Job Position – Document Controller Specialists

Company Name – Indegene

Job Description

For medical device domain who can join us within 60 days.
Experience required: 2-4 yrs.

Responsibilities:
· Serves as primary Document Control/EDMS administrator
· Works independently to manage and administer effective Document Control systems ensuring compliance with applicable internal procedures, cGMPs, and regulatory requirements
· Works with QA Director to establish and execute Document Control Procedures
· Supports review, update, filing, and distribution of controlled documents, including standard operating procedures, standard test methods, protocols, summary reports, and technical documents according to specific DCO format standards and guidelines
· Ensures controlled documents conform with applicable procedures and are maintained to the latest revisions, reviews formats for consistency
· Coordinates the approval process and orderly upload and filing of controlled documents to SharePoint
· Manages Biennial Review and Document Change Control Programs
· Performs proofreading, editing, word processing, and filing to support the Quality Assurance, Documentation, Batch Record, and Audit/Inspection functions
· Creates and maintains filing systems (electronic and paper) for all controlled documents
· Organizes and maintains QA Document Room and Batch Release documentation relative to projects
· Maintains Deviation, CAPA, and Change Control database/records, SOP Master List, and document number issuance logs for controlled documents

Email : nivedita.patra@indegene.com