<p><b><span class="emphasis-2">Job Overview:</span></b></p><p><span>Responsible for responsible for managing laboratory instruments, ensuring compliance with regulatory standards, and supporting quality and validation activities in a cGMP environment.</span></p><ul></ul><p></p><p><b><span class="emphasis-2">Summary of Responsibilities:</span></b></p><ul><li>Manage the entire lifecycle of laboratory instruments, including installation, qualification, and maintenance.</li><li>Oversee the qualification process of new instruments and software, ensuring compliance with internal and external standards.</li><li>Prepare and review SOPs, protocols, validation master plans, and other cGMP documentation.</li><li>Handle nonconformance reports, initiate change controls, and implement corrective and preventive actions.</li><li>Assist in driving digital transformation initiatives within equipment lifecycle management activities</li><li>Maintain and update relevant documentation such as VMP, MMP, eCMMS Assets, and Preventive Maintenance schedules.</li><li>Conduct data integrity assessments of computerized systems.</li><li>Evaluate instrument specifications against USP/EP standards for compliance.</li><li>Assist in implementing systems that meet applicable regulatory requirements.</li><li>Issue laboratory notebooks and coordinate timely reviews of SOPs and WI.</li><li>Support internal and external audits for the department.</li><li>Provide support to ECLs in all activities related to equipment lifecycle management.</li><li>Escalate the potential issues and serve as analytical strategist and coordinator across the product development stages and post approval maintenance, as applicable.</li><li>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.</li><li>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.</li><li>Implement the use of consistent, efficient and quality processes to meet timelines and deliverables according to regulatory requirements, standard operating procedures and maintain a culture of high customer services.</li><li>Update and maintain internal and external (client) trackers for metrics, perform and document quality checks, as applicable.</li><li>Assist in onboarding, training and mentoring junior staff and perform additional duties as assigned by the manager.</li><li>Maintain training related documentation as per Fortrea and client requirements.</li></ul><p></p><p><b><span class="emphasis-2">Qualifications (Minimum Required):</span></b></p><ul><li>Bachelor’s in pharmacy or related science degree (or equivalent); or advanced degree (e.g., PhD or Masters) with experience of 4-7 years. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.” OR</li><li>Bachelor’s degree from Engineering /B.Tech /Packaging /Polymer /Printing stream or Packaging <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">Postgraduate/Diploma/Certification</span> with minimum 4-7 years of experience in packaging field will be preferred. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.”</li><li>Speaking-English and/or other languages as applicable.</li></ul><p></p><p><b><span class="emphasis-2">Experience (Minimum Required):</span></b></p><ul><li>At least 4-7 Years of experience in the job discipline (e.g. Regulatory Affairs/ Quality Assurance/Analytical science / Packaging, polymer and/or printing stream / pharmaceutics / material management and overall drug development and manufacturing process).</li><li>Technical proficiency with Microsoft Office suite of applications/ Document Management and/or publishing tools.</li><li>Good understanding of the pharmaceutical product life cycle and regulatory requirements, GxP and ICH-GCP guidelines desirable.</li><li>Good organizational and time management ability.</li><li>Good analytical capabilities and Customer focus.</li><li>Good review skills and concern for quality.</li></ul><p></p><p><b><span class="emphasis-2">Preferred Qualifications Include:</span></b></p><ul><li>Bachelor’s in pharmacy or related science degree (or equivalent); or advanced degree (e.g., PhD or Masters) with experience of 4-7 years. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.” OR</li><li>Bachelor’s degree from Engineering /B.Tech /Packaging /Polymer /Printing stream or Packaging <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">Postgraduate/Diploma/Certification</span> with minimum 4-7 years of experience in packaging field will be preferred. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.”</li><li>Knowledge of Management Information System (MIS) and electronic data management system (eg: Regulatory Information Management, etc.) system will be preferred.</li><li>Diploma or certification in Regulatory Affairs will be preferred.</li><li>Interpersonal skills, Problem solving, Innovation and Proactive, taking ownership, Precise, Goal oriented.</li><li>Leadership, problem solving, interpersonal skills.</li><li>Excellent analytical skills with the ability to identify process gaps and root causes and develop innovative solutions.</li><li>Ability to work independently, meet tight deadlines, and maintain a positive attitude.</li></ul><p></p><p><b><span class="emphasis-2">Physical Demands/Work Environment:</span></b></p><ul><li>Physical demands: Available to travel as per business requirement.</li><li>Work environment: Office environment or remote.</li></ul><p></p><p><span>Learn more about our </span><a href="https://careers.fortrea.com/us/en/eeo-and-accommodations" target="_blank" rel="noopener noreferrer">EEO & Accommodations request here</a><span>.</span></p>