GMP & QMS Quality Assurance Specialist (Singapore)

No deviation Pte Ltd; Singapore; In loco; SGD 70.000 - 110.000; Tempo pieno

Vantaggi offerti da questo lavoro

Generous Leave Policy

Health & Wellness Coverage

Professional Development Opportunities

Inclusive Culture

Career Impact

Descrizione del lavoro

No deviation Pte Ltd in Singapore seeks a Quality Assurance Specialist to establish and continuously improve the Quality Management System for a research laboratory. You will oversee documentation, staff training, risk assessment, supplier oversight, and validation schedules across GLP/GMP and ISO requirements.

You will support the setup of a GMP facility, extending QA practices to cleanroom operations, including management of deviations, CAPA and change control, while coordinating audits and

Competenze

• Postgraduate qualification in Pharmacy, Chemistry or related field.
• At least 4 years in an accredited or GMP-regulated facility with strong GxP knowledge and FDA/HSA GMP requirements.
• Working knowledge of ISO 9001 and ISO 17025.
• Experience managing core QMS processes: document control, deviations, CAPA and change control.
• Hands-on qualification and validation (IQ/OQ/PQ) with strong technical writing for protocols, reports and SOPs.
• Preferred: cleanroom/classified environment, GMP facility experience and familiarity with EU GMP Annex 15, ICH Q7 and data integrity.

Mansioni

• Establish and maintain the laboratory QMS in line with GLP/GMP and FDA/HSA requirements.
• Draft, review and implement QMS documentation including SOPs, work instructions, and lab manuals.
• Train staff on QMS activities and SOP implementation.
• Ensure SOPs are technically valid, approved and followed.
• Manage deviations, CAPA and change control with timely closure.
• Set up and manage the archive and document control system in line with ALCOA+ data integrity.
• Establish and manage a Master Schedule supporting studies in the facility.
• Conduct due diligence on contractors and suppliers; host audits and inspections.
• Perform risk assessments and manage validation schedules and protocols for equipment.

Conoscenze

GxP knowledge

QA documentation

Staff training

Audit readiness

Risk assessment

Validation protocols

CAPA & change control

Documentation control

Formazione

Postgraduate qualification in Pharmacy, Chemistry or related discipline

Strumenti

Computerised system validation (Annex 11 / GAMP 5)

Descrizione del lavoro

No deviation Pte Ltd in Singapore seeks a Quality Assurance Specialist to establish and continuously improve the Quality Management System for a research laboratory. You will oversee documentation, staff training, risk assessment, supplier oversight, and validation schedules across GLP/GMP and ISO requirements.

You will support the setup of a GMP facility, extending QA practices to cleanroom operations, including management of deviations, CAPA and change control, while coordinating audits and