Jobdescription
For our Client in Visp we are searching for a
Technical Document Manager who is responsible for coordinating the
creation, adaptation, version control, and approval workflows of
key project documentation throughout all project
phases.
Key Responsibilities:
Responsible for
performance qualification (PQ) from detailed design through
execution. This 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.
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)
Interface
Management: Act as a liaison between internal departments
(production, engineering, QA, validation) and external EPCM
partners for technical documentation
exchange
GMP Change
Documentation: Support the preparation, linkage, and maintenance of
change control documentation
(TCRs/CRs)
Qualifications:
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) with a
detail-oriented and methodical
approach
Fluency in English
(written and spoken); German is an
asset