Location: Bangalore / Mumbai, India
Job Type: Full-Time
Company: Fortrea
Experience Required: 4–6 Years
Freshers Eligible: No
About the Company
Fortrea is a leading global Contract Research Organization (CRO) delivering clinical development, regulatory, and commercialization solutions to pharmaceutical, biotechnology, and healthcare companies worldwide. The organization is known for driving innovation, maintaining regulatory excellence, and supporting global healthcare advancements through high-quality clinical and quality assurance operations.
Job Overview
Fortrea is hiring an experienced QA Controlled Docs Sr. Coordinator for its Bangalore and Mumbai offices. This opportunity is ideal for professionals with strong expertise in Quality Management Systems (QMS), controlled documentation processes, CAPA management, and regulatory compliance within GxP-regulated environments.
The selected candidate will play a critical role in ensuring accurate document control, compliance management, quality assurance operations, and timely coordination of controlled documentation processes across regulated functions.
Key Responsibilities
Administer and manage controlled documents while ensuring availability and accessibility to end users
Follow departmental Standard Operating Procedures (SOPs) and Work Instructions consistently
Complete mandatory compliance and quality trainings within assigned timelines
Monitor, track, and report departmental metrics as required by management
Support implementation of new and revised quality processes and procedures
Conduct quality checks to maintain accuracy and compliance standards
Ensure timely escalation and resolution of issues affecting controlled document release
Maintain compliance with Regulatory Compliance (RC) and Quality Assurance (QA) guidelines
Collaborate with internal stakeholders to support audit readiness and quality initiatives
Perform additional quality and documentation responsibilities as assigned
Required Qualifications
Bachelor’s Degree in Life Sciences or equivalent industry experience preferred
Strong understanding of Quality Management Systems (QMS) and GxP compliance environments
Hands-on experience with CAPA Management and Veeva Vault
Knowledge of controlled documentation and regulatory processes
Excellent communication, coordination, and organizational skills
Strong analytical mindset with attention to detail
Ability to consistently deliver high-quality work under timelines
Proficiency in computer applications and quality management tools
Preferred Skills
Experience in audit processes and regulatory inspections will be an added advantage
Strong interpersonal and stakeholder management capabilities
Ability to prioritize tasks and manage multiple responsibilities efficiently
Work Environment
Office-based role
5 days working from office, depending on business and line manager requirements
Who Should Apply?
This role is suitable for experienced professionals working in:
Quality Assurance (QA)
Regulatory Affairs
Controlled Documentation Management
Clinical Quality Operations
GxP Compliance
Pharmaceutical Quality Systems
Freshers are not eligible for this position due to the required industry experience in regulated environments.
Why This Opportunity Matters
This is an excellent opportunity for pharmaceutical and life sciences professionals looking to strengthen their career in global quality operations, regulatory compliance, and documentation management within a leading multinational CRO environment.
Apply Now
Candidates interested in advancing their career in Quality Assurance and Regulatory Documentation can apply through the official Fortrea careers portal.
For more verified global pharma, clinical research, pharmacovigilance, regulatory affairs, and biotechnology jobs, visit ThePharmaDaily.com.
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