GMP QA & QMS Specialist — Lab Compliance Leader

No deviation Pte Ltd.; Singapore; Presencial; SGD 90 000 - 130 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Generous leave policy

Health & wellness coverage

Professional development opportunities

Inclusive culture

Shape the future in pharma

Resumo da oferta

No deviation Pte Ltd. is seeking a Quality Assurance Specialist in Singapore to establish and maintain the Quality Management System across R&D and GMP facilities.

You will manage QMS documentation, staff training, supplier oversight, risk assessment, and validation activities to support a growing laboratory and cleanroom operations. The role requires hands-on experience with deviations, CAPA, change control, and experience preparing for regulatory inspections.

Qualificações

• Postgraduate qualification in Pharmacy or related discipline.
• Experience in GMP/GLP facilities with strong GxP knowledge.
• Demonstrated experience with documentation and SOPs.

Responsabilidades

• Establish and maintain QMS per GLP/GMP and FDA/HSA requirements.
• Draft, review and implement QMS documentation and SOPs.
• Train staff on QMS activities and SOP implementation.
• Lead deviations, CAPA and change control processes to ensure timely closure.
• Host audits and inspections, acting as primary contact for auditors.

Conhecimentos

QMS management

GxP compliance

Documentation

Audit readiness

Technical writing

Formação académica

Postgraduate qualification in Pharmacy

Descrição da oferta de emprego

No deviation Pte Ltd. is seeking a Quality Assurance Specialist in Singapore to establish and maintain the Quality Management System across R&D and GMP facilities.

You will manage QMS documentation, staff training, supplier oversight, risk assessment, and validation activities to support a growing laboratory and cleanroom operations. The role requires hands-on experience with deviations, CAPA, change control, and experience preparing for regulatory inspections.