Total 9 quality assurance job vacancies in Singapore

About the Role:

As the Senior Associate of Quality Operations, you will report to the Head of Quality Operations, APAC. Your role focuses on ensuring high-quality standards across our consumer healthcare product portfolio and fostering collaboration to drive a quality-focused mindset throughout the organization.

Key Responsibilities:

1. Product Quality Oversight

• Collaborate with manufacturing and distribution partners to ensure compliance with GMP and applicable standards.
• Manage quality processes, including product release (<3-day timeframe), OOS/NCR/Deviation/CAPA, and stability testing monitoring.
• Oversee change control, customer complaints, and quality investigations, ensuring compliance with regulations and SOPs.
• Support audits and due diligence for new manufacturers and products.

2. Quality Systems and Documentation

• Maintain and enhance the Quality Management System (QMS), including Change Control, CAPA, and Customer Complaints.
• Write, review, and authorize quality documents such as SOPs, work instructions, and investigation reports.
• Monitor performance metrics to ensure ongoing improvement of quality processes.

3. Collaboration and Stakeholder Engagement

• Drive a quality mindset across the organization by collaborating with internal teams and external partners.
• Act as an integral member of the Quality Ops team, supporting continuous improvement initiatives.
• Ensure quality activities align with regulatory requirements and corporate expectations.

Requirements:

To thrive in this role, you will possess:

• A BSc or equivalent in Chemistry, Pharmacy, or related Science/Engineering field.
• At least 5 years of experience in the pharmaceutical/medical device industry, with 3+ years in Quality Assurance.
• Strong knowledge of GMP, GDP, QMS, and quality processes (e.g., CAPA, deviations, change control).
• Experience in supply chain quality or manufacturing quality within a commercial business.
• High tolerance for ambiguity, adaptability to change, and a growth mindset.
• Excellent collaboration skills and the ability to manage multiple tasks in a fast-paced environment.
• Strong customer focus and the ability to work independently while delivering on business needs.

Our client is a global leader in the pharmaceutical industry, dedicated to improving health and well-being through innovative medicines and healthcare solutions.

They seek a Regional QA Specialist to lead regional internal and external audits for their external/contract manufacturers and suppliers, ensuring compliance with regulatory standards and upholding high-quality pharmaceutical, medical devices guidelines and requirements.

Key Points:

• New headcount with growing, reputable pharma MNC
• 5-day work in CDB area with hybrid work arrangements, near MRT
• Overseas travelling opportunities with attractive salary and perks

Responsibilities:

Uphold quality standards and activities of regional external/contract manufacturing organisations, ensure adherence to relevant international regulations, guidelines and industry practises alongside company compliance requirements.

• Perform internal and external audits (supplier or EMO/CMO) audits and assessments to evaluate compliance with quality standards and contractual requirements.
• Monitor EMO/supplier qualification, assessment and performance evaluation processes.
• Develop update and maintain Quality and Technical Agreements with current GxP guidelines.
• Maintain and update internal audit program.
• Plan audit schedules and facilitate process for audit findings to be resolves and all change implementations to be fulfilled with defined targeted datelines in compliance to GMP and company SOPs.
• Proper records and documentation in accordance with regulatory guidelines such as GMP document, site master files, quality manual and agreements.
• Establish and maintain QMS to ensure content compliance to all regulations and company practises, overseeing Validation QA.
• Provide training and guidance to quality staff on quality documentation, including system – Veeva (QMS), compliance training system etc.
• Collaborate with quality team and carry out assigned quality audit activities for continuous improvement throughout the organization.

Requirements:

• Bachelor's degree in a Chemistry, Pharmacy, or a related discipline; preferred Science or Engineering.
• Minimum of 5 years of experience in pharmaceutical or medical device industry, including 3 years in relevant quality compliance and audit roles.
• Experienced in auditing, especially with experience managing overseas EMO/CMO/third party manufacturing experience is highly preferred.
• Strong GMP, Computer system validation, deviation management, CAPA, change control and documentation management in pharmaceutical / medical device MNC environment.
• Demonstrate pro-activeness to drive results even amidst crises and ambiguity, thriving in fast-paced and dynamic environments.
• Successful proven track records of implementing continuous improvement projects with regional teams to enhance overall business operations.
• Possess strong cross-functional collaboration skills and adept stakeholder management capabilities. Skilled in building and maintaining relationships at all levels, both internally and externally.

NOTE: Position title may change based on candidate's experience, qualifications, and company structure at time of offer. This is to ensure alignment with candidate and organizational needs.

The selection process involves careful consideration, and only shortlisted candidates will be contacted. We extend our gratitude to all applicants for their interest and effort in applying.

Principal Consultant: Amber Chen | Registration Number: R22108633 | EA License Number: R1110404

• Regulatory Affairs & Quality Assurance Executive with Medical Device company
• Opportunity to work on local and regional submissions

Partnering with a leading Medical Device player in its field, our client is seeking a Senior / Regulatory Affairs & Quality Assurance Executive.

Reporting to the RA/QA Director, we are looking for someone with good knowledge of regulatory framework.

