GMP QA Specialist – QMS & Compliance Leader

NO DEVIATION PTE. LTD.

Singapore

On-site

SGD 90,000 - 120,000

Full time

4 days ago
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Job summary

No Deviation Pte. Ltd. in Singapore seeks a Quality Assurance Specialist to establish and maintain the QA Management System for a research laboratory.

You will support day‑to‑day QA tasks, training, document control and supplier oversight while extending QA to a new GMP facility with cleanroom operations. The role requires 4+ years in GMP‑regulated settings, strong GxP knowledge, and hands‑on qualification/validation experience.

Qualifications

  • Postgraduate qualification in Pharmacy or related discipline is required.
  • 4+ years in an accredited or GMP-regulated facility with GxP knowledge.
  • Experience with ISO 9001 and ISO 17025 is preferred.
  • Strong technical writing skills for protocols, reports and SOPs.
  • Familiarity with EU GMP Annex 15, ICH Q7 and data integrity is a plus.

Responsibilities

  • Establish, maintain and improve the QMS for the R&D and GMP facilities.
  • Draft and implement SOPs, work instructions and lab manuals.
  • Train staff on QMS activities and SOPs.
  • Manage deviations, CAPA and change control with timely closure.
  • Lead audits and host third‑party inspections; act as main contact.
  • Maintain archive, document control and ALCOA+ data integrity principles.

Skills

QMS management
Staff training
Risk assessment
Audits

Education

Postgraduate qualification in Pharmacy

Tools

IQ/OQ/PQ protocols
Document control system

Job description

No Deviation Pte. Ltd. in Singapore seeks a Quality Assurance Specialist to establish and maintain the QA Management System for a research laboratory.

You will support day‑to‑day QA tasks, training, document control and supplier oversight while extending QA to a new GMP facility with cleanroom operations. The role requires 4+ years in GMP‑regulated settings, strong GxP knowledge, and hands‑on qualification/validation experience.

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