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're looking for a Quality Engineer who combines GMP expertise with a systems mindset supporting daily quality operations, leading investigations, and playing a hands-on role in our eQMS upgrade, maintenance, and administration.
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
- 5+ years in a GMP-regulated environment pharma, personal care, or chemical manufacturing
- 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
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