In this role, you shall assist in the execution of the regulatory strategies in assigned markets throughout the company product life cycle, with a focus on efficient pre-market and post- market regulatory approvals.

You will also support the review and approval of:

• Change control activities
• Product promotional activities
• Product registration
• Product labeling
• Regulatory inspections and audits

You should have at least 2 years’ of regulatory experience in medical devices and a related science degree.

Candidates with more experience will be considered for a 'Senior Executive' role.

For more information, please apply with your updated CV (in Word document).

Ambrose Chan

Registration Number: R1218177
EA License Number: 17C8502

Our client is a global leader in the pharmaceutical industry, dedicated to improving health and well-being through innovative medicines and healthcare solutions.

They seek a Regional Quality Operations Specialist in Singapore to join the Quality Assurance team in ensuring quality compliance with regulatory standards and upholding high-quality pharmaceutical, medical devices guidelines and requirements.

Key Points:

• New headcount with growing, reputable pharma MNC
• 5-day work in CDB area with hybrid work arrangements, near MRT
• Overseas travelling opportunities with attractive salary and perks

Responsibilities:

Uphold quality standards and activities of regional external/contract manufacturing organisations, ensure adherence to relevant international regulations, guidelines and industry practises alongside company compliance requirements.

• Quality oversight of Contract/External Manufacturers (CMO/EMO)/3rd party logistics providers, collaborate with internal teams to review CMO/EMO’s activities and performance such as OOS/NCR/ Deviation and CAPA, Change Control and routine stability testing monitoring, on time and in compliance to GMP and applicable standards
• Quality oversight of our product portfolio; ensuring the necessary quality activities, assessments, and monitoring are being effectively conducted by network of manufacturing and distribution partners
• Ensure complaints are managed and resolved according to compliance requirements of regulations and SOPs within the required timeframes
• Handle product release process from batch receipt, while minimizing recall incidences or critical product quality issues
• Manage change control processes, and action on individual change controls within the defined target dates and in compliance to GMP and iNova SOPs
• Manage individual deviations, NCR & CAPA processes, and action on them in compliance with GMP and organization SOPs, and align timeframes to business needs, to minimise recall incidences or critical product quality issues
• Prepare, review &/or authorise Quality documents and procedures as defined e.g., SOPs, WIs, forms, PQR, Deviation and Quality investigation reports
• Maintain and manage Quality Management System (QMS) e.g., Change Control, Deviations & CAPA, Customer Complaints, including associated Metrics as part of performance monitoring
• Support due diligence checks for new external contract manufacturers, new products; support internal and external audits as required
• Support the maintenance and improvement of the quality system.

Requirements:

• Bachelor's degree in a Chemistry, Pharmacy, or a related discipline; preferred Science or Engineering.
• Minimum of 5 years of experience in pharmaceutical or medical device industry, including 3 years in relevant regional quality assurance roles.
• Experienced in Quality Assurance, especially with experience managing overseas EMO/CMO/third party manufacturing experience is highly preferred.
• Strong GMP, Computer system validation, deviation management, CAPA, change control and documentation management in pharmaceutical / medical device MNC environment.
• Demonstrate pro-activeness to drive results even amidst crises and ambiguity, thriving in fast-paced and dynamic environments.
• Successful proven track records of implementing continuous improvement projects with regional teams to enhance overall business operations.
• Possess strong cross-functional collaboration skills and adept stakeholder management capabilities. Skilled in building and maintaining relationships at all levels, both internally and externally.

NOTE: Position title may change based on candidate's experience, qualifications, and company structure at time of offer. This is to ensure alignment with candidate and organizational needs.

The selection process involves careful consideration, and only shortlisted candidates will be contacted. We extend our gratitude to all applicants for their interest and effort in applying.

Principal Consultant: Amber Chen | Registration Number: R22108633 | EA License Number: R1110404

• Regulatory Affairs & Quality Assurance Executive with global Medical Device MNC
• Opportunity to work on local and regional submissions

Partnering with a global Medical Device MNC with an established branding, our client is seeking a Regulatory Affairs & Quality Assurance Executive (6-Months Contract).

Reporting to the RA/QA Director, we are looking for someone with good knowledge of regulatory framework.

In this role, you shall assist in the execution of the regulatory strategies in assigned markets throughout the company product life cycle, with a focus on efficient pre-market and post- market regulatory approvals.

You will also support the review and approval of:

• Change control activities
• Product promotional activities
• Product registration
• Product labeling
• Regulatory inspections and audits

You should have at least 2 years’ of regulatory experience in medical devices and a related science degree.

For more information, please apply with your updated CV (in Word document).

Ambrose Chan
Registration Number: R1218177
EA License Number: 17C8502

• Regulatory Affairs & Quality Assurance Executive with global Medical Device MNC
• Opportunity to work on local and regional submissions

Partnering with a global Medical Device MNC with an established branding, our client is seeking a Regulatory Affairs & Quality Assurance Executive (6-Months Contract).

Reporting to the RA/QA Director, we are looking for someone with good knowledge of regulatory framework.

