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About The Company
Hubot | Tri Pac, Inc. CDMO is a leading Contract Development and Manufacturing Organization dedicated to providing high-quality pharmaceutical, personal care, and chemical products to clients worldwide. With a strong focus on innovation, compliance, and operational excellence, Hubot operates as a trusted partner for Fortune 500 brands and emerging companies alike. Our global footprint spans North America and India, enabling us to leverage diverse expertise and state-of-the-art facilities to meet the evolving needs of the life sciences industry. At Hubot, we are committed to fostering a collaborative and inclusive work environment that promotes continuous improvement, scientific rigor, and regulatory compliance.
About The Role
The Quality Engineer — Quality Systems & eQMS role is a pivotal position within our India-based team, supporting our U.S. operations. This remote opportunity is ideal for a seasoned quality professional with a strong GMP background and a systems-oriented mindset. The successful candidate will be responsible for managing and enhancing our quality management systems, leading investigations, and ensuring compliance with regulatory standards such as FDA, ISO, and other global guidelines. You will play a critical role in our eQMS upgrade and maintenance, ensuring the integrity and audit readiness of our quality documentation and processes. This role offers a unique opportunity to contribute directly to the quality excellence of a high-growth CDMO, supporting critical operations that impact patient safety and product efficacy.
Qualifications
The ideal candidate will possess a minimum of 5 years of experience working within GMP-regulated environments, such as pharmaceuticals, personal care, or chemical manufacturing. 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 electronic Quality Management System platforms like Veeva Vault, MasterControl, or TrackWise is required. Strong communication skills in English, both written and verbal, are necessary to facilitate effective collaboration across time zones. A bachelor's degree in Engineering, Quality, Life Sciences, or a related field is mandatory, with additional certifications in quality management or regulatory affairs considered a plus.
Responsibilities
- Lead failure investigations using root cause analysis tools such as 5-Why, Fishbone diagrams, and FMEA, and drive the implementation of corrective and preventive actions (CAPA).
- 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 for compliance with change control requirements, guiding qualification and validation activities.
- Monitor and manage procedures related to quarantine, holds, expired products, damages, returns, and recalls to ensure product integrity and regulatory compliance.
- Conduct routine analysis of key performance indicators (KPIs) and quality metrics, identify trends, and present actionable insights to U.S. leadership for continuous improvement.
- Support updates to risk management files for process modifications, implementing process controls and error-proofing measures to mitigate risks.
- Collaborate with process owners to provide training, mentorship, and support in QMS requirements, fostering a culture of quality and continuous improvement.
- Administer and support eQMS modules, including CAPA, document control, deviation management, audit management, and training records.
- Participate in eQMS upgrades, validation, and ongoing maintenance activities, ensuring compliance with 21 CFR Part 11 and maintaining audit trail integrity.
- Assist in internal audits and prepare for external audits by the FDA, ISO, and customers, ensuring readiness and compliance across all quality systems.
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 benefit from a dynamic work environment that encourages innovation and learning. We provide opportunities for career advancement, including clear pathways to senior roles such as Quality Systems Lead or Senior Quality Engineer. Our flexible work arrangements and support for remote work enable a healthy work-life balance. Additionally, we offer health insurance options, professional development programs, and a collaborative team culture committed to excellence and integrity.
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 characteristic. All qualified applicants will receive consideration for employment without regard to these factors. We believe that a diverse workforce enhances our ability to innovate and serve our clients effectively, and we are dedicated to fostering a workplace where everyone can thrive and contribute to our collective success.
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