Jobsuche und Projektbörse für Fach- und Führungskräfte

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35 Ergebnisse

Quality Assurance Associate (m/w/d)

Freiberuflich/in temporärer Festanstellung für ein Projekt

Bern

Koordination und Untersuchung von Produktreklamationen und Nebenwirkungsmeldungen
Sicherstellung der termin- und qualitätsgerechten Untersuchungen (z.T. standortübergreifend) und Durchführung von CAPA Aktionen
Vorbereitung von Behördenkommunikationen
Zusammenarbeit mit den Produktionsbereichen und anderen Schnittstellen im Unternehmen
Vorbereitung von Behördenaudits / Inspektionen sowie Unterstützung bei der Beantwortung von Behördenanfragen

Online seit: Wed Oct 30 10:54:52 CET 2024

QC Specialist (m/w/d)

Freiberuflich/in temporärer Festanstellung für ein Projekt

Zug

Wareneingangs-, Zwischen-, End- sowie Stabilitätskontrolle von BG/E-Produkten sowie Ausgangsmaterialien, Zwischenprodukten und Endprodukten
Auswertung von Testergebnissen und Dokumentation von Analysenergebnissen
Sicherstellung und Dokumentation entsprechend der GxP Richtlinien
Erstellen von Berichten und allgemeinen Dokumenten
Kommunikation, Interaktion und Zusammenarbeit mit internen Schnittstellen z.B. BG/E Produktion, Quality Assurance, Einkauf, Facility Management
Review von Analyseergebnissen und Testdokumentationen
Durchführung von SAP-Transaktionen
Mitarbeit bei der Labor-Organisation und Planung sowie Aufrechterhaltung der Labor Routine z.B. Bestellung, Reinigung, Wartung
Einführen von Teammitgliedern, Mitarbeit bei der Ausbildung von QC Teammitglieder oder anderer Mitarbeiter in SOPs und Testmethoden, für welche der Mitarbeiter qualifiziert ist
Bereitschaft zur Aushilfe in anderen Abteilungen mit ähnlichem Skillset

Online seit: Tue Oct 08 11:09:05 CEST 2024

CQV Engineer (m/f/d)

Freelance/temporary employment for a project

Visp, Valais

The CQV Engineer will be involved in all validation activities including but not limited to: Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, among others
The validation documentation deliverables include URS, DQ, FMEA, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ). Prepare validation documents
Execution of IQ/OQ and PQ for equipment, systems and utilities
Write reports of completed validation activities
Work to identify efficiencies in the validation program approach
Work to apply lessons learned and stay informed of industry regulatory changes as it applies to equipment / facility validation
Perform assigned Quality Systems activities including Document Management system, Change Control, Non-Conformities, and CAPA’s. Writing and/or revising procedures applicable to the Engineering activities
Support the Engineering group to prepare the validation, requalification, and maintenance program
Perform other duties as assigned

Online seit: Mon Nov 18 10:12:58 CET 2024

Document Controller (m/f/d)

Freelance/temporary employment for a project

Visp, Valais

Review the punch lists for the missing or incorrect documentation for the Vendor Turn-Over Packages
(VTOP) and the Construction Turn-Over Packages (CTOP) and drive the Vendors/Contractors to close the identified issues
Review the punch lists for the missing or incorrect documentation for the Vendor Turn-Over Packages

Online seit: Fri Nov 15 15:37:16 CET 2024

Quality Project Manager (m/f/d)

Freelance/temporary employment for a project

Basel Stadt

Acts as TRD excipient portfolio manager. Interacts and collaborates with internal and external stakeholders, customers and/or suppliers, according to specific area of responsibility
Maintains TRD excipient portfolio regarding supplier approval
Ensures change control management of excipient related matters notified by suppliers or triggered internally. Supports project teams in case of excipient-related request
Handling of change actions and CAPAs, related to excipient involving multiple project users in TRD about supplier or product specifications. Guides project teams through new excipient implementation operations
Acts as line unit representative to TRD Third Party QA organization with respect to TRD excipient portfolio and ensures that own deliverables are met
Acts as line unit representative and SME for interactions within TRD and with NTO excipient counterparts on local sites when needed
Supports PHAD Excipient Supply and Demand planning coordinators. Acts as key expert for new excipient/supplier implementation in TRD portfolio
Coordinates activities linked to transfer of excipient ownership from commercial site back to TRD in case of discontinuation
Maintains effective information channel with all involved parties. Communicates issues to involved partners. Ensures compliance to Company and other relevant regulations
Shows positive work ethics and influences others. Proposes and implements ideas for continuous process improvement also outside area of expertise/ organization.

