Amatullah T. Email & Phone Number

Netherlands

•Co-created, improved, and maintained, the electronic Quality Management System (QMS) in accordance with relevant ISO standards.•Creating quality assurance procedures through SOPs and WI (work instructions).•Lead, conducted, and supervised internal audits.•Lead in product and process risk management activities.•Organized and maintained pMDR complaints as well as reporting to competent health authorities.•Collect and compile statistical quality data. •Analysing data to identify areas for improvement in the quality system.•Monitor and drive corrective and preventive actions.•Supporting FCA completion and enforcing quality agreements with suppliers.•Preparing reports to communicate the results of quality activities through KPIs.•Identify training needs and organize training to meet quality standards.•Support on-site audits conducted by external providers.•Evaluate audit findings and ensure appropriate corrective and preventive actions are implemented.•Achieve personal and team objectives as outlined in the departmental plan.•Create and approve Certificates of Quality and Certificates of Analysis.•Approved the release of (reworked) products from the supply chain.

Netherlands

• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).• Reviews manufacturing, environmental monitoring and quality control data for in process and finished products with guidance from senior colleagues.• Contribute to the Quality on the floor processes, including GEMBA walks and maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs), and Kite procedures.• Provides support to deviation lead/coordinators for deviations investigations and corrective and preventive action (CAPA) relating to manufactured products and contributes to the QA review and approval process of deviations and CAPA.• Identifies and reports deviations from approved processes and procedures to senior colleagues.

Princeton, New Jersey, United States

Analyzed the data from the vigilance system to identify trends in emerging areas of concern, driving timely feedback to the business.Responsible for monitoring, analyzing and applying trending methodologies to the vigilance data submitted to Health Authorities (e.g MDRs/MIRs).Compiled, analyzed and required reports of post-production information as part of the vigilance system (PSURs, PMS Reports, as applicable).Identified emerging signals as to the safety and efficacy of our products, and drives inputs into other aspects of the Church & Dwight Quality Management System (QMS) including but not limited to production, risk management, labeling and product development.Functioned as SME (subject matter expert) for vigilance activities during CAPA’s, internal and external audits.

Princeton, New Jersey, United States

Managed the daily review of medical device malfunction complaints, assessing nature of complaints against defined safety decision tree criteria, SOP, WI, and threshold controls.Directed the daily review of reported foreign object complaints. Performed root cause analysis, completed applicable documentation in complaint file, recorded trends and closed investigations.Spearheaded visual inspection of product returns from consumers or customers in order to:○ Evaluate legitimacy of FOB (foreign object) complaints○ Evaluate "known issue" complaints and document complaint files accordingly.Supported the Quality Analyst (QA) Engineer in the completion of MDR investigation reports viasubmitting batch record requests, follow ups, etcEnsured the timely closure of complaint files in accordance with federal regulations including the FDA,Health Canada, EMA, etc.

Princeton, New Jersey, United States

Managed the daily review of medical device malfunction complaints, assessing nature of complaints against defined safety decision tree criteria, SOP, WI, and threshold controls.Directed the daily review of reported foreign object complaints. Performed root cause analysis, completed applicable documentation in complaint file, recorded trends and closed investigations.Spearheaded visual inspection of product returns from consumers or customers in order to:○ Evaluate legitimacy of FOB (foreign object) complaints○ Evaluate "known issue" complaints and document complaint files accordingly.Supported the Quality Analyst (QA) Engineer in the completion of MDR investigation reports viasubmitting batch record requests, follow ups, etcEnsured the timely closure of complaint files in accordance with federal regulations including the FDA,Health Canada, EMA, etc.

Parsippany, New Jersey, United States

Compare data of 600+ accounts to client rule sets to check for deficienciesInitiate and respond to phone calls and emails in order to collect corrected documentation to enter all data from digital documents into the Certus database

Office Of Student Services

Govern projects of the deans of the department from smaller tasks to larger independent projects. Assisting with larger recruiting and community development events outside of the office space that are co-sponsored with up to 27 student organizations, engineering greek life, and honor societies. Conducting clerical work and regulating daily office management as well as training others in these tasks.

Bernardsville, Nj

Performing medical tests in a laboratory environment for use in the treatment and diagnosis of diseases in animals.Preparing vaccines and serums for prevention of diseases, prepare tissue samples, take blood samples, and execute laboratory tests, such as urinalysis and blood counts.cleaning and sterilizing instruments and materials and maintain equipment and machines. caring for and monitoring the condition of animals recovering from surgery and maintaining controlled drug inventory and related logbooks. clerical work on the computer, managing paper files, and customer interaction in-person, on the phone, and through email. I also trained new employees in my position.

Livingsting Dinning Commons

Manages the schedule and work station assignments for over 60 student employees by forecasting the changing flow of patrons and strategically allocating employees accordingly.Worked large scale special events hosted by the dining hall.Organized work schedules of students during shifting schedules due to exams or complications.

Department Of Earth And Planetary Sciences

Documented and compiled digital files and notes from the handwritten field notes for the professors.