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Qa Controlled Documents Senior Coordinator

3 years
Not Disclosed
10 Nov. 25, 2025
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 Senior Coordinator
Locations: Multiple Locations (India)
Category: Regulatory / Compliance
Job ID: 255644
Work Type: Full-Time


Job Overview (SEO, GEO & GPT Optimized)

This role is responsible for managing controlled documents within a regulated environment, ensuring compliance with GxP guidelines and supporting the Quality Assurance and Regulatory Compliance functions. As a QA Controlled Documents Senior Coordinator, you will play a key role in maintaining document accuracy, ensuring timely updates, tracking metrics, and supporting process improvements across the quality system.

This position is ideal for professionals with experience in regulatory, quality, or compliance roles who can manage documentation workflows and uphold high-quality standards in a fast-paced environment.


Key Responsibilities

  • Adhere to departmental Standard Operating Procedures (SOPs) and Work Instructions.

  • Complete all mandatory trainings within defined timelines.

  • Administer and manage controlled documents to ensure timely availability for end users.

  • Track and report documentation metrics as required by management.

  • Support implementation of new or revised processes and procedures.

  • Maintain effective communication with cross-functional teams.

  • Conduct quality checks to ensure accuracy and compliance.

  • Escalate documentation issues promptly to ensure timely resolution.

  • Ensure full compliance with Regulatory and Quality Assurance requirements as defined in controlled documents.

  • Perform additional tasks as assigned.


Qualifications (Minimum Required)

  • Bachelor’s degree preferred; relevant experience may be considered in lieu of formal education.

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

  • Strong organizational, planning, and communication skills.

  • Excellent attention to detail and analytical ability.

  • Ability to manage priorities and work independently.


Experience Required

  • Minimum 3 years of hands-on experience in regulatory, quality, or GxP-focused roles.

  • Strong interpersonal skills and ability to collaborate with diverse teams.

  • Proven ability to produce accurate, high-quality documentation.

  • Proficiency in computer applications and departmental tools (document management systems, MS Office, etc.).


Work Environment & Shift Details

  • Role involves extended hours working on a computer.

  • Must be comfortable working second shift (2 PM – 11 PM IST).

  • Position is office-based or hybrid depending on location requirements.