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- Own the end-to-end lifecycle of technical project documents including, but not limited to:
- 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)
- 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
- 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
- Support the preparation, linkage, and maintenance of change control documentation (TCRs/CRs) with associated technical documents
- Ensure traceability of changes from requirements through qualification
- 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)
- 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
Technical Document Manager (6636) - Valais - CTC Resourcing Solutions
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
– 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
Workflow Coordination
Interface Management
GMP Change Documentation
Qualifications And Experience
Key Competencies
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Technical Document Manager
Nur für registrierte Mitglieder Visp
-
Technical Package Lead – 6612 (6612)
Nur für registrierte Mitglieder Valais
-
CQV Engineer
Nur für registrierte Mitglieder Visp, Valais
-
Commissioning Qualification Validation Engineer
Nur für registrierte Mitglieder Visp, Valais
-
Quality Assurance Specialist I
Ganztags Nur für registrierte Mitglieder Visp
-
Senior Qualifying Specialist
Nur für registrierte Mitglieder Visp, Valais
-
Bioprocess Engineer – Biologics (6706)
Nur für registrierte Mitglieder Valais
-
Senior QA Specialist, Customer Audit Management 80-100 (f/m/d)
Nur für registrierte Mitglieder Visp, VS
-
Project Assistant
Nur für registrierte Mitglieder Visp
-
Bioprocess Engineer
Nur für registrierte Mitglieder Visp, Valais
-
Senior Qualifying Specialist
Nur für registrierte Mitglieder Visp, Valais
-
Commissioning, Qualification
Nur für registrierte Mitglieder Visp, Valais
-
Process Engineer
Nur für registrierte Mitglieder Visp, Valais
-
Qualification Engineer
Nur für registrierte Mitglieder Valais
-
Purchase Controller
Nur für registrierte Mitglieder Valais
-
CQV Engineer
Nur für registrierte Mitglieder Visp, Valais
-
Administrative CapEx Project Assistant
Nur für registrierte Mitglieder Visp
-
Senior Engineering Project Manager
Nur für registrierte Mitglieder Visp, Valais
-
Senior Bioprocess Engineer
Nur für registrierte Mitglieder Visp
-
Project Assistant
Nur für registrierte Mitglieder Visp
-
IT Infrastructure Lead Switzerland
Nur für registrierte Mitglieder Visp, VS