QA & QC Assistant - GMP, QMS & Audits

Recruit Express Pte Ltd; Singapore; Vor Ort; SGD 28.000 - 33.000; Vollzeit

Zusammenfassung

Recruit Express Pte Ltd is seeking a Quality Assurance/QA role based in Singapore to implement SOPs and QMS documentation in line with GMP. The role covers QC testing, batch release support, CAPA investigations, regulatory submissions, audits and ongoing quality system improvements.

You will coordinate calibrations, validations, and R&D support from a quality/regulatory perspective, ensuring traceability of retention samples and regression of quality issues across production areas.

Qualifikationen

• Prepare, review, revise and implement SOPs and QMS documents per GMP.
• Ensure GMP compliance and follow company procedures.
• Perform QC activities including sampling and testing per specs.
• Support batch release per specifications and procedures.
• Investigate OOS, deviations, non-conformances and CAPA.
• Coordinate calibration and validation activities and review reports.
• Maintain retention samples, document control and PQRs.
• Liaise with regulators and internal/external stakeholders.

Aufgaben

• Prepare, review, revise and implement SOPs and QMS documents in accordance with GMP.
• Ensure compliance with GMP requirements and established company procedures.
• Perform QC activities, including sampling, lab testing per approved specs, and review of test reports for disposition.
• Support and/or perform batch/product release activities per approved specs.
• Investigate OOS, deviations, non-conformances and CAPA implementation.
• Coordinate external lab testing where applicable and review COAs.
• Plan calibration, validation protocols and reports, and manage related docs.
• Handle product quality reviews and quality risk assessments.

Kenntnisse

GMP compliance

Quality Control

CAPA investigations

Regulatory submissions

Audit participation

SOPs documentation

QA/QMS processes

Documentation management

Team coordination

Ausbildung

Min Nitec/Diploma in Science

Jobbeschreibung

Recruit Express Pte Ltd is seeking a Quality Assurance/QA role based in Singapore to implement SOPs and QMS documentation in line with GMP. The role covers QC testing, batch release support, CAPA investigations, regulatory submissions, audits and ongoing quality system improvements.

You will coordinate calibrations, validations, and R&D support from a quality/regulatory perspective, ensuring traceability of retention samples and regression of quality issues across production areas.