Aktuelle Jobs im Zusammenhang mit GxP Validation Specialist - Frankfurt am Main, Hessen - Global Market Solutions GmbH
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GxP Validation Specialist
vor 4 Wochen
Frankfurt am Main, Hessen, Deutschland Global Market Solutions GmbH VollzeitGMS is a leading operational consultancy with expertise in data and digital systems. Our consultants are the missing piece of our customer's digital puzzle, empowering their ongoing digital transformation and transforming challenges into opportunities. We're part of the MoOngy Group, a European network of companies with a focus on IT & Engineering...
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GxP Validation Expert for Life Science
vor 1 Woche
Frankfurt am Main, Hessen, Deutschland Global Market Solutions GmbH VollzeitGlobal Market Solutions GmbH is seeking a highly skilled GxP Validation Expert to join our team in Frankfurt, Rhine-Main Area. As a key member of our Life Science division, you will play a critical role in ensuring the quality and compliance of our clients' regulated environments.About the RoleThis is an exciting opportunity for a seasoned validation...
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Regulatory Compliance Specialist in GxP
vor 4 Wochen
Frankfurt am Main, Hessen, Deutschland Global Market Solutions GmbH VollzeitGMS is a leading operational consultancy with expertise in data and digital systems, operating in the regulated environment of the Life Science industry. We empower our customers' ongoing digital transformation and transform challenges into opportunities.Key ResponsibilitiesAs a Regulatory Compliance Specialist in GxP, you will be responsible for ensuring...
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Regulatory Compliance Specialist in GxP
vor 4 Wochen
Frankfurt am Main, Hessen, Deutschland Global Market Solutions GmbH VollzeitGMS is a leading operational consultancy with expertise in data and digital systems, serving the life sciences industry. Our consultants are the missing piece of our customers' digital puzzle, empowering their ongoing digital transformation and turning challenges into opportunities.Key ResponsibilitiesAs a Qualification/Validation Specialist in GxP, you will...
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Senior Validation Manager
vor 4 Wochen
Frankfurt am Main, Hessen, Deutschland Kopani Consulting GmbH VollzeitWir suchen einen erfahrenen Senior Validation Manager, der unsere Qualitätsziele unterstützt und unsere Prozesse optimiert.AufgabenUnterstützung von Entwicklungs- und Optimierungsprojekten als QM-ExperteÜberprüfung und Freigabe von Qualifizierungs- und ValidierungsverfahrenMitarbeit bei der Qualifizierung von Geräten und Produktionsanlagen,...
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Technical System Validation Specialist
vor 1 Woche
Frankfurt am Main, Hessen, Deutschland Da Vinci Engineering GmbH VollzeitWe are seeking a highly skilled Technical System Validation Specialist to join our team at Da Vinci Engineering GmbH.About UsDa Vinci Engineering GmbH is a dynamic company with a flat hierarchy, dedicated to innovation and excellence in the field of automotive system design and validation.Your Tasks:Review functional and non-functional requirements for...
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Senior Validation Manager
vor 4 Wochen
Frankfurt am Main, Hessen, Deutschland Kopani Consulting GmbH VollzeitWir suchen einen erfahrenen Senior Validation Manager, der unsere Kunden in der Medizintechnikbranche unterstützt. Als Experte für Qualifikation und Validierung, werden Sie unsere Entwicklungs- und Optimierungsprojekte unterstützen, sowie Design-Transfers als QM-Experte durchführen.AufgabenUnterstützung von Entwicklungs- und Optimierungsprojekten sowie...
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Senior Validation Manager
vor 4 Wochen
Frankfurt am Main, Hessen, Deutschland Kopani Consulting GmbH VollzeitWir suchen einen erfahrenen Senior Validation Manager, der sich auf die Qualifizierung und Validierung von Geräten und Produktionsanlagen spezialisiert hat. Als Teil unseres Teams werden Sie an der Entwicklung und Optimierung von Prozessen sowie der Überprüfung und Freigabe von Qualifizierungs- und Validierungsverfahren beteiligt.AufgabenUnterstützung...
