Aktuelle Jobs im Zusammenhang mit CSV_CSA Support and Validation Coordinator - Bad Homburg - Fresenius Medical Care
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Computer System Validation Manager
vor 4 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Digital Technology GmbH VollzeitJob DescriptionFresenius Digital Technology GmbH is seeking a highly skilled Computer System Validation Manager to join our team in Bad Homburg, Germany.Key ResponsibilitiesDevelop and implement validation and qualification strategies to ensure compliance with regulatory requirements.Lead and coordinate projects in the areas of computer system validation and...
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Computer System Validation Manager
vor 4 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Digital Technology GmbH VollzeitJob DescriptionFresenius Digital Technology GmbH is seeking a highly skilled Computer System Validation Manager to join our team in Bad Homburg, Germany.Key ResponsibilitiesDevelop and implement validation and qualification strategies to ensure compliance with regulatory requirements.Lead and coordinate projects in the areas of computer system validation and...
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Computer System Validation Consultant
vor 2 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Digital Technology GmbH VollzeitJob DescriptionFresenius Digital Technology GmbH is seeking a highly skilled Computer System Validation Consultant to join our team in Bad Homburg, Germany.Key ResponsibilitiesDevelop and implement validation and qualification strategies for computer systemsEnsure compliance with regulatory requirements, such as GMP and FDALead and coordinate projects in the...
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Computer System Validation Consultant
vor 2 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Digital Technology GmbH VollzeitJob DescriptionFresenius Digital Technology GmbH is seeking a highly skilled Computer System Validation Consultant to join our team in Bad Homburg, Germany.Key ResponsibilitiesDevelop and implement validation and qualification strategies for computer systemsEnsure compliance with regulatory requirements, such as GMP and FDALead and coordinate projects in the...
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Computer System Validation Manager
vor 4 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Digital Technology GmbH VollzeitJob DescriptionFresenius Digital Technology GmbH is seeking a highly skilled Computer System Validation Manager to join our team in Bad Homburg, Germany.Key ResponsibilitiesDevelop and implement validation and qualification strategies for computer systemsEnsure compliance with regulatory requirements and industry standardsLead and coordinate projects in the...
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Computer System Validation Manager
vor 4 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Digital Technology GmbH VollzeitJob DescriptionFresenius Digital Technology GmbH is seeking a highly skilled Computer System Validation Manager to join our team in Bad Homburg, Germany.Key ResponsibilitiesDevelop and implement validation and qualification strategies for computer systemsEnsure compliance with regulatory requirements and industry standardsLead and coordinate projects in the...
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Computer System Validation Consultant
vor 2 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Digital Technology GmbH VollzeitJob DescriptionFresenius Digital Technology GmbH is seeking a highly skilled Computer System Validation Consultant to join our team in Bad Homburg, Germany.Key ResponsibilitiesDevelop and implement validation and qualification strategies for computer systemsEnsure compliance with regulatory requirements and industry standardsLead and coordinate projects in...
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Computer System Validation Consultant
vor 2 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Digital Technology GmbH VollzeitJob DescriptionFresenius Digital Technology GmbH is seeking a highly skilled Computer System Validation Consultant to join our team in Bad Homburg, Germany.Key ResponsibilitiesDevelop and implement validation and qualification strategies for computer systemsEnsure compliance with regulatory requirements and industry standardsLead and coordinate projects in...
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Computer System Validation Manager
vor 4 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Digital Technology GmbH VollzeitJob DescriptionFresenius Digital Technology GmbH is seeking a highly skilled Computer System Validation Manager to join our team in Bad Homburg, Germany.Key ResponsibilitiesDevelop and implement validation and qualification strategies to ensure compliance with regulatory requirements.Lead and coordinate projects in the areas of computer system validation and...
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Computer System Validation Manager
vor 4 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Digital Technology GmbH VollzeitJob DescriptionFresenius Digital Technology GmbH is seeking a highly skilled Computer System Validation Manager to join our team in Bad Homburg, Germany.Key ResponsibilitiesDevelop and implement validation and qualification strategies to ensure compliance with regulatory requirements.Lead and coordinate projects in the areas of computer system validation and...
