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About The Company
Hubot | Tri Pac, Inc. CDMO is a leading Contract Development and Manufacturing Organization (CDMO) dedicated to serving the pharmaceutical, personal care, and chemical industries. With a strong focus on quality, innovation, and regulatory compliance, Hubot has established itself as a trusted partner for Fortune 500 brands across North America and globally. The company operates with a commitment to excellence, leveraging cutting-edge technologies and a customer-centric approach to deliver high-quality products and solutions. Through its strategic presence in India, Hubot aims to build a robust quality management system that aligns seamlessly with international standards and supports its U.S. operations effectively.
About The Role
The Quality Engineer — Quality Systems & eQMS role is a vital position within Hubot’s quality team, supporting U.S. FDA-regulated operations remotely from India. This role is designed for a professional with extensive GMP expertise and a systems mindset, responsible for managing daily quality operations, leading investigations, and contributing significantly to the upgrade, maintenance, and administration of the electronic Quality Management System (eQMS). The successful candidate will work closely with U.S. quality, regulatory, and operational teams, ensuring compliance with global standards such as 21 CFR Part 11, ISO 9001, and ISO 22716. This position offers an excellent opportunity to drive quality excellence, influence continuous improvement initiatives, and support regulatory audits, all while working within a dynamic and growth-oriented environment.
Qualifications
- Minimum of 5 years of experience in a GMP-regulated environment, preferably within pharmaceutical, personal care, or chemical manufacturing sectors.
- In-depth knowledge of FDA regulations (21 CFR 210/211), ISO standards (ISO 9001, ISO 22716), and 21 CFR Part 11 compliance requirements.
- Hands-on experience with electronic Quality Management System platforms such as Veeva Vault, MasterControl, TrackWise, or similar systems.
- Strong proficiency in written and spoken English, with the ability to collaborate effectively across different time zones.
- Bachelor’s degree in Engineering, Quality, Life Sciences, or a related field.
Responsibilities
- Lead and facilitate failure investigations utilizing root cause analysis tools such as 5-Why, Fishbone diagrams, and FMEA, ensuring timely CAPA implementation to address quality issues.
- Review batch records, Standard Operating Procedures (SOPs), and change controls to ensure Good Documentation Practices (GDP) compliance and regulatory alignment.
- Assess proposed process and design changes, guiding qualification and validation activities while ensuring adherence to change control requirements.
- Monitor procedures related to quarantine, hold, expired, damaged, return goods, and recalls, ensuring proper management and documentation.
- Conduct routine analysis of key performance indicators (KPIs) and quality metrics; identify trends, prepare reports, and present findings to U.S. leadership for informed decision-making.
- Support risk management activities by updating and maintaining process risk files, implementing process controls, and error-proofing measures to prevent recurring issues.
- Collaborate with process owners and cross-functional teams to provide training, mentorship, and support for QMS requirements and continuous improvement initiatives.
- Administer and support various eQMS modules, including CAPA, document control, deviation management, audit management, and training records, ensuring system integrity and compliance.
- Participate in eQMS upgrades, validation processes, and ongoing maintenance activities; support validation of processes, equipment, and methods to ensure compliance with regulatory standards, including 21 CFR Part 11.
- Assist in internal audit programs and prepare for external audits conducted by FDA, ISO, and customers, ensuring readiness and compliance at all times.
Benefits
Joining Hubot | Tri Pac, Inc. CDMO offers a competitive and comprehensive benefits package designed to support your professional growth and personal well-being. Employees gain the opportunity to work in a rapidly growing organization with a clear career progression pathway, including potential advancement to roles such as Senior Quality Engineer or Quality Systems Lead. The company emphasizes a collaborative and innovative work environment, with exposure to international standards and direct interaction with U.S. quality and regulatory teams. Additionally, Hubot provides flexible remote working arrangements, ongoing training programs, and a culture that values diversity, inclusion, and continuous learning. Employees also benefit from performance-based incentives, health benefits, and a supportive work-life balance aimed at fostering long-term engagement and success.
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. Our recruitment and employment practices are designed to ensure fairness and equal opportunity for all qualified candidates. We believe that diverse teams foster innovation, enhance problem-solving, and drive better business outcomes, and we are dedicated to maintaining a workplace where everyone feels valued and respected.
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