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Qa Controlled Docs Associate

Fortrea
Fortrea
6-8 years
Not Disclosed
Bangalore, Mumbai, India
10 Feb. 12, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

QA Controlled Documents Associate – GxP Document Management

Location: Bangalore / Mumbai, India
Company: Fortrea
Employment Type: Full-Time
Job Requisition ID: 26240
Application Deadline: February 13, 2026

Job Overview

Fortrea is seeking an experienced QA Controlled Documents Associate to support quality systems and regulatory compliance within a GxP-regulated environment. This role is responsible for administering controlled documents, ensuring document lifecycle compliance, supporting change control processes, and maintaining regulatory readiness across quality and clinical functions.

The position requires strong expertise in document management systems such as Veeva (Quality & Clinical), attention to detail, and the ability to operate within structured regulatory frameworks.

Experience Required

  • 6–8 years of experience in a regulated environment (GxP roles preferred)

  • Proven experience in document management and quality systems

  • Hands-on experience with Veeva Quality and Clinical modules

  • Experience drafting and managing change controls and deviations

  • Equivalent relevant experience may be considered in lieu of formal educational qualifications

Key Responsibilities

Controlled Document Management

  • Administer and maintain controlled documents to ensure availability and accuracy for end users

  • Manage document lifecycle activities including issuance, revision, archival, and obsolescence

  • Perform quality checks to ensure compliance with SOPs and internal standards

  • Ensure timely escalation and resolution of issues impacting document release

Regulatory Compliance & Quality Assurance

  • Ensure adherence to GxP, Regulatory Compliance (RC), and Quality Assurance (QA) requirements

  • Support audits and inspection readiness by maintaining accurate documentation records

  • Draft and manage change controls and deviations in compliance with regulatory expectations

Process Improvement & Metrics Reporting

  • Track and report document control metrics as required by management

  • Participate in process improvement initiatives and assist in implementation of revised procedures

  • Contribute to continuous improvement of document control systems

Training & Cross-Functional Collaboration

  • Deliver training using developed materials to internal stakeholders

  • Facilitate meetings and coordinate with cross-functional teams

  • Communicate effectively with quality, regulatory, and clinical operations teams

Required Skills & Competencies

  • Strong understanding of GxP compliance requirements

  • Hands-on experience with Veeva Quality and Clinical systems

  • Expertise in drafting change controls and deviations

  • Strong planning, prioritization, and organizational skills

  • High attention to detail and documentation accuracy

  • Strong interpersonal and stakeholder management skills

  • Proficiency in computer systems and departmental tools

  • Ability to consistently deliver high-quality work

Work Environment

  • Role involves extended periods of computer-based work

  • Office-based position with collaborative team interaction

Why Apply for This Role?

This opportunity is ideal for experienced quality professionals seeking to strengthen their career in pharmaceutical and clinical document control within a global regulatory environment. The role offers exposure to structured quality systems, audit management, and enterprise-level document management platforms.