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Computer System Validation Consultant
vor 3 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Digital Technology GmbH VollzeitJob DescriptionFresenius Digital Technology GmbH is seeking a highly skilled Computer System Validation Consultant to join our team in Bad Homburg, Germany.Key ResponsibilitiesDevelop and implement validation and qualification strategies for computer systemsEnsure compliance with regulatory requirements and industry standardsLead and coordinate projects in...
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Computer System Validation Consultant
vor 3 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Digital Technology GmbH VollzeitJob DescriptionFresenius Digital Technology GmbH is seeking a highly skilled Computer System Validation Consultant to join our team in Bad Homburg, Germany.Key ResponsibilitiesDevelop and implement validation and qualification strategies for computer systemsEnsure compliance with regulatory requirements and industry standardsLead and coordinate projects in...
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Computer System Validation Consultant
vor 4 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Digital Technology GmbH VollzeitJob DescriptionFresenius Digital Technology GmbH is seeking a highly skilled Computer System Validation Consultant to join our team in Bad Homburg, Germany.Key ResponsibilitiesDevelop and implement validation and qualification strategies for computer systemsEnsure compliance with regulatory requirements and industry standardsLead and coordinate projects in...
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Computer System Validation Consultant
vor 4 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Digital Technology GmbH VollzeitJob DescriptionFresenius Digital Technology GmbH is seeking a highly skilled Computer System Validation Consultant to join our team in Bad Homburg, Germany.Key ResponsibilitiesDevelop and implement validation and qualification strategies for computer systemsEnsure compliance with regulatory requirements and industry standardsLead and coordinate projects in...
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Customer Service Coordinator
vor 3 Wochen
Bad Vilbel, Hessen, Deutschland DQS GmbH VollzeitJob DescriptionCustomer Service CoordinatorWe are seeking a highly motivated and customer-focused Customer Service Coordinator to join our team at DQS GmbH. As a key member of our customer service team, you will be responsible for providing exceptional customer service and support to our clients.Key Responsibilities:Provide timely and effective customer...
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Customer Service Coordinator
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Customer Service Coordinator
vor 2 Wochen
Bad Vilbel, Hessen, Deutschland DQS GmbH VollzeitJob DescriptionCustomer Service CoordinatorWe are seeking a highly motivated and customer-focused Customer Service Coordinator to join our team at DQS GmbH. As a key member of our customer service team, you will be responsible for providing exceptional customer service and support to our clients.Key Responsibilities:Provide timely and effective customer...
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Customer Service Coordinator
vor 2 Wochen
Bad Vilbel, Hessen, Deutschland DQS GmbH VollzeitJob DescriptionCustomer Service CoordinatorWe are seeking a highly motivated and customer-focused Customer Service Coordinator to join our team at DQS GmbH. As a key member of our customer service team, you will be responsible for providing exceptional customer service and support to our clients.Key Responsibilities:Provide timely and effective customer...
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Global Transfer Project Coordinator
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Bad Vilbel, Hessen, Deutschland STADA Arzneimittel AG VollzeitJoin Our Team as a Global Transfer Project CoordinatorAt STADA Arzneimittel AG, we are committed to improving the health of people worldwide. As a Global Transfer Project Coordinator, you will play a crucial role in supporting our Global Transfer Project Management Team in various activities related to project management, data management, and data...
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IT Specialist
vor 3 Wochen
Bad Wörishofen, Bayern, Deutschland U.S. Army Europe and Africa VollzeitIT Specialist (Customer Support) - U.S. Army Europe and AfricaJoin the U.S. Army Europe and Africa team as an IT Specialist (Customer Support) and play a critical role in providing technical support to our customers. As a member of our Network Enterprise Center (NEC) team, you will be responsible for performing Break/Fix, Tier 1 remote administration and...
