Jobsuche und Projektbörse
für Fach- und Führungs­kräfte

Bayern | Freiberuflich für ein Projekt | Startdatum: sofort | 479231/1
Optimierung des vorhandenen Quality Management Systems Transfer eines Quality Management Systems
Raum Frankfurt | Freiberuflich für ein Projekt | Startdatum: sofort | 475534/1
Vorbereitung und Abwicklung von Projekten zur Sicherstellung der Datenintegrität in Produktionsprozessen sowie Quality Control und PTC unter Einhaltung regulatorisch relevanter Vorgaben Erstellung und Pflege von Datenflussdiagrammen und Audit Trail-Konzepten Begleitung der Durchführung von Datenintegritätsprüfungen Identifizierung von Datenintegritätslücken und Mitarbeit an Maßnahmen zur Behebung dieser Ansprechpartner und Wissensträger für Fragestellungen im Bereich DI in den zugeordneten Abteilungen Definition, Vorbereitung und Durchführung von Trainings zum Thema Datenintegrität Bearbeitung von Abweichungen und Änderungsanträgen Erstellung / Review entsprechender SOPs und Begleitdokumentationen Unterstützung bei Audits und Inspektionen, sowie bei deren Vor- und Nachbereitung
Irland | Freiberuflich für ein Projekt | Startdatum: sofort | 398870/1
Leitung der Validierungsbemühungen und Entwicklung der erforderlichen Dokumentation für eigenständige computergestützte Laborgeräte und -software wie Empower, HPLC, UPLC, Spektrophotometer, UV-Vis, FTIR, etc. Unterstützung des Change Managements und Management bestehender Laborsysteme
Stein | Freelance/temporary employment for a project | Startdatum: sofort | 483651/1
Perform batch release for aseptic manufactured drug product produced in internal and external DP sites Write, review and approve deliverables (e.g. procedures, SOPs, cleaning documents, gap assessments) and related tools (e.g. IT, document systems, training tools, facility validation) to ensure GMP compliance Ensure control that the corresponding elements of the GMP Quality Manual are appropriately implemented and followed in Sterile Production Stein and at external manufacturing sites Document Review and approval including documents in electronic systems like MES (e.g. master batch records, executed batch record) Advice line functions concerning product and process related topics Approve change requests, deviation and CAPAs related to product and process Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority guidance, SOPs, HSE, etc.) Promote and enforce compliance to guidelines Support a culture of high performance and trust Assure that the required level of knowledge and skills is available and identify competency gaps Establish and implement training and development plans
Basel region | Freelance/temporary employment for a project | Startdatum: sofort | 474367/1
Write equivalence reports for the customer and CMO testing monographs Responsible for writing and coordinating Agile Change Requests AQWA (track wise) actions/deviations/quality events Ensure that coordinated contact is maintained with other functions within the company also dealing with external suppliers namely Purchasing, Legal, Supply Chain, Regulatory CMC, Drug RegulatoryAffairs, Group Quality Operations Support Launch and transfer Project QAMs regarding interpretation and review of analytical data/reports Participates and/or prepares cGMP audits of external contract laboratories and supplier/CMO laboratories, as required
Solothurn | Freelance/Contracting project | Startdatum: sofort | 410478/29
Design Quality team member focused on life cycle management activities Enhance the Design Control and Risk Management processes to better reflect state of the art practices and drive continuous improvement Apply statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes Perform Gage R&R studies Conduct and lead design verification and validation activities Conduct and lead design / process failure mode effects and analysis Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Complaints, Nonconforming Materials, Risk Management, etc. Provide leadership in the understanding of medical device regulations to other disciplines Communicate effectively at all levels within Quality as well as cross functionally with departments such as Product Development, Regulatory Affairs, Manufacturing, and Marketing Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times Accountable for the successful delivery of multiple simultaneous projects, spanning multiple functional areas and locations Responsible for clear definition of project scope and deliverables, milestones and timeline, project risks and contingency plans

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