Compliance Specialist Job at Amaris Consulting (Singapore)

Job Description

We are looking for a Quality Compliance Specialist to support quality compliance, inspection readiness, and data integrity activities within a GMP-regulated pharmaceutical manufacturing environment. This role will be responsible for supporting internal audits, regulatory inspections, data integrity programs, and quality systems activities to ensure ongoing compliance with GMP requirements and site quality standards. The successful candidate will work closely with Quality, Manufacturing, Engineering, Validation, and Compliance teams to maintain inspection readiness, manage quality system activities, and promote a strong quality culture across the site. This position requires strong knowledge of GMP manufacturing operations, data integrity principles, and quality compliance processes within pharmaceutical or biologics manufacturing environments.

Job Responsibility

Serve as the Compliance Partner for assigned departments, supporting inspection readiness initiatives and continuous compliance improvement activities
Support regulatory inspections and external audits through logistics coordination, backroom support, documentation management, and stakeholder coordination
Conduct site-wide Data Integrity training programs, including refresher training and new employee onboarding sessions
Review and support Data Integrity documentation, including Audit Trail Reviews, Data Integrity Risk Assessments (DIRA), and related compliance activities
Conduct internal GMP audits and support audit lifecycle activities, including CAPA follow-up, response discussions, and management of open audit actions
Support Quality Risk Management (QRM), Quality Management Review (QMR), Quality Plan, and Regulatory Submission activities through task coordination and follow-up
Review, revise, route, and maintain quality system documentation in accordance with site procedures and GMP requirements
Collaborate with Manufacturing, Engineering, Validation, Quality Assurance, and other cross-functional teams to ensure compliance with quality and regulatory expectations
Support the management and tracking of quality actions, commitments, CAPAs, and compliance-related deliverables to ensure timely completion
Promote quality culture, compliance awareness, and data governance practices across the manufacturing site

Requirements

Bachelor's degree in Life Sciences, Pharmaceutical Sciences, Biotechnology, Engineering, Chemistry, or related disciplines
At least 6 years of Quality Assurance experience within GMP-regulated pharmaceutical, biologics, or API manufacturing environments
Experience in Quality Operations, Quality Compliance, or related GMP quality functions is preferred
Experience supporting internal audits, regulatory inspections, and inspection readiness activities is preferred
Strong knowledge of GMP requirements, Quality Systems, CAPA management, and compliance processes
Good understanding of Data Integrity principles, Data Governance, Audit Trail Review, and Data Integrity Risk Assessment methodologies
Familiarity with manufacturing and laboratory computerized systems such as DeltaV, MES, SAP, LIMS, or related GMP systems is preferred
Understanding of engineering operations, OT/IT systems, and system interfaces within regulated manufacturing environments is advantageous
Strong communication, technical writing, stakeholder management, and training delivery skills
Highly adaptable with the ability to work effectively across multiple functions and manage competing priorities
Team-oriented mindset with a strong commitment to quality, compliance, and continuous improvement

Nice to have

Experience in Quality Operations, Quality Compliance, or related GMP quality functions
Experience supporting internal audits, regulatory inspections, and inspection readiness activities
Familiarity with manufacturing and laboratory computerized systems such as DeltaV, MES, SAP, LIMS, or related GMP systems
Understanding of engineering operations, OT/IT systems, and system interfaces within regulated manufacturing environments

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Compliance Specialist

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