Job Description
BCforward is seeking a highly motivated CSV Technical Writer/Document Controller to support their pharmaceutical client’s Manufacturing facility in Lebanon.
Expected Duration: Long Term
Location: Lebanon, IN/Indianapolis, IN
The CSV Technical Writer/Document Controllers are expected to:
- Deliver New System Validation documents
- Read and understand Validation Plan and Test Plan.
- Support validation efforts as per Validation Plan and Computer System Validation (CSV) document management plan expectations.
- Manage CSV Documentation.
- Assist with the directed drafts and updates of validation deliverables.
- Create and maintain area/project style template.
- Update and maintain validation deliverable templates.
- Ensure document updates align with project style template.
- Ensure documents align with deliverable template.
- Route validation artifacts for review and approval in the electronic document management system, incorporating review feedback.
- Ensure all naming conventions and metadata align with document management plan.
- Route testing artifacts for review and approval in the test management system, incorporating review feedback.
- Apply available views, reports, and queries to support project tracking.
- Communicates document review/approval status.
- Collaborate with Validation Lead to update custom test content in the electronic test system.
- Assemble test sets in the electronic test system.
- Assist SMEs with editing issues in Microsoft Office.
- Assist with updating of spreadsheets, lists, and SharePoint sites as directed.
- Maintain Validated State of Systems
- Support routing and applications for System Access.
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