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About The Company
Hubot | Tri Pac, Inc. CDMO is a leading Contract Development and Manufacturing Organization dedicated to serving the pharmaceutical, personal care, and biotech industries. With a strong commitment to quality, innovation, and customer satisfaction, Hubot operates as a global partner supporting clients across North America and beyond. The company leverages cutting-edge technologies and adheres to stringent regulatory standards to deliver high-quality products and services. Its strategic presence in India through Hubot India Private Limited enables the organization to optimize global operations, foster innovation, and maintain competitive advantages in the rapidly evolving life sciences sector.
About The Role
The Quality Engineer — Quality Systems & eQMS role is a vital position within Hubot’s quality management team, supporting U.S. FDA-regulated operations from India. This remote position offers an exciting opportunity for a seasoned quality professional to drive quality excellence, ensure compliance, and lead critical quality system initiatives. The successful candidate will possess a strong GMP background combined with a systems-oriented mindset, actively supporting daily quality operations, investigations, and continuous improvement efforts. Key responsibilities include managing the eQMS platform, leading root cause investigations, and collaborating with cross-functional teams to uphold regulatory standards and internal quality benchmarks. This role requires a proactive approach, attention to detail, and the ability to operate effectively across different time zones, primarily overlapping with U.S. Eastern Time hours.
Qualifications
The ideal candidate will have over five years of experience working in a GMP-regulated environment within the 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 compliance is essential. Hands-on experience with electronic Quality Management Systems such as Veeva Vault, MasterControl, or TrackWise is required. Strong written and verbal communication skills in English are necessary for effective collaboration across international teams. A bachelor’s degree in Engineering, Quality Assurance, Life Sciences, or a related field is mandatory, with additional certifications or training in quality systems being advantageous.
Responsibilities
- Lead 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 compliance with Good Documentation Practices (GDP) and regulatory standards.
- Evaluate proposed process and design changes, guiding qualification and validation activities to meet change control requirements.
- Monitor and manage procedures related to quarantine, hold, expired, damaged, return goods, and product recalls, ensuring proper documentation and regulatory compliance.
- Conduct routine analysis of key performance indicators (KPIs) and quality metrics, identifying trends and presenting actionable insights to U.S. leadership for strategic decision-making.
- Support the update of risk management files for process changes, implementing process controls, error-proofing measures, and continuous improvement initiatives.
- Collaborate with process owners and cross-functional teams to deliver training, mentorship, and support for QMS requirements and ongoing quality improvements.
- Administer and support eQMS modules including CAPA, document control, deviation management, audit management, and training records, ensuring system integrity and compliance.
- Participate in eQMS upgrades, validation, and maintenance activities, supporting process, equipment, and method validations to ensure 21 CFR Part 11 compliance and audit trail integrity.
- Assist in internal audit programs and prepare for external audits conducted by FDA, ISO, or customers, ensuring readiness and compliance at all times.
Benefits
Joining Hubot offers a dynamic and growth-oriented environment with numerous benefits. Employees can expect a competitive salary package, opportunities for professional development, and a clear career progression pathway toward senior quality roles. The organization fosters a culture of continuous learning, innovation, and collaboration, supported by modern remote working arrangements. Additionally, Hubot provides health and wellness benefits, flexible work hours to accommodate different time zones, and participation in global quality initiatives. Being part of a rapidly growing organization, employees will have the chance to contribute significantly to impactful projects that influence global pharmaceutical manufacturing standards.
Equal Opportunity
Hubot is an equal opportunity employer committed to fostering an inclusive environment for all employees. We celebrate diversity and are dedicated to creating a workplace where everyone feels valued, respected, and empowered. We do not discriminate based on race, gender, age, religion, nationality, disability, or any other protected characteristic. Our hiring process is based solely on merit, qualifications, and the potential to contribute to our organizational goals. We believe that diverse teams drive innovation and excellence, and we are committed to providing equal opportunities for all candidates and employees.
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