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Frankfurt am Main, Hessen, Deutschland agap2 Deutschland VollzeitWir, agap2 Deutschland, suchen einen Computer System Validation Engineer, der sich mit unseren Kunden verbindet und komplexe Projekte erfolgreich durchführt. AufgabenCSV-Projekte führen und Validierungsdokumente erstellenProjekte planen, steuern und umsetzenGxP-konformer Betrieb von AnwendungssystemenRisikoanalysen erstellen und ALCOA-Prinzip...
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Medical Software Validation Expert
vor 3 Wochen
Frankfurt am Main, Hessen, Deutschland SciPro VollzeitWe are seeking a dedicated Software Validation Specialist to ensure the quality and safety of software solutions in the medical device sector.As a key member of our team, you will be responsible for validating software to meet regulatory requirements and developing innovative solutions.Key responsibilities include:Planning, implementing, and documenting...
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Vehicle Validation Specialist
vor 4 Wochen
Frankfurt am Main, Hessen, Deutschland Da Vinci Engineering GmbH VollzeitAt Da Vinci Engineering GmbH, we are seeking a skilled Vehicle Validation Engineer to join our dynamic team. The ideal candidate will be responsible for ensuring the readiness of properties (rigs, vehicles) for testing in a timely and quality manner. Key tasks include planning and executing test activities, developing test cases and methods, and driving...
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DWS Risk Manager Model Validation Specialist
vor 4 Wochen
Frankfurt am Main, Hessen, Deutschland Deutsche Bank VollzeitAbout the RoleWe are seeking a highly skilled Risk Manager to join our team in Model Validation. As a Risk Manager, you will be responsible for conducting model validations on DWS models, both in-house and vendor models, based on regulatory guidance, internal policy and procedures, and best industry practice. You will communicate findings and recommendations...
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Computer System Validation Engineer
vor 3 Wochen
Frankfurt am Main, Hessen, Deutschland agap2 Deutschland VollzeitWir suchen für unser Team in Rhein-Main-Gebiet eine/n Computer System Validation Engineer, um unsere Kunden in komplexen Projekten zu unterstützen und ihre Ziele zu erreichen.Deine AufgabenVerantwortung für CSV-Projekte in Bereichen wie Dokumentenmanagement, IT, Pharmakovigilanz und mehrSelbstständige Planung, Steuerung und Umsetzung von...
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IT Business Solutions Specialist
vor 4 Wochen
Frankfurt am Main, Hessen, Deutschland YanTech Associates VollzeitYanTech Associates is seeking an IT Business Solutions Specialist to enhance the effectiveness of a European-leading Pharmaceutical Manufacturing company's applications and systems while ensuring compliance with GxP quality standards.Key responsibilities:Analyze operations, scope projects, and document process flows in collaboration with production...
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Facility Maintenance Specialist
vor 4 Wochen
Frankfurt am Main, Hessen, Deutschland World Courier (Deutschland) GmbH VollzeitAt World Courier (Deutschland) GmbH, we are seeking a highly skilled Facility Maintenance Specialist to join our team. This role is responsible for ensuring the smooth operation of our facility infrastructure, including maintenance, validation, and qualification of equipment.Key Responsibilities:Coordinate with departments and external vendors to address...
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DWS Risk Manager Model Validation Specialist
vor 4 Wochen
Frankfurt am Main, Hessen, Deutschland 0900 DWS Investment GmbH VollzeitAbout DWSWe're a leading global Asset Manager, committed to making a positive impact on individuals, communities, and the world. As a Risk Manager, you'll play a crucial role in ensuring the integrity of our models and maintaining the trust of our clients.Role OverviewAs a Risk Manager, you'll be responsible for conducting model validations, working closely...
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Quality Assurance Specialist
vor 4 Wochen
Frankfurt am Main, Hessen, Deutschland ARCONDIS VollzeitKey ResponsibilitiesAs a Quality Assurance Specialist at ARCONDIS, you will be responsible for the qualification and validation of equipment, instruments, and facilities. Your tasks will include the preparation of qualification and validation plans for laboratory and production-related processes, as well as the review of specifications and risk analyses.Key...
