About The Company
Hubot | Tri Pac, Inc. CDMO is a leading Contract Development and Manufacturing Organization dedicated to supporting the pharmaceutical, personal care, and chemical industries. With a strong emphasis on quality, innovation, and regulatory compliance, Hubot has established itself as a trusted partner for Fortune 500 brands across North America and globally. Our operations are characterized by a commitment to excellence, continuous improvement, and leveraging cutting-edge technologies to deliver high-quality products and services. As a U.S.-based CDMO with a significant presence in India through Hubot India Private Limited, we foster a collaborative environment that bridges geographical and cultural boundaries to achieve shared success.
About The Role
We are seeking a dedicated and experienced Quality Engineer specializing in Quality Systems and eQMS to join our dynamic team remotely from India. This role is integral to driving quality excellence within our organization, supporting U.S. FDA-regulated operations, and ensuring compliance with global standards. The ideal candidate will possess a strong GMP background, a systems-oriented mindset, and hands-on experience in managing and upgrading electronic Quality Management Systems. This position offers an exciting opportunity to contribute directly to our quality infrastructure, lead investigations, and support continuous improvement initiatives that uphold our commitment to regulatory excellence and product integrity.
Qualifications
The successful candidate will have a minimum of 5 years of experience working in a GMP-regulated environment, 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 is essential. Hands-on experience with eQMS platforms like Veeva Vault, MasterControl, TrackWise, or similar systems is required. The candidate should possess a Bachelor's degree in Engineering, Quality, Life Sciences, or a related field. Excellent written and verbal communication skills in English, along with the ability to collaborate effectively across different time zones, are critical for success in this role.
Responsibilities
- Lead failure investigations utilizing root cause analysis tools such as 5-Why, Fishbone diagrams, and FMEA, and oversee CAPA implementation to address quality issues effectively.
- Review Batch Records, Standard Operating Procedures (SOPs), and change controls ensuring GDP compliance and alignment with regulatory standards.
- Assess proposed process and design changes for compliance with change control requirements, guiding qualification and validation activities accordingly.
- Monitor and implement procedures related to quarantine, hold, expired, damaged, return goods, and product recalls to ensure product integrity and regulatory adherence.
- Conduct routine analysis of key performance indicators (KPIs) and quality metrics, identifying trends and presenting insights to U.S. leadership for strategic decision-making.
- Support the updating of risk management files for process modifications, implementing process controls, error-proofing measures, and continuous improvement initiatives.
- Collaborate with process owners and cross-functional teams to provide training, mentorship, and facilitate adherence to QMS requirements.
- Administer and support eQMS modules including CAPA, document control, deviation management, audit management, and training records, ensuring system integrity and compliance.
- Contribute to the upgrade, validation, and ongoing maintenance of the eQMS platform, supporting validation activities and ensuring compliance with 21 CFR Part 11 and audit trail integrity.
- Assist in internal audit preparations and participate in FDA, ISO, and customer audits to demonstrate compliance and continuous readiness.
Benefits
At Hubot India, we offer a competitive package aligned with industry standards, along with opportunities for professional growth and development. Our employees benefit from exposure to international regulatory environments, meaningful ownership of eQMS processes, and a collaborative work culture. We support flexible work arrangements, and our growth trajectory provides a clear pathway for career advancement into senior quality roles. Additionally, our focus on innovation and continuous improvement ensures that team members are always engaged with cutting-edge quality systems and practices, making this a rewarding environment for quality professionals committed to excellence.
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, age, sexual orientation, disability, or any other protected characteristic. Our hiring practices are designed to foster a workplace that values different perspectives and experiences, ensuring that everyone has the opportunity to contribute and succeed.
