled Computer System Validation Specialist to join its Global Quality department in Barcelona. As a key member of the IT Quality and Validation team, you will be responsible for maintaining the validated state of...
-
Data Validation Specialist
hace 3 semanas
Barcelona, Barcelona, España Ambit A tiempo completoJoin Ambit as a Validation Consultant for DataAre you looking for a challenging role in a global, multicultural, and multilingual team? Do you have experience in compliance, data management, and validation? We are seeking a skilled Validation Consultant for Data to join our team at Ambit.Key Responsibilities:Provide validation support for global testing...
-
Data Validation Specialist
hace 3 semanas
Barcelona, Barcelona, España Ambit A tiempo completoJoin Ambit as a Validation Consultant for DataAre you looking for a challenging role in a global, multicultural, and multilingual team? Do you have experience in compliance, data management, and validation? We are seeking a skilled Validation Consultant for Data to join our team at Ambit.Key Responsibilities:Provide validation support for global testing...
-
Data Validation Specialist
hace 2 semanas
Barcelona, Barcelona, España Ambit Bst A tiempo completoJob Summary:As a Validation Consultant for Data at Ambit Bst, you will play a crucial role in ensuring the integrity and accuracy of our data systems. Your mission will be to provide validation support for global testing applications, ensuring compliance with validation planning and applicable SOPs. You will be responsible for maintaining the validated...
-
Data Validation Specialist
hace 2 semanas
Barcelona, Barcelona, España Ambit A tiempo completoJob Summary:We are seeking a highly skilled Data Validation Specialist to join our team at Ambit. As a key member of our global, multicultural, and multilingual team, you will be responsible for providing demand management, project management, and data integrations to connect systems in a multinational pharmaceutical environment.Key Responsibilities:Ensure...
-
Computer System Validation Specialist
hace 2 meses
Barcelona, Barcelona, España Centrient Pharmaceuticals Netherlands A tiempo completoJob SummaryCentrient Pharmaceuticals Netherlands is seeking a highly skilled Computer System Validation Specialist to join its Global Quality department in Barcelona. As a key member of the team, you will be responsible for maintaining the validated state of global IT systems, ensuring compliance with regulatory requirements, and embedding quality and...
-
Computer System Validation Specialist
hace 2 meses
Barcelona, Barcelona, España Centrient Pharmaceuticals Netherlands A tiempo completoJob SummaryCentrient Pharmaceuticals Netherlands is seeking a highly skilled Computer System Validation Specialist to join its Global Quality department in Barcelona. As a key member of the team, you will be responsible for maintaining the validated state of global IT systems, ensuring compliance with regulatory requirements, and embedding quality and...
-
Computer System Validation Specialist
hace 2 semanas
Barcelona, Barcelona, España Centrient Pharmaceuticals Netherlands A tiempo completoCentrient Pharmaceuticals is a leading manufacturer of beta-lactam antibiotics and a provider of next-generation statins and anti-fungals. We produce and sell intermediates, active pharmaceutical ingredients, and finished dosage forms.We stand proudly at the center of modern healthcare, as a maker of essential and life-saving medicines. Our commitment to...
-
Technical Compliance Specialist
hace 2 semanas
Barcelona, Barcelona, España Gaming Laboratories International A tiempo completoAbout the RoleThe Technical Compliance Specialist provides technical consulting services to regulators, manufacturers, and engineering staff. This position is responsible for reviewing and evaluating technical matters related to gaming regulatory compliance.Key ResponsibilitiesAct as a technical conduit between regulators and laboratory testing or 'lab...
-
Computer System Validation Specialist
hace 3 semanas
Barcelona, Barcelona, España Centrient Pharmaceuticals Netherlands A tiempo completoAbout the RoleCentrient Pharmaceuticals, a leading manufacturer of beta-lactam antibiotics, is seeking a skilled Computer System Validation Specialist to join its Global Quality department in Barcelona. As a key member of the team, you will be responsible for maintaining the validated state of global IT systems, ensuring compliance with regulatory...
