Quality Engineer — Quality Systems & eQMS

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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