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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 focus on quality, innovation, and regulatory compliance, Hubot has established itself as a trusted partner for Fortune 500 companies across North America and globally. Our commitment to excellence is reflected in our state-of-the-art facilities, skilled workforce, and dedication to continuous improvement. Operating with a global footprint, we leverage advanced technologies and a customer-centric approach to deliver high-quality solutions that meet the stringent requirements of the industry.
About The Role
We are seeking a highly motivated and experienced Quality Engineer to join our team remotely from India. This role is pivotal in driving quality excellence within our U.S.-regulated manufacturing environment. The ideal candidate will possess a strong background in GMP compliance, quality systems, and experience working with electronic Quality Management Systems (eQMS). You will be responsible for supporting daily quality operations, leading investigations, and contributing to the upgrade and maintenance of our eQMS platform. This position offers an excellent opportunity to work closely with U.S. quality, regulatory, and operational teams, ensuring our processes adhere to global standards and regulatory requirements such as FDA 21 CFR Part 11, ISO 9001, and ISO 22716.
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 strong understanding of FDA regulations, ISO standards, and quality management principles is essential. Hands-on experience with eQMS platforms such as Veeva Vault, MasterControl, or TrackWise is required. Candidates should possess a BA/BS degree in Engineering, Quality, Life Sciences, or a related field. Excellent written and verbal communication skills in English are necessary, along with the ability to collaborate effectively across different time zones. A proactive attitude, attention to detail, and problem-solving skills 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 drive the implementation of Corrective and Preventive Actions (CAPA).
- Review and approve Batch Records, Standard Operating Procedures (SOPs), and change controls to ensure Good Documentation Practice (GDP) compliance and regulatory alignment.
- Assess proposed process and design changes, ensuring they meet change control requirements, and guide qualification and validation activities.
- Monitor procedures related to quarantine, hold, expired, damaged, returned, and recalled products, ensuring compliance and traceability.
- Analyze key performance indicators (KPIs) and quality metrics regularly, identify trends, and present findings to U.S. leadership for continuous improvement.
- Support updates to risk management files for process modifications and implement process controls, error-proofing measures, and validation protocols.
- Collaborate with functional process owners to provide training, mentorship, and ensure adherence to QMS requirements, fostering a culture of continuous improvement.
- Administer and support various 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 regulatory agencies such as FDA and ISO, ensuring readiness and compliance.
Benefits
Joining Hubot | Tri Pac, Inc. CDMO offers a dynamic and growth-oriented environment. We provide competitive compensation packages, comprehensive health benefits, and opportunities for professional development. Our flexible remote work setup allows you to balance your personal and professional life while contributing to impactful projects. Additionally, you will be part of a global team that values innovation, collaboration, and continuous learning. Clear career progression pathways are available, including potential advancement to roles such as Senior Quality Engineer or Quality Systems Lead, supported by ongoing training and development initiatives. We foster a culture that encourages your growth and recognizes your contributions to our collective 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, color, national origin, gender, sexual orientation, age, disability, or any other protected status. We believe that diverse perspectives and experiences drive innovation and excellence, and we are dedicated to fostering a workplace where everyone can thrive and contribute to our mission of delivering high-quality solutions to our clients.
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