Job Overview:
• Responsible for responsible for managing laboratory instruments, ensuring compliance with regulatory standards, and supporting quality and validation activities in a cGMP environment.

Summary of Responsibilities:
• Manage the entire lifecycle of laboratory instruments, including installation, qualification, and maintenance.
• Oversee the qualification process of recent instruments and software, ensuring compliance with internal and external standards.
• Prepare and review SOPs, protocols, validation master plans, and other cGMP documentation.
• Handle nonconformance reports, initiate change controls, and implement corrective and preventive actions.
• Assist in driving digital transformation initiatives within equipment lifecycle management activities
• Maintain and update relevant documentation such as VMP, MMP, eCMMS Assets, and Preventive Maintenance schedules.
• Conduct data integrity assessments of computerized systems.
• Evaluate instrument specifications against USP/EP standards for compliance.




• Assist in implementing systems that meet applicable regulatory requirements.
• Issue laboratory notebooks and coordinate timely reviews of SOPs and WI.
• Support internal and external audits for the department.
• Provide support to ECLs in all activities related to equipment lifecycle management.
• Escalate the potential issues and serve as analytical strategist and coordinator across the product development stages and post approval maintenance, as applicable.
• Management, review and submission of Import/Export Licenses, Dual Use NOC’s and Import Certificates. Responsible for license applications, license availability, debiting and reconciliation, as applicable.
• Seek guidance from other team members and manager as needed and keep up to date knowledge of various regulatory guidelines required for pharmaceutical product registration and product life cycle maintenance.
• Implement the use of consistent, efficient and quality processes to meet timelines a

📌 Regulatory Operations Specialist I (Mumbai)
🏢 Fortrea
📍 Mumbai