374 Quality Assessor jobs in Malaysia
Quality and Compliance Assessor
Posted 6 days ago
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Overview
Quality and Compliance Assessor – Syneos Health, Kuala Lumpur, Malaysia.
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Why Syneos Health: we are committed to developing our people, with career development and progression, supportive line management, training, peer recognition and a total rewards program; we embrace a Total Self culture; and we believe diversity of thoughts and backgrounds strengthens our teams. We operate globally with a culture of belonging.
Responsibilities- Performs Routine and Non-Routine Monitoring Evaluation Visits (MEVs) and/or Sign Off Visits (SOVs) as assigned.
- Assists in the analysis of qualitative oversight data to identify quality improvement signals.
- Conducts root cause analysis of quality