Document Control Specialist - Clinical Trial Services Location: Pune Maharashtra India

Pune Maharashtra India
Job Type: Regular Full-time
Division: Precision for Medicine
Business Unit: Translational Sciences
Requisition Number: 4724

Position Summary

The Document Control Specialist will be responsible for the maintenance and management of controlled documents and records for Precision for Medicine as well as provide administrative support to the quality assurance team.

Essential duties include but are not limited to:

Quality Assurance, Document Control - General

Facilitate the electronic document control process regarding new or existing Quality System Documents, and other related records, and tracking the status of documents during their life cycle: draft, peer review, approved, effective, retired / obsolete, etc. Work with owners/originators, reviewers and approvers to facilitate document control workflow, ensuring proper document formatting and organization Ensure right-first-time review prior to formal review process, by quality management, to ensure good documentation practices, readability (clear and concise) and compliance with internal standards. This includes reporting gaps to senior management and providing guidance to document owners regarding how to create, remediate or correct documents Assist with Quality Systems Procedure revision as part of an integration process: keeping track of originating procedures and the new / integrated procedures as well as all related documents (manuals, forms, flowcharts) Assign training workflows for new or revised quality system procedures and for new employees Maintain document security Coordinate Periodic Review of Documents to owners Upload existing/new revision documents to the PLN portal or Precision PLN sites

Training

Conduct training for new and existing employees on electronic quality management system.

Audits

Locate, review, submit, and reconcile document/record requests during audits Ensure timely response to documentation requests for audits Prepare welcome packet folders for upcoming audits Update procedure binders for upcoming audits Prepare Dossiers on Employees Training Binders that are selected

Other duties

Other duties as defined by management Qualifications

Minimum Required:

Bachelor’s degree 1-3 years of experience with ISO 9001/13485 standards Working knowledge of quality and documents in a clinical research organization

Other required:

Obtain Document Control certification within first year Ability to meet deadlines and perform administrative functions Microsoft Office suite proficiency Must be a flexible agile team player who can change activities and directions quickly and respond to a variety of assignments and changing business needs. Must be able to read, write, speak, fluently and comprehend the English language

It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

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