-
Compliance Specialist
hace 3 semanas
Barcelona, Barcelona, España Denexus A tiempo completoJob Title: Compliance SpecialistDeNexus is seeking a highly skilled Compliance Specialist to join our team. As a Compliance Specialist, you will play a critical role in ensuring our products, services, and internal practices adhere to regulatory requirements and industry standards.Key Responsibilities:Manage and maintain internal compliance programs,...
-
Verification and Validation Specialist
hace 3 semanas
Barcelona, Barcelona, España Grooo A tiempo completoJob Title: Verification and Validation EngineerGrooo is seeking a skilled technical expert to join our team as a Verification and Validation Engineer. The ideal candidate will have a strong background in test automation, network protocols, and video management software integration.Key Responsibilities:Develop and execute comprehensive test plans, test cases,...
Validation & Compliance specialist - Lab. Equipments
hace 3 meses
International pharmaceutical company focused on speciality generics
Descripción
The main activities will be focused on acting as a Contract Manufacturing Organization (CMO) for aseptic filling of generic and biosimilar products, by the pharmaceutical forms of vials and pre-filled syringes.
Additionally, through their R&D premises, the pharmaceutical company will also take the responsibility for importing Final Dosage Forms (FDF) inside EU markets from other third countries, as well as their technology transfer.
The proposed company is looking for a Validation & Compliance specialist - Lab. Equipments who will assure the creation, development and implementation of below described responsibilities.
Responsibilities:
-Lead and/or participate in project for the installation of new laboratory's equipment's inside R&D and QC department.
-Update and manage Validation Master Plan according to the Annex 15 of EU-GMP.
-Managing of initial validation and qualification, as well as requalification documentation for laboratory equipment.
-Lead the execution on DQ/IQ/OQ/PQ activities for laboratory equipment's premises.
-Laboratory equipment maintenance management, in close cooperation with equipment supplier by definition of service agreements.
-Ensure that the R&D and Quality Control SOP and Working Instructions are aligned with the applicable EU and US GMP regulations, mostly for the equipment use and maintenance.
-Establish Key Performance Indicators (KPI) and provide 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 in root cause analysis investigation and execution of CAPA's as part of OOS-OOT, Non-Conformities, Incidents, Complains under R&D and/or Quality Control scope.
-Participate as an expert in laboratory equipment for external and internal audits as well as for the inspections by regulatory authorities.
-Conducting of concerned trainings to the new staff inside R&D/QC department under the Quality Assurance scope, mostly in use of laboratory equipment.
-Support on implementation of Calibration Plan for assigned metrological equipment.
-Performance of Risk Assessment for calibrations as well requalification activities.
¿A quién buscamos (H/M/D)?
Main requirements:
-Master's degree in pharmacy, engineering, biochemistry, biotechnology or chemistry.
-Minimum 2 years of work experience in Quality Control / Quality Assurance environment for pharmaceutical premises which are under the EU-GMP certification, preferably in the aseptic production lines for vials and pre-filled syringes.
-Proven experience in EU-GMP and/or US-FDA inspections
-Good understanding of USP/EP methodologies and ICH guidelines
-Proven ability to plan resources and manage priorities to consistently deliver on time against tight project deadlines
-Ability to work independently and to solve problems
-Ability to effectively and clearly communicate into English and Spanish- both written and verbal.
-Good computer literacy skills in MS Office package as well PDF edition for creation or records. Good knowledge on SAP would be an asset.
-Flexible mind for work in a multinational, multitask and multiteam environment.
¿Cuáles son tus beneficios?
-Deep experience in the opening of a new manufacturing and R&D facility in Spain.
-Indefinite contract term.
-Opportunity to grow from the scratch and work in a multinational team environment.
-Support by the main Ukrainian and other European pharmaceutical companies.
-Competitive remuneration, according to the proven experience.
