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 new 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 and deliverables according to regulatory requirements, standard operating procedures and maintain a culture of high customer services.
- Update and maintain internal and external (client) trackers for metrics, perform and document quality checks, as applicable.
- Assist in onboarding, training and mentoring junior staff and perform additional duties as assigned by the manager.
- Maintain training related documentation as per Fortrea and client requirements.
Qualifications (Minimum Required):
- Bachelor’s in pharmacy or related science degree (or equivalent); or advanced degree (e.g., PhD or Masters) with experience of 2-4 years. Fortrea may consider relevant and equivalent experience in lieu of educational requirements.” OR
- Bachelor’s degree from Engineering /B.Tech /Packaging /Polymer /Printing stream or Packaging Postgraduate/Diploma/Certification in Packaging with minimum 2-4 years of experience in Packaging field will be preferred. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.”
- Speaking-English and/or other languages as applicable.
Experience (Minimum Required):
- 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).
- Technical proficiency with Microsoft Office suite of applications/ Document Management and/or publishing tools.
- Good understanding of the pharmaceutical product life cycle and regulatory requirements, GxP and ICH-GCP guidelines desirable.
- Good organizational and time management ability.
- Good analytical capabilities and Customer focus.
- Good review skills and concern for quality..
Preferred Qualifications Include:
- 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
- Bachelor’s degree from Engineering /B.Tech /Packaging /Polymer /Printing stream or Packaging Postgraduate/Diploma/Certification 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.”
- Knowledge of Management Information System (MIS) and electronic data management system (eg: Regulatory Information Management, etc.) system will be preferred.
- Diploma or certification in Regulatory Affairs will be preferred.
- Interpersonal skills, Problem solving, Innovation and Proactive, taking ownership, Precise, Goal oriented.
- Leadership, problem solving, interpersonal skills.
- Excellent analytical skills with the ability to identify process gaps and root causes and develop innovative solutions.
- Ability to work independently, meet tight deadlines, and maintain a positive attitude.
Physical Demands/Work Environment:
- Physical demands: No special factor at this time.
- Work environment: Office environment or remote.
Learn more about our EEO & Accommodations request here.