Online seit: Fri Nov 15 14:22:48 CET 2024

Automation Engineer - HVAC (m/f/d)

Freelance/temporary employment for a project

Stein, Aargau

Provide design support for the generation and configuration of the DeltaV system configuration for the following utility systems which are monitored and controlled by the DeltaV DCS
Heating Ventilation and Air Conditioning for the classified and non-classified areas within the site manufacturing and utility areas
Environmental Monitoring System consisting of room monitoring conditions including differential pressure, humidity and temperature parameters
Air Lock Control Systems for the personal and material air lock controls to the clean rooms in the manufacturing areas
Review and approve Automation Requirements, Design, Test, Qualification and Validation documentation
Provide guidance and technical direction to the external System Integrator for the generation and testing of the DeltaV DCS software configuration
Support software FATs and SATs by approving documents and witnessing on behalf of Lonza as the Lonza Automation Representative
Support the integrated commissioning of the DeltaV system software, hardware and interfaces to the HVAC and associated systems listed above
Support the reliable operation of the HVAC control systems by providing hands on support to trouble shoot control system software and hardware issues
Support the overall Dolphin Project Team to collate supporting information to allow timely decisions to be made that will minimize cost, timeline and quality impact on the Project

Online seit: Mon Nov 11 12:02:20 CET 2024

Site Commissioning Engineer (m/f/d)

Freelance/temporary employment for a project

Stein, Aargau

Check on contractors schedule and track site progress on all systems i.e. Mech, Electrical, HVAC, Automation, CSA
Reporting to the building Technical PM, giving daily updates on status of construction commissioning progress
Support/accompaniment of 3D coordination, resolution of collisions, adjustments, etc.
Supervise contractor walkdowns for systems and utilities.
Track status of Document completion like CTOPs

Online seit: Fri Nov 08 16:31:26 CET 2024

CQV Execution Engineer (m/f/d)

Freelance/temporary employment for a project

Visp, Valais

Includes, but not limited to, execution of the following activities for the relevant systems in accordance with project procedures/guidelines.
System Boundary development and approval
Design Qualification preparation, execution and approval. Includes release for IQ
GMP-RA’s
Commissioning preparation, execution and approval. Includes vendor supervision on their testing scope and quality
Installation Qualification preparation, execution and approval. Includes release for OQ
Operational Qualification preparation, execution and approval. Includes release to OPS
Provide support in execution of Design Qualification for other direct impact systems
Provide support in the implementation of the Installation Commissioning process in accordance with project procedures/guidelines

Online seit: Wed Nov 06 15:35:08 CET 2024

Beginner Engineer (m/f/d)

Freelance/temporary employment for a project

Visp, Valais

Backcheck of the P&IDs returning from the draftsman and visual checks performed by overlaying two consecutive versions of the same P&ID
Minor updates to engineering documentation
Minor field activities related to engineering tasks supporting the construction and qualification activities

Online seit: Wed Nov 06 15:30:50 CET 2024

Specialist Quality Assurance (m/f/d)

Freelance/temporary employment for a project

Lucerne

Review and release of incoming label stock
Review, and release of clinical finished goods, including review of the printed and applied label
GMP review of the batch record and review of the regulatory filings and the final release
Collaborate closely with our internal functional areas (i.e. GMP Manufacturing & Packaging & Logistics, Comparator Planning, Clinical Quality, Clinical Research Associates, Central Complaint Handling Unit, Batch releasing Quality) and external partners (i.e. Contract Manufacturing Organizations,).
Communicate batch related issues to management, EU Qualified Persons and the Swiss Responsible Person (FvP). This job requires a high sense of accuracy and very good time management skills which essential to ensure timely supply of the clinical drugs to patients. Prompt, professional and precise communication to local and global stakeholders is key.
Logbook reviews
Support in Quality Walkdowns, GEMBA walks and/or Walkthrough Audits of GMP areas/on the shop floor to sustain continuous improvements efforts, ensure quality compliance and/or identify potential area of improvements

