Proclinical is seeking a Technical Document Manager to support the coordination and management of technical project documentation within a regulated GMP framework. This role involves overseeing the lifecycle of key documents, ensuring compliance with internal standards, and facilitating workflows across various project phases. You will act as a central point of contact between internal teams and external partners, ensuring seamless documentation processes for both CapEx and OpEx projects.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
1. Manage the end-to-end lifecycle of technical project documents, including User Requirement Specifications (URS), Technical Specifications (TS), Functional Design Specifications (FDS), Piping and Instrumentation Diagrams (P&IDs), drawings, datasheets, and vendor documentation.
2. Ensure compliance with GMP requirements, internal documentation standards, and quality records expectations.
3. Facilitate document creation, updates, and controlled revisions in collaboration with engineering, QA, production, validation, and EPCM teams.
4. Initiate and manage review and approval workflows using document management systems (e.g., Documentum DMS or equivalent).
5. Track and follow up on sign-offs to ensure timely completion of review cycles.
6. Maintain document traceability and audit readiness throughout all project phases.
7. Act as a liaison between internal departments and external EPCM partners for technical documentation exchange.
8. Coordinate the handover and archiving of EPCM-generated documents into internal systems.
9. Support alignment between CapEx documentation and OpEx procedural updates or GMP-relevant changes.
10. Assist in preparing and maintaining GMP change control documentation (e.g., TCRs, CRs) and ensure traceability of changes from requirements through qualification.
Key Skills and Requirements:
11. Background in Engineering, Life Sciences, Technical Writing, or a related field.
12. Experience in a regulated GMP environment, preferably within the pharmaceutical or biotech industry.
13. Proven expertise in document management or technical documentation for CapEx or OpEx projects.
14. Familiarity with GMP-compliant change management processes (e.g., CRs, TCRs).
15. Strong knowledge of technical documentation and engineering terminology (e.g., URS, P&ID, FDS).
16. Proficiency with electronic document management systems (EDMS).
17. Excellent organizational and coordination skills with a detail-oriented approach.
18. Strong interpersonal and communication skills to manage interfaces between departments and external stakeholders.
19. Fluency in English (written and spoken); German is an asset.