Job Description
About The Company
Hubot | Tri Pac, Inc. CDMO is a leading Contract Development and Manufacturing Organization specializing in pharmaceutical, personal care, and chemical products. With a strong commitment to quality, innovation, and customer satisfaction, Hubot operates across multiple regions, including the United States and India. Our global presence enables us to provide comprehensive solutions that meet stringent regulatory standards and cater to Fortune 500 clients. Through our dedicated teams and advanced facilities, we strive to deliver excellence in every aspect of product development, manufacturing, and quality assurance.
About The Role
We are seeking a highly skilled and motivated Quality Engineer to join our team remotely from India. This role is pivotal in ensuring the integrity and compliance of our quality systems, particularly focusing on the electronic Quality Management System (eQMS). The ideal candidate will have a strong background in GMP regulations, quality assurance processes, and systems management. You will work closely with our U.S.-based teams to support daily quality operations, lead investigations, and contribute to the ongoing upgrade and maintenance of our eQMS platform. This position offers a unique opportunity to influence quality practices in a fast-growing, FDA-regulated environment, with significant interaction across international teams and regulatory bodies.
Qualifications
The successful candidate will possess a minimum of 5 years of experience working within GMP-regulated environments, such as pharmaceutical, personal care, or chemical manufacturing sectors. A thorough understanding of FDA regulations (21 CFR 210/211), ISO standards (ISO 9001, ISO 22716), and 21 CFR Part 11 compliance is essential. Hands-on experience with eQMS platforms like Veeva Vault, MasterControl, or TrackWise is highly desirable. The candidate should have a Bachelor's degree in Engineering, Life Sciences, Quality, or a related field. Excellent communication skills in English, both written and verbal, are necessary to facilitate effective collaboration across time zones. A proactive approach to problem-solving and continuous improvement is also important.
Responsibilities
The core responsibilities of this role include leading failure investigations utilizing root cause analysis tools such as 5-Why, Fishbone, and FMEA, and implementing Corrective and Preventive Actions (CAPA). You will review batch records, Standard Operating Procedures (SOPs), and change controls to ensure compliance with Good Documentation Practices (GDP) and regulatory requirements. Evaluating proposed process and design changes for change control adherence, guiding qualification and validation activities, and supporting risk management updates are also key duties. Monitoring procedures related to quarantine, holds, expired or damaged products, and recalls ensures product integrity and compliance. You will analyze key performance indicators (KPIs) and quality metrics, identify trends, and communicate findings to U.S. leadership for strategic decision-making.
Additionally, you will support the implementation of process controls, error-proofing measures, and facilitate training and mentorship for functional process owners. Administer and support various eQMS modules such as CAPA, document control, deviation management, audit management, and training records. Contributing to eQMS upgrades, validation activities, and ongoing maintenance ensures system integrity and compliance with 21 CFR Part 11. You will also assist in internal audits and prepare for FDA, ISO, and customer audits, ensuring readiness and adherence to regulatory standards.
Benefits
Joining Hubot | Tri Pac, Inc. CDMO offers a dynamic and growth-oriented environment with opportunities for professional development and advancement. We provide a competitive salary package, comprehensive health benefits, and flexible work arrangements to support work-life balance. Our organization fosters a culture of innovation, collaboration, and continuous learning. Employees gain exposure to cutting-edge quality systems and processes, with clear pathways to senior roles such as Quality Systems Lead or Senior Quality Engineer. We also emphasize transparency, recognition, and a supportive work environment that values diversity and inclusion.
Equal Opportunity
Hubot | Tri Pac, Inc. CDMO is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based on race, religion, gender, sexual orientation, age, disability, or any other protected status. We believe that diverse teams foster innovation and drive our success, and we are dedicated to providing equal employment opportunities to all qualified candidates.