In this role, you shall assist in the execution of the regulatory strategies in assigned markets throughout the company product life cycle, with a focus on efficient pre-market and post- market regulatory approvals.

You will also support the review and approval of:

• Change control activities
• Product promotional activities
• Product registration
• Product labeling
• Regulatory inspections and audits

You should have at least 2 years’ of regulatory experience in medical devices and a related science degree.

For more information, please apply with your updated CV (in Word document).

Ambrose Chan
Registration Number: R1218177
EA License Number: 17C8502

Our client is a global leader in the pharmaceutical industry, dedicated to improving health and well-being through innovative medicines and healthcare solutions.

They seek a Regional QA Specialist to lead regional internal and external audits for their external/contract manufacturers and suppliers, ensuring compliance with regulatory standards and upholding high-quality pharmaceutical, medical devices guidelines and requirements.

Key Points:

• New headcount with growing, reputable pharma MNC
• 5-day work in CDB area with hybrid work arrangements, near MRT
• Overseas travelling opportunities with attractive salary and perks

Responsibilities:

Uphold quality standards and activities of regional external/contract manufacturing organisations, ensure adherence to relevant international regulations, guidelines and industry practises alongside company compliance requirements.

• Perform internal and external audits (supplier or EMO/CMO) audits and assessments to evaluate compliance with quality standards and contractual requirements.
• Monitor EMO/supplier qualification, assessment and performance evaluation processes.
• Develop update and maintain Quality and Technical Agreements with current GxP guidelines.
• Maintain and update internal audit program.
• Plan audit schedules and facilitate process for audit findings to be resolves and all change implementations to be fulfilled with defined targeted datelines in compliance to GMP and company SOPs.
• Proper records and documentation in accordance with regulatory guidelines such as GMP document, site master files, quality manual and agreements.
• Establish and maintain QMS to ensure content compliance to all regulations and company practises, overseeing Validation QA.
• Provide training and guidance to quality staff on quality documentation, including system – Veeva (QMS), compliance training system etc.
• Collaborate with quality team and carry out assigned quality audit activities for continuous improvement throughout the organization.

Requirements:

• Bachelor's degree in a Chemistry, Pharmacy, or a related discipline; preferred Science or Engineering.
• Minimum of 5 years of experience in pharmaceutical or medical device industry, including 3 years in relevant quality compliance and audit roles.
• Experienced in auditing, especially with experience managing overseas EMO/CMO/third party manufacturing experience is highly preferred.
• Strong GMP, Computer system validation, deviation management, CAPA, change control and documentation management in pharmaceutical / medical device MNC environment.
• Demonstrate pro-activeness to drive results even amidst crises and ambiguity, thriving in fast-paced and dynamic environments.
• Successful proven track records of implementing continuous improvement projects with regional teams to enhance overall business operations.
• Possess strong cross-functional collaboration skills and adept stakeholder management capabilities. Skilled in building and maintaining relationships at all levels, both internally and externally.

NOTE: Position title may change based on candidate's experience, qualifications, and company structure at time of offer. This is to ensure alignment with candidate and organizational needs.

The selection process involves careful consideration, and only shortlisted candidates will be contacted. We extend our gratitude to all applicants for their interest and effort in applying.

Principal Consultant: Amber Chen | Registration Number: R22108633 | EA License Number: R1110404

• Regulatory Affairs & Quality Assurance Executive with global Medical Device MNC
• Opportunity to work on local and regional submissions

Partnering with a global Medical Device MNC with an established branding, our client is seeking a Regulatory Affairs & Quality Assurance Executive (6-Months Contract).

Reporting to the RA/QA Director, we are looking for someone with good knowledge of regulatory framework.

In this role, you shall assist in the execution of the regulatory strategies in assigned markets throughout the company product life cycle, with a focus on efficient pre-market and post- market regulatory approvals.

You will also support the review and approval of:

• Change control activities
• Product promotional activities
• Product registration
• Product labeling
• Regulatory inspections and audits

You should have at least 2 years’ of regulatory experience in medical devices and a related science degree.

For more information, please apply with your updated CV (in Word document).

Ambrose Chan
Registration Number: R1218177
EA License Number: 17C8502

• Regulatory Affairs & Quality Assurance Executive with global Medical Device MNC
• Opportunity to work on local and regional submissions

Partnering with a global Medical Device MNC with an established branding, our client is seeking a Regulatory Affairs & Quality Assurance Executive (6-Months Contract).

Reporting to the RA/QA Director, we are looking for someone with good knowledge of regulatory framework.

In this role, you shall assist in the execution of the regulatory strategies in assigned markets throughout the company product life cycle, with a focus on efficient pre-market and post- market regulatory approvals.

You will also support the review and approval of:

• Change control activities
• Product promotional activities
• Product registration
• Product labeling
• Regulatory inspections and audits

You should have at least 2 years’ of regulatory experience in medical devices and a related science degree.

For more information, please apply with your updated CV (in Word document).

Ambrose Chan
Registration Number: R1218177
EA License Number: 17C8502