Quality Engineer — Quality Systems Patna
Quality Engineer — Quality Systems Patna
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Patna, India -
Posted: less than a week ago
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Description
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-regula Apply on Kit Job: kitjob.in/job/4mhlng
· 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-regula Apply on Kit Job: kitjob.in/job/4mhlng
Highlights
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Company nameHubot | Tri Pac, Inc. CDMO -
Job positionQuality Engineer — Quality Systems Patna
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