GxP Compliance Manager

Job DescriptionWe are seeking a highly skilled and experienced R&D Quality Assurance Specialist to join our team. The successful candidate will be responsible for maintaining and developing our R&D QMS, ensuring compliance with ISO 15378 and ISO 13485. Additionally, they will manage the R&D CAPA process and perform internal audits.

This role requires a deep understanding of quality systems and supplier management, as well as the ability to interpret and make decisions based on company policies/procedures and regulatory agencies.You will be responsible for ensuring that all quality agreements are executed per expected timelines and developing, implementing, and maintaining oversight of...

Key ResponsibilitiesMaintain and develop the R&D QMS to ensure compliance with quality management systems.Manage the CAPA process according to ISO 15378 and ISO 13485 standards.Drive continuous improvement within R&D and on its interfaces.Ensure compliant harmonized development documentation.RequirementsUniversity degree in Engineering, Life Science or...

CSL Vifor ist ein weltweit führendes Pharmaunternehmen, das sich auf die Entwicklung, Herstellung und Vermarktung von innovativen Therapien zur Behandlung von Eisenmangel, nephrologischen und kardiovaskulären Erkrankungen spezialisiert hat.Für unseren Standort in St. Gallen suchen wir eine/nCompliance Manager/in ProductionIHRE AUFGABEN:Zeitgerechte...

Cybersecurity Risk ManagerOctapharma is a leading company in the worldwide market for therapeutic human proteins. We are seeking a skilled Cybersecurity Risk Manager to join our team and contribute to our common goal – developing lifesaving therapies to improve patients' lives.Main Responsibilities:Cybersecurity Risk Assessment and Management: Conduct...

Job Description:This Senior Lead Auditor role is responsible for executing quality systems audits of approved suppliers in the pharmaceutical industry. The ideal candidate will have a strong understanding of GxP regulations and a proven track record of ensuring supplier compliance.Main Responsibilities:Plan, execute, and follow-up on assigned audits to...

Business Information Security ConsultantAs a leading company in the human protein market, Octapharma is seeking a skilled Business Information Security Consultant to help us protect our business operations and assets.Main Responsibilities:Cybersecurity Risk Assessment and Management: Conduct regular risk assessments specific to OT environments, identifying...

Job Overview:The Senior Lead Auditor, External Supplier Quality position plays a critical role in ensuring the quality of our suppliers. This includes conducting regular audits to assess their compliance with our quality standards.Key Accountabilities:Conduct remote/desk audits of approved suppliers to evaluate their quality systemsPrepare audit reports and...

Simpson Judge needs a Senior Manager Finance to manage our financial operations, including budgeting, forecasting, and financial analysis. The ideal candidate will have strong hands-on financial management skills and experience leading a small team.We require a candidate with at least 5 years of experience in a senior finance role, preferably within the...

Industrial Cybersecurity OfficerWe are seeking a highly skilled Industrial Cybersecurity Officer to join our team and help us ensure the security and integrity of our industrial control systems.Main Responsibilities:Cybersecurity Risk Assessment and Management: Conduct regular risk assessments specific to OT environments, identifying vulnerabilities,...

The Enterprise Logistics Strategy, Governance & Systems Specialist is responsible for assessment, design and implementation of logistics process and systems in agreement with your direct manager. You will ensure continuous improvement and optimization of processes relevant to customer order fulfillment, Logistics sub functions, end-to-end value chains, as...

Über unsWir sind ein zukunftsorientiertes Unternehmen, das sich für das Gemeinwohl der Gesellschaft einsetzt. Mit rund 6000 Mitarbeitenden bieten wir eine vielfältige Palette von Leistungen an, die alle Aspekte des Lebens umfassen, sei es Bildung, Wirtschaft, Recht, Sicherheit, Natur, Gesundheit, Bau, Kultur und Finanzen.AufgabenAls Service Manager/in...

Job OverviewWe are seeking a highly skilled Project Financial Manager to join our team at Ansaldo Energia Group. In this role, you will play a key part in monitoring and controlling the financial performance of long-term service projects.You will work closely with project managers and other departments to ensure that projects are completed on time, within...

Job RequirementsWe are looking for a highly skilled Service Project Manager to join our team at Ansaldo Energia Group. As a key member of our project management department, you will be responsible for managing the financial performance and progress of long-term service projects.Your primary objective will be to work closely with project managers and other...

IHRE AUFGABEN:Zeitgerechte Eröffnung und Abarbeitung von Abweichungen sowie zugehörigen CAPA'sKontinuierliche Verbesserung von abweichungsbezogenen KPI's (z.B. Scrap Rate, Deviation pro Batch, Right First Time Rate)Abschluss von Inspektionen ohne Mangel und sicherstellen der permanenten InspektionsbereitschaftAneignen von detailliertem Knowhow über die...

IHRE AUFGABEN:Zeitgerechte Eröffnung und Abarbeitung von Abweichungen sowie zugehörigen CAPA'sKontinuierliche Verbesserung von abweichungsbezogenen KPI's (z.B. Scrap Rate, Deviation pro Batch, Right First Time Rate)Abschluss von Inspektionen ohne Mangel und sicherstellen der permanenten InspektionsbereitschaftAneignen von detailliertem Knowhow über die...

OT Resiliency SpecialistWe are looking for an experienced OT Resiliency Specialist to join our team and help us ensure the reliability and resilience of our operational technology systems.Main Responsibilities:Cybersecurity Risk Assessment and Management: Identify vulnerabilities, potential threats, and the impact on critical systems.Compliance and...

We are looking for a (Senior) Lead Auditor, External Supplier Quality to join our Quality team in St. Gallen on a permanent basis. You will support the local site regarding supplier/third-party qualification status and process and will report directly to the Head of Supplier Quality Management (CH). We are offering a flexible and hybrid working model.Main...

Sicherheit durch ExpertiseAls Fachmann für steuerliche Verrechnungspreise verfügen Sie über umfassende Kenntnisse in diesem Bereich. Sie werden unser Hauptansprechpartner bei allen Fragen zu steuerlichen Verrechnungspreisen sein.In dieser Funktion werden Sie auch dafür sorgen, dass alle steuerlichen Verrechnungspreis-Compliance-Anforderungen erfüllt...

Key Responsibilities:Review and process legal requests: Review and process legal requests related to privacy claims, defamation, fraud, and falsification.Ensure compliance: Ensure compliance with client policies and guidelines.Work efficiently: Work efficiently within set turnaround times and maintain high-quality standards.No direct user interaction: This...