QA Controlled Documents Associate
Job ID: 26240
Location: Bangalore, India | Mumbai, India
Employment Type: Full-Time
Work Mode: Onsite / Hybrid (as per business requirements)
Application Deadline: February 13, 2026
Job Overview
The QA Controlled Documents Associate plays a critical role in ensuring document control, regulatory compliance, and quality assurance within a GxP-regulated environment. This position supports quality systems by administering controlled documents, maintaining compliance with internal SOPs, and enabling efficient access to accurate documentation for end users across the organization.
This role is ideal for experienced quality professionals with strong expertise in document management systems, regulatory standards, and continuous process improvement.
Key Responsibilities
Adhere strictly to departmental Standard Operating Procedures (SOPs) and Work Instructions.
Complete all required trainings within defined timelines.
Administer and maintain controlled documents, ensuring accurate version control and timely availability.
Track, analyze, and report quality and compliance metrics as defined by management.
Support and participate in process improvement initiatives, including implementation of new or revised procedures.
Train team members using approved training materials and documented processes.
Perform quality checks to ensure accuracy, completeness, and compliance of controlled documents.
Proactively identify, escalate, and support resolution of issues impacting document release timelines.
Ensure compliance with Regulatory Compliance (RC) and Quality Assurance (QA) requirements as defined in controlled documents.
Support audits, inspections, and internal quality reviews as required.
Perform additional duties aligned with quality operations as assigned.
Required Qualifications
6–8 years of experience in a regulated pharmaceutical, biotech, or CRO environment with exposure to GxP quality systems.
Relevant professional experience may be considered in lieu of formal educational requirements, as per company policy.
Required Experience & Skills
Hands-on experience with Veeva Vault (Quality and Clinical modules).
Strong knowledge of document management and document control processes.
Experience in drafting and managing change controls, deviations, and quality records.
Solid understanding of regulatory and quality compliance frameworks.
Excellent planning, prioritization, and organizational skills.
High attention to detail with the ability to deliver consistent, high-quality work.
Strong written and verbal communication skills.
Proven ability to collaborate effectively across cross-functional teams.
Comfortable using computerized systems and quality management tools.
Ability to facilitate meetings and contribute to continuous improvement initiatives.
Work Environment & Physical Requirements
Office-based or hybrid work environment.
Role involves extended periods of working at a computer workstation during standard business hours.
Equal Opportunity Statement
The organization is an equal opportunity employer and is committed to providing reasonable accommodations to qualified individuals with disabilities in accordance with applicable laws and regulations.
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