Quality Assurance Executive

Humens

Singapore

Presencial

SGD 55 000 - 75 000

Tempo integral

Há 11 dias
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Resumo da oferta

Humens in Singapore seeks a QA professional to ensure GMP compliance and support regulatory standards across the quality management system. You will manage CAPA, deviations, change control, and customer/supplier complaints while reviewing protocols, reports and batch records for timely release.

The role includes conducting audits, supporting qualification/validation activities, monitoring KPIs, and driving continuous improvement within a dynamic quality team.

Qualificações

  • Diploma or Bachelor’s degree in chemistry, pharmacy, or related science.
  • Three years of related experience or more.
  • Must be well organized, detail oriented and able to manage multiple priorities and deadlines.

Responsabilidades

  • Ensure GMP, regulatory requirements, and quality systems compliance.
  • Manage CAPA, deviations, change control, non-conformances and customer/supplier complaints.
  • Support qualification and validation for equipment, processes and systems; review protocols and reports.
  • Conduct internal audits, customer audits and regulatory inspections; ensure timely closure of findings.
  • Review batch records; support batch release and SAP quality transactions.
  • Monitor quality KPIs; perform root cause/risk assessments; support continuous improvement and GMP training.
  • Manage supplier qualification, quality documentation, customer enquiries and regulatory documentation requests.
  • Perform other duties as assigned by the Quality Manager.

Conhecimentos

Well organized
Detail-oriented
Multi-tasking

Formação académica

Diploma or Bachelor’s Degree in Chemistry/Pharmacy or related science

Ferramentas

Microsoft Office

Descrição da oferta de emprego

Job Descriptions:
  • Ensure compliance with GMP, regulatory requirements, company quality systems and applicable international standards.
  • Manage quality system activities including CAPA, deviations, change control, non-conformances and customer/supplier complaints.
  • Support qualification and validation activities for equipment, processes and systems, including review of protocols and reports.
  • Conduct and support internal audits, customer audits and regulatory inspections and ensure timely closure of audit findings.
  • Review manufacturing and packaging batch records and support batch release activities, including SAP quality transaction.
  • Monitor quality KPIs, perform root cause/risk assessments, support continuos improvement initiatives and conduct quality/GMP training.
  • Manage supplier qualification, quality documentation, customer quality enquiries and regulatory documentation requests.
  • Perform any other duties and responsibilities as assigned by the Quality Mnager whenever necessary.
Job Requirements:
  • Minimum Diploma or Bachelor's Degree with background in Chemistry, Pharmacy and or any science related courses.
  • At least 3 years'related experience
  • Well organized, detail-oriented and able to manage multiple priorities and deadlines.
  • Proficient in Microsoft Office application
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