CSV_CSA Support and Validation Coordinator
vor 3 Monaten
Goal of Function:
The primary goal of the CSV/CSA Support and Validation Coordinator is to ensure the integrity, quality, and compliance of the GPDM Polarion Tool through rigorous Computer System Validation (CSV) and Computer Software Assurance (CSA) activities. This role involves supporting the CSV/CSA lead, coordinating efforts across various FMC teams globally, and ensuring that all validation and assurance processes meet regulatory and internal standards. The Coordinator will play a crucial role in planning, executing, and documenting validation activities, as well as in facilitating seamless integration and communication between ALM, PLM, and ERP systems.
Tasks and Responsibilities:
Support CSV/CSA activities for the GPDM Polarion Tool. Assist CSV/CSA lead in the Global PDM Team. Plan and coordinate all CSV/CSA activities between FMC CSV/CSA teams (EMEA and NA) and work streams to enable coordinated system releases across FME. Support technical writing and creation of CSV/CSA deliverables based on input from work streams and FMC global topic owners. Coordinate CSV activities for ALM systems and manage interfaces between ALM, PLM, and ERP systems. Participate in the development and revision of the PCP to ensure compliance with CSA procedures. Assist in handling CSA discrepancies and training project members on CSA relevant topics. Ensure all CSA documentation follows good documentation practice (GDP) and is maintained in the correct sequential order. Perform quality gate reviews and verify business-relevant activities before business go-live. Create and manage the go-live approval sheet (GLAS). Maintain CSA documentation for regulatory reviews and supervise all CSA activities. Provide technical writing support for CSA documentation.Education & Qualifications:
Bachelor's degree in Engineering, Computer Science, Information Technology, or a related field. An advanced degree (, Master's, PhD) in a relevant field is preferred. Specialized further education or certification in Computer System Validation (CSV), Computer Software Assurance (CSA), or related areas is highly desirable. Minimum of 5 years in CSV/CSA activities and IT system validation, preferably in a regulated industry such as medical devices, pharmaceuticals, or biotechnology. Extensive experience in program/project management and quality assurance in a regulated environment, with a strong understanding of FDA Quality System Regulations (QSR), 21 CFR Part 11, and GAMP5 guidelines. Proven track record of managing multiple validation projects and coordinating with cross-functional teams. Strong analytical and problem-solving skills with the ability to manage complex validation activities. Excellent communication and interpersonal skills, capable of effectively collaborating with global teams and stakeholders. High attention to detail and commitment to quality and compliance. Ability to work independently and take initiative in a fast-paced, dynamic environment. Deep understanding of ALM (Application Lifecycle Management), PLM (Product Lifecycle Management), and ERP (Enterprise Resource Planning) systems. Familiarity with tools such as Polarion, Windchill, Thingworx, and Azure DevOps. Proficient in English; proficiency in German is an advantage. Advanced skills in digital technologies and IT systems relevant to CSV/CSA activities. Knowledge of industry best practices and regulatory requirements for system validation in a global context. Especially Windchill and Polarion Willingness to travel globally up to 20% of the time. Ability to work flexible hours, including weekends or shifts, as needed to meet project deadlines. Career with a purposeWe offer an opportunity to create and deliver treatments that save and change lives for the better. We’ll support your ongoing development. And you’ll be part of a dedicated team of people who inspire each other to create the best possible healthcare outcomes each and every day. Inclusion and diversityJoining Fresenius Medical Care means becoming part of a team that values diversity. We embrace the wealth of different backgrounds, cultures, experiences and opinions that make up our workforce and strive to create an inclusive atmosphere in which all our employees feel valued. StabilityDeveloping innovative products and continuously improving our renal therapies made us the clear market leader in the production of hemodialysis machines, with sustainable, profitable growth . This position provides our 125000 employees with the stability and security they need to help improve the lives of our patients. Learning and developmentWe offer participation in programs at world-class business schools, leadership development, regular training for our nurses, health care professionals and manufacturing staff and digital access to high-quality educational content for all employees worldwide 24/7. Local benefitsOur employees enjoy both local and global opportunities for growth and personal fulfilment. We offer local benefits designed to suit the requirements of the respective country and place of work to create ideal conditions everywhere. Work-life balanceWe want to empower people to deliver better care. Therefore, we promote a better work-life balance through flexible working hours, part-time models, the possibility to work from home, and more.