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System Operations Engineering Specialist
vor 4 Wochen
Frankfurt am Main, Hessen, Deutschland CS GROUP VollzeitJob Title: System Operations Engineering SpecialistJob Description:The CS GROUP is seeking a highly skilled System Operations Engineering Specialist to join our team. As a key member of our operations team, you will be responsible for the operations of systems, including system and ground segment operations, communications & networks operations, system...
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Automotive Development Specialist
vor 4 Wochen
Frankfurt am Main, Hessen, Deutschland GULP – experts united VollzeitAre you passionate about the automotive industry and looking for a challenging role? We are currently seeking an Automotive Development Specialist to join our team at GULP – experts united. As a key member of our team, you will be responsible for the preparation and implementation of validations at component, device, and system levels in pre- and series...
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Senior Quality Assurance Specialist
vor 4 Wochen
Frankfurt am Main, Hessen, Deutschland ARCONDIS VollzeitKey ResponsibilitiesAs a Senior Quality Assurance Specialist at ARCONDIS, you will be responsible for the qualification and validation of equipment, instruments, and facilities. This includes the preparation of qualification and validation plans for laboratory and production-related processes, as well as the review of specifications and risk analyses.Key...
GxP Validation Specialist
vor 1 Monat
As a Qualification/Validation Specialist, you will play a key role in maintaining compliance with Good Manufacturing Practices (GMP) and other relevant regulatory guidelines. Your responsibilities will include ensuring that all equipment, systems, and processes within our GxP-regulated environments are qualified and validated according to industry standards.
Key Responsibilities:- Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment and systems in compliance with GxP guidelines.
- Conduct process validation and equipment qualification activities to ensure that all manufacturing, laboratory, and IT systems meet regulatory requirements.
- Develop and review validation protocols, reports, and standard operating procedures (SOPs).
- Collaborate with cross-functional teams, including Quality Assurance (QA), Engineering, and Production, to ensure smooth validation processes.
- Perform risk assessments to identify potential risks and implement appropriate controls to mitigate those risks.
- Maintain thorough documentation of all qualification and validation activities in compliance with GxP standards.
- Ensure adherence to GAMP 5, GMP, and other relevant regulatory requirements during all validation projects.
- Support internal and external audits by providing validation documentation and addressing any queries related to validation activities.
- Monitor and address any deviations, non-conformances, or changes in validated systems and processes.
- Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
- 2-3 years of experience in validation and qualification of equipment in a GxP-regulated environment.
- Strong knowledge of GMP, GAMP 5, and other regulatory requirements.
- Experience with validation documentation, including writing and reviewing validation protocols and reports.
- Familiarity with risk management tools (e.g., FMEA) and approaches in validation.
- Ability to work collaboratively in cross-functional teams and manage multiple projects simultaneously.
- Strong organizational, communication, and problem-solving skills.
- Attention to detail and a commitment to maintaining high standards of quality and compliance.
- Prior experience in a German-speaking GxP environment (mandatory).
- Experience with computer system validation (CSV) and IT system qualifications (is a plus).
- Native in German (mandatory).
- Residency in Germany, with the ability to work in a hybrid model from Frankfurt, Rhine-Main Area.
- We are a growing company with ambitious targets that stands for expert knowledge, integrity and open-mindedness.
- As a consultant, you will implement a wide range of projects for our well-known customers and offer them your growing expertise.
- Your development is supported by a coach, further training, our in-house learning platform and an internal IT & data network.
- Work-life balance is important to us - you enjoy home office options, have the choice between regional or Germany-wide projects and our philosophy is a 40-hour week.
- We also offer security and stability - our employees are employed on a permanent basis.
At GMS we defend equality and diversity. We create a safe and diverse environment where all the opportunities are equal for all the employees. We do not discriminate based on age, ethnicity, sexual orientation, gender, disability or any factor other than merit. All applications with skills for the position are welcome. Would you like to apply with us? Then we look forward to receiving your CV.
GMS ist eine operative Beratung im Bereich Daten und digitale Systeme im regulierten Umfeld mit Schwerpunkt auf der Life Science Branche.
