Equipment Qualification Engineer (QC Analytical)

ALWAYSHIRED PTE. LTD.; Singapore; On-site; SGD 50,000 - 80,000; Full time

Job summary

A leading pharmaceutical company in Singapore is seeking a qualified candidate for a role focused on the qualification and maintenance of analytical instruments. The successful applicant will be responsible for executing IQ/OQ/PQ, maintaining validation documentation, and ensuring compliance with regulatory standards in a QC laboratory setting. A bachelor's degree and 2-5 years of experience in a pharmaceutical QC lab are required, along with strong knowledge of various analytical instruments and regulatory principles. This position offers a chance to contribute to critical quality processes in a dynamic environment.

Qualifications

• 2–5 years’ experience in a pharmaceutical QC lab with hands-on equipment qualification.
• Strong knowledge of analytical instruments such as HPLC, GC, ICP, UV, KF, TOC.
• Familiarity with GMP, GxP, and data integrity principles.

Responsibilities

• Perform IQ/OQ/PQ for analytical instruments per GMP and internal procedures.
• Lead equipment commissioning, installation, and troubleshooting activities.
• Maintain validation documentation and equipment logbooks.

Skills

Analytical instruments knowledge

Equipment qualification (IQ/OQ/PQ)

GMP and GxP familiarity

Calibration management

Education

Bachelor in Chemistry, Pharmaceutical Science, Life Sciences, Engineering

Tools

HPLC

GC

ICP

UV

KF

TOC

Job description

Responsibilities

• Perform and execute IQ/OQ/PQ for analytical instruments in accordance with GMP, GAMP 5, and internal procedures.
• Prepare and review qualification protocols, reports, URS, DQ, and validation documentation.
• Maintain and update the Equipment Qualification Master List and ensure timely requalification.
• Lead and support equipment commissioning, installation, and troubleshooting activities.
• Oversee the qualification and lifecycle of QC laboratory instruments including:
  HPLC/UPLC, GC, UV-Vis, FTIR, KF, TOC, AAS/ICP, balances, pH meters, stability chambers and other analytical equipment
• Coordinate and review vendor calibration and preventive maintenance activities.
• Ensure all instruments meet regulatory, data integrity, and operational requirements.
• Support change controls, deviations, CAPA, and risk assessments related to QC equipment.
• Maintain equipment logbooks, documentation, and validation files in compliance with ALCOA+ and GMP.
• Act as SME during internal/external audits (HSA, FDA, EMA) for equipment qualification.

Requirements

• Bachelor in Chemistry, Pharmaceutical Science, Life Sciences, Engineering or related disciplines.
• 2–5 years’ experience in a pharmaceutical QC lab with hands‑on equipment qualification (IQ/OQ/PQ).
• Strong knowledge of analytical instruments such as HPLC, GC, ICP, UV, KF, TOC, etc.
• Familiarity with GMP, GxP, Annex 11, 21 CFR Part 11, ALCOA+, and data integrity principles.
• Experience with validation documentation, equipment lifecycle, calibration, or vendor management is preferred.

Interested candidates please apply online or send your latest CV to [e-mail]

AlwaysHired Pte Ltd

Reg No: R1549345

EA: 24C2293

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