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Qa Controlled Docs Senior Coordinator

Fortrea
Fortrea
3+ years
Not Disclosed
10 Dec. 22, 2025
Job Description
Job Type: Full Time Hybrid Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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 Senior Coordinator | India (Hybrid – Bangalore, Pune, Mumbai)
Employment Type: Full-Time
Remote Type: Hybrid
Application Deadline: 5 Jan 2026
Job Requisition ID: 255584

Company Overview:
Fortrea is a leading global organization committed to delivering high-quality solutions in the pharmaceutical and regulatory sectors. We foster a culture of compliance, quality, and operational excellence, providing employees opportunities to grow while contributing to impactful global projects.

Role Overview:
We are seeking a QA Controlled Documents Senior Coordinator to manage and maintain regulatory-controlled documents in compliance with GXP standards. This role ensures proper document availability, quality control, and regulatory compliance while supporting the implementation of updated processes and procedures. The ideal candidate will have strong analytical skills, attention to detail, and experience in regulated environments.

Key Responsibilities:

  • Administer and manage controlled documents, ensuring availability and accessibility for end users.

  • Monitor and track document metrics as defined by management and report results within required timelines.

  • Implement new or revised processes and procedures related to controlled documentation.

  • Perform quality checks to ensure accuracy, completeness, and compliance of documents.

  • Escalate and manage resolution of issues affecting controlled document release in a timely manner.

  • Ensure adherence to Regulatory Compliance (RC) and Quality Assurance (QA) standards as defined in applicable controlled documents.

  • Complete mandatory trainings according to departmental timelines.

  • Communicate effectively across teams and departments to support quality initiatives.

  • Perform additional duties as assigned by management.

Qualifications and Experience:

  • Minimum 3 years of experience in a regulatory or GXP-compliant environment.

  • Strong knowledge of regulatory standards and controlled document management.

  • Proven ability to plan, prioritize, and organize tasks effectively.

  • High attention to detail with excellent analytical and problem-solving skills.

  • Strong interpersonal skills with the ability to work collaboratively in a team environment.

  • Proficiency in computer systems and departmental tools for document management.

Work Environment:

  • Predominantly office-based with significant computer use.

  • Hybrid work model across Bangalore, Pune, and Mumbai.

  • May require working 2nd shift hours (2 PM – 11 PM IST).

Why Join Fortrea:

  • Work in a global organization emphasizing quality, compliance, and professional development.

  • Contribute to critical regulatory and quality initiatives impacting pharmaceutical operations.

  • Collaborative, inclusive, and supportive work environment.

Application Note:
Apply now to join Fortrea as a QA Controlled Documents Senior Coordinator and contribute to maintaining the highest standards of quality and compliance in a regulated global environment.