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  • Technical Document Manager (6636) - Valais - CTC Resourcing Solutions

    CTC Resourcing Solutions
    CTC Resourcing Solutions Valais

    vor 2 Monaten

    CHF120,000 - CHF180,000 (CHF) pro Jahr *
    Beschreibung

    Technical Document Manager – 6636
    Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a
    Technical Document Manager
    for an potential project starting next month, for a
    contract role of 1 year (with potential extension),
    based in the
    Visp
    , Switzerland.

    The Technical Document Manager is responsible for coordinating the creation, adaptation, version control, and approval workflows of key project documentation throughout all project phases – from detailed design through execution and performance qualification (PQ). The scope includes both CapEx-driven mechanical adaptations managed by external engineering (EPCM) partner and OpEx improvements executed by internal production teams, all within a regulated GMP framework.

    Main Responsibilities
    Document Control & Lifecycle Management

    • Own the end-to-end lifecycle of technical project documents including, but not limited to:

    – URS (User Requirement Specifications)

    – TS (Technical Specifications)

    – FDS (Functional Design Specifications)o P&IDs (Piping and Instrumentation Diagrams)

    – Drawings, datasheets, design reviews, and vendor documentation

    • Ensure compliance with internal documentation standards, GMP requirements, and quality records expectations
    • Facilitate document creation, updates, and controlled revisions with relevant stakeholders(engineering, QA, production, validation, EPCM)

    Workflow Coordination

    • Initiate and manage review and approval workflows in document management systems (e.g. Documentum (DMS) or equivalent)
    • Track and follow up on sign-offs and ensure timely completion of review cycles
    • Ensure document traceability and audit readiness across all phases of the project

    Interface Management

    • Act as a liaison between internal departments (production, engineering, QA, validation) and externalEPCM partners for technical documentation exchange
    • Coordinate handover and archiving of EPCM-generated documents into internal systems
    • Support alignment between CapEx documentation and OpEx procedural updates or GMP-relevant changes

    GMP Change Documentation

    • Support the preparation, linkage, and maintenance of change control documentation (TCRs/CRs) with associated technical documents
    • Ensure traceability of changes from requirements through qualification

    Qualifications And Experience

    • Relevant working/residency permit or Swiss/EU-Citizenship required
    • Degree in Engineering, Life Sciences (preferably biopharmaceuticals), Technical Writing, or related field
    • 3+ years of experience in a regulated GMP environment, preferably in pharma/biotech
    • Proven experience in document management or technical documentation within CapEx or OpEx projects
    • Familiarity with GMP-compliant change management processes (CRs/TCRs)

    Key Competencies

    • Strong knowledge of technical documentation and engineering terminology (URS, P&ID, FDS, etc.)
    • Experience with electronic document management systems (EDMS)
    • Excellent organizational and coordination skills
    • Detail-oriented and methodical approach
    • Strong interpersonal communication skills; ability to manage interfaces between departments and external stakeholders
    • Fluency in English (written and spoken); German is an asset
    * Diese Gehaltsspanne ist eine Schätzung von beBee
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Technical document manager