Website:
hubot.us
Job details:
Quality Engineer — Quality Systems & eQMS (Remote · India) 📍 India (Remote) | Full-Time | Supporting U.S. Operations | IST–EST Overlap Required
Drive quality excellence for a U.S. FDA-regulated CDMO from India.
Hubot, Inc. is a U.S.-based CDMO serving Fortune 500 pharmaceutical and personal care brands across North America and globally. Through Hubot India Private Limited, we're building a high-caliber Quality function that operates in direct partnership with our U.S. team.
We are looking for an experienced Senior Quality Engineer to join our team in India, someone who thinks beyond checklists and brings a true systems mindset to Quality. In this role, you will be the backbone of our Quality Management System (QMS), driving robust investigation practices, strengthening compliance, and building a culture of sustained quality excellence across the organization.
This is a role for a seasoned quality professional who has spent 10+ years working hands-on with OOS (Out of Specification) investigations, CAPA (Corrective and Preventive Action), deviation management, root cause investigations, Annual Product Reviews (APR), and audits — and who is now ready to bring that depth of experience into a role focused on strengthening systems, processes, and compliance frameworks rather than validation activities.
Note: This role is focused on Quality Systems and Compliance — candidates with a primarily validation-focused background are not what we're looking for here.
What You'll Do
- Lead failure investigations using root cause analysis tools (5-Why, Fishbone, FMEA) and drive CAPA implementation
- Review Batch Records, SOPs, and change controls for GDP compliance and regulatory alignment
- Evaluate proposed process and design changes for change control requirements, guide qualification and validation criteria
- Monitor and implement procedures related to Quarantine, Hold, Expired, Damaged, Return Goods, and Recalled product
- Provide routine analysis of KPIs and quality performance indicators; identify trends and present findings to U.S. leadership
- Support risk management file updates for process changes; implement process controls and error-proofing measures
- Collaborate with functional process owners to train, mentor, and facilitate QMS requirements and continuous improvement
- Support and administer eQMS modules CAPA, document control, deviation management, audit management, and training records
- Contribute to eQMS upgrade, validation, and ongoing maintenance; support process, equipment, and method validation activities as required; ensure 21 CFR Part 11 compliance and audit trail integrity
- Support internal audit programs and assist in preparation for FDA, ISO, and customer audits
What You Bring
- 10+ years in a GMP-regulated environment pharma, personal care, or chemical manufacturing
- Strong, demonstrated expertise in QMS, OOS, CAPA, Deviation Management, Investigations, APR, and Audits
- Working knowledge of FDA 21 CFR 210/211, ISO 9001, ISO 22716, and 21 CFR Part 11
- Hands-on experience with eQMS platforms (Veeva Vault, MasterControl, TrackWise, or similar)
- Strong written English and ability to collaborate effectively across time zones
- BA/BS in Engineering, Quality, Life Sciences, or related field
How We Measure Success
- ✅ CAPA closure rate on time ≥ 95%
- ✅ GDP adherence on batch record and SOP reviews ≥ 98%
- ✅ eQMS module uptime and audit trail integrity 100%
- ✅ Internal audit findings closed within defined timelines ≥ 90%
- ✅ At least one eQMS process improvement or automation implemented By Month 9
Why Hubot India
- 🚀 25–30% YoY growth forecast through 2030
- 🌐 Direct visibility to U.S. Quality, Production, and Regulatory leadership
- 💻 Meaningful eQMS ownership not just support
- 📈 Clear path to Senior Quality Engineer or Quality Systems Lead
This role requires 4–5 hours of daily overlap with U.S. Eastern Time (~ 5–10 PM IST).
📩 Apply via LinkedIn or message for a confidential conversation 🌐 www.hubot.us
#QualityEngineer #eQMS #GMP #FDACompliance #CDMO #RemoteJobsIndia #QualityAssurance #HubotIndia #LifeSciences
Click on Apply to know more.