Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Position Summary

Become an integral part of the ambitious QA team at Thermo Fisher Scientific Inc. as a Quality Specialist I. This role is pivotal in ensuring our manufacturing processes are of world-class quality and strictly adhere to GMP requirements. Collaborate with a team driven to implement flawless quality systems and successfully meet corporate standards and regulatory compliance.

Responsibilities

Ensure the safety message is lived throughout the organization, promoting a culture of safety.Coordinate document and record management systems; coordinate site document management requirements, including document printing, reconciliation, and archival.Ensure all documents follow approved instructions and that completed records are archived accurately.Coordinate site training and personnel qualification, improving GMP training modules.Ensure timely completion and efficiency checks of CAPAs.Manage corporate standards gap assessment, ensuring site compliance with regulatory requirements.Support and continuously improve the site self-inspection program, including developing annual plans, and performing periodic reviews and trend analyses.Coordinate inspection readiness activities, preparing the site for client and regulatory audits.Participate in audits, ensuring smooth execution and compliance.Adhere to and support the implementation of site data integrity systems.Complete any additional related tasks as assigned.

EHS

Understand and ensure implementation of emergency procedures and safe work systems.Ensure compliance with environmental, health, and safety rules and prompt reporting and investigation of incidents.

Minimum Requirements/Qualifications

Education: Diploma or equivalent experience in Life Sciences, Chemical/Biochemical Engineering, or a related field.Experience: 1-3 years of relevant quality experience in pharmaceuticals preferred. Fresh graduates with relevant qualifications may be considered.Proficiencies: Understanding of cGMP and regulatory compliance, strong communication and collaboration skills, problem-solving capabilities, and knowledge of quality risk management.