Online seit: Wed Oct 30 14:12:40 CET 2024

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Batch Record Reviewer (m/f/d)

Freelance/temporary employment for a project

Visp, Valais

Review executed electronic Batch Records, including cleaning logs, production documentation, temperature reports and test procedures
Clarify comments and discrepancies in Batch Records with the operations team and evaluate them with the QA Manager
Initiate and support the investigation of deviations and observations related to Batch Record reviews
Assist in the initiation of Change Requests (CRs) and Temporary Change Requests (TCRs)
Prepare documentation packages to support fast and efficient product release by QA

Online seit: Thu Oct 24 13:31:22 CEST 2024

CSV Engineer (m/f/d)

Freelance/temporary employment for a project

Stein, Aargau

Acting as subject matter expert (SME) on following Lonza CQV / CSV standards
CSV person of contact of the assigned system till the handover to the operation organization
Participate to the system impact assessment as CSV SME
Define with EMR and Package Units vendor the most appropriate design for vertical integration in the Lonza environment
Create the requested CSV documents according Lonza SOP’s and Guidelines
Organize the reviews of the CSV documents till last QA approval
Participate to the FAT & SAT
Create the tests protocols and execute the tests
Close collaboration with CSV Lead or CQV Lead

Online seit: Fri Oct 11 16:39:58 CEST 2024

CQ Documentation Preparation Lead 100% (m/f/d)

Freelance/temporary employment for a project

Valais

Ensure documentation consistency across the CQ group and manage COMOS / KNEAT / DMS interfaces for CQ group
Responsible for documentation management for the project CQV group. Creating templates, first-of-kinds, alignment across group, approval process, retention process, etc.
Coordination of Operational Qualification Protocol preparation and approvals, including release for OQ and PQ
Coordination of GMP regulations and management of the training programme for Commissioning and Qualification activities
Coordination and communication with other resources for Qualification / Documentation Management activities
Self-manage CQ development review / approval activities with respect to COMOS/KNEAT platforms

Online seit: Wed Oct 02 14:31:11 CEST 2024

CQ Lead, Fill & Finish (m/f/d)

Freelance/temporary employment for a project

Aargau

Ensure that CQV activities are executed in accordance with the C&Q Plan and supporting Validation Plans
Overall planning and execution of the commissioning activities related to allocated areas or systems
Leading and coordinating the C&Q execution effort supported by C&Q EPC teams, Engineering, Operations, and external vendors and contractors
Planning and scheduling the commissioning activities according to the C&Q strategy and supporting Validation Plans
Support the updates of Master C&Q Plan and supporting plans during project execution lifecycle
Support development of C&Q schedule by including the activities relevant for the preparation of commissioning test plans and test specifications
Coordinating the planning and scheduling of commissioning activities with the construction interface and with other disciplines (HSE, Automation, Electrical, Instrumentation, Operation and Engineering, etc.)

Online seit: Wed Oct 02 14:15:52 CEST 2024

QA Associate QMS (m/f/d)

Freelance/temporary employment for a project

Basel Stadt

Receives incoming documents e.g. executed batch records, work orders, vendor labels, packaging instructions etc.
Performs documentation in respective tools. Prepares documentation needed for the batch record review e.g. Analysis Reports, Specifications for clinical development, country label approval etc.
Support the timely release of GMP batches of labels, primary packed materials and Investigational Medical Products
Review and approve GMP relevant documents, e.g. work orders, packaging master documents, clinical study labels, Batch record review for both packed material from internal or contractors. Compiles, Notifications of Extension to be issued due to revised expiry dates. GMP relevant documents in own area of responsibility e.g. CoC's, BRR Checklists
Scan, file and archive documents owned by QA e.g. Certificate of Compliance, Batch Record Review Checklists
Write and review procedures and forms related to the QA Batch record Review Process
Contributes to Right First Time performance reports for release of IMPs
Supports and collaborates with QA & GCS Line Unit in process improvements, Quality & Compliance issues and in the use of GMP relevant IT tools and processes
Support the use, improvement, evaluation and implementation of GMP relevant IT tools and processes

Online seit: Mon Aug 26 09:40:22 CEST 2024

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