Overview
Quality Engineer Jobs in India at FetchJobs.co
Title: Quality Engineer
Company: FetchJobs.co
Location: India
About The Company
Hubot | Tri Pac, Inc. CDMO is a renowned Contract Development and Manufacturing Organization (CDMO) dedicated to supporting the pharmaceutical, personal care, and chemical industries. With a strong presence in the United States and a strategic operational hub in India, the company specializes in providing high-quality manufacturing, development, and regulatory support services. Our mission is to deliver excellence in every aspect of product development, ensuring compliance with global standards such as FDA regulations, ISO certifications, and cGMP requirements. Driven by innovation and a commitment to quality, Hubot | Tri Pac, Inc. CDMO aims to be a trusted partner for Fortune 500 brands and emerging companies alike, facilitating their growth and success in competitive markets.
About The Role
We are seeking a dedicated and experienced Quality Engineer to join our remote team in India, supporting our U.S. operations. This role is pivotal in driving quality excellence within our organization, focusing on quality systems, compliance, and continuous improvement initiatives. The ideal candidate will possess a strong GMP background, with hands-on experience managing electronic Quality Management Systems (eQMS) such as Veeva Vault, MasterControl, or TrackWise. You will play a key role in supporting daily quality operations, leading investigations, and contributing to the upgrade and maintenance of our eQMS platform. This position offers an exciting opportunity to work closely with U.S. regulatory and quality leadership, ensuring our processes align with industry standards and regulatory requirements, including 21 CFR Part 11. The role requires overlapping work hours with U.S. Eastern Time, approximately from 5 PM to 10 PM IST, facilitating real-time collaboration across time zones.
Qualifications
The successful candidate will have a minimum of 5 years of experience working in a GMP-regulated environment, preferably within the pharmaceutical, personal care, or chemical manufacturing sectors. A comprehensive understanding of FDA regulations, including 21 CFR 210/211, ISO 9001, ISO 22716, and 21 CFR Part 11, is essential. Hands-on experience with eQMS platforms such as Veeva Vault, MasterControl, or TrackWise is required, demonstrating your ability to manage and optimize quality systems effectively. A bachelor's degree in Engineering, Quality, Life Sciences, or a related field is mandatory. Excellent written and verbal communication skills in English are necessary to collaborate effectively across different time zones and teams. Additionally, strong analytical skills, attention to detail, and a proactive approach to problem-solving are highly valued.
Responsibilities
In this role, you will be responsible for leading failure investigations utilizing root cause analysis tools such as 5-Why, Fishbone diagrams, and FMEA, and implementing CAPA actions to prevent recurrence. You will review Batch Records, Standard Operating Procedures (SOPs), and change controls to ensure they meet Good Documentation Practices (GDP) and align with regulatory standards. Evaluating proposed process and design changes for compliance with change control requirements, guiding qualification, and validation activities will be part of your daily tasks. Monitoring and managing procedures related to quarantine, holds, expired or damaged products, returns, and recalls are critical to maintaining product integrity. You will analyze key performance indicators (KPIs) and quality metrics, identifying trends and presenting insights to U.S. leadership to inform decision-making. Supporting risk management activities, updating process control documentation, and implementing error-proofing measures are essential responsibilities. You will collaborate with process owners to train and mentor staff on QMS requirements and continuous improvement initiatives. Administering and supporting eQMS modules such as CAPA, document control, deviation management, audit management, and training records will be part of your scope. Contributing to eQMS upgrades, validation, and ongoing maintenance, including supporting process, equipment, and method validations, ensures compliance with 21 CFR Part 11 and audit trail integrity. Additionally, you will assist in internal audits and prepare for external audits by the FDA, ISO, and clients, ensuring compliance and readiness at all times.
Benefits
Joining Hubot | Tri Pac, Inc. CDMO offers a competitive and rewarding work environment with numerous benefits. We anticipate a 25-30% year-over-year growth rate through 2030, providing ample opportunities for career advancement. Employees gain direct visibility and interaction with U.S. quality, production, and regulatory leadership, fostering a collaborative and transparent work culture. The role provides meaningful ownership of eQMS platforms, allowing you to influence and improve quality systems actively. There is a clear pathway for progression to senior roles such as Senior Quality Engineer or Quality Systems Lead. Our flexible remote work setup supports work-life balance, and we offer professional development opportunities, training, and a supportive team environment. Additionally, you will be part of a forward-thinking organization committed to innovation, quality, and continuous improvement, with a focus on employee growth 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 characteristic. Our hiring practices are designed to ensure fairness and equal opportunity for all candidates, fostering a workplace where everyone can thrive and contribute to our shared success.
