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Technical Document Manager
Posted 6 hours 6 minutes ago by Swisslinx
Your Responsibilities
1) 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 recordsexpectations
Facilitate document creation, updates, and controlled revisions with relevant stakeholders(engineering, QA, production, validation, EPCM)
2) Workflow Coordination
Initiate and manage review and approval workflows in document management systems 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
3) 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-relevantchanges
4) GMP Change Documentation
Support the preparation, linkage, and maintenance of change control documentation (TCRs/CRs) withassociated technical documents
Ensure traceability of changes from requirements through qualification
About the customer:For our client, one of a leading pharma company, we are looking for an experienced Technical Document Manager for a year:
Start Date: ASAP
End Date: 1 year, extension possible
Location: Visp
Workload: 100% pensum
Languages: English
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 designthrough execution and performance qualification (PQ). The scope includes both CapEx-driven mechanicaladaptations managed by external engineering (EPCM) partner and OpEx improvements executed by internalproduction teams, all within a regulated GMP framework.
Requirements:Education & Experience
3+ years of experience in a regulated GMP environment, preferably in pharma/biotech
Proven experience in document management or technical documentation within CapEx or OpExprojects
Familiarity with GMP-compliant change management processes (CRs/TCRs)
Degree in Engineering, Life Sciences (preferably biopharmaceuticals), Technical Writing, or related field
Skills & 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 andexternal stakeholders
Fluency in English (written and spoken); German is an asset
Online Application until 1st SEP
If you are ready to make an impact today, we are looking forward to your online application with your latest CV. If your profile is shortlisted, our consultant will contact you for a first call to discuss the details.
jid5b993a1a jit0835a jiy25aSwisslinx
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