- Singapore
Amaris Consulting Hiring! Full Time Compliance Specialist in - Ricebowl
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JOB SUMMARY
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.
ABOUT THE JOB
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
ABOUT YOU
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
Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.
At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!
JOB SUMMARY
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.
ABOUT THE JOB
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
ABOUT YOU
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
Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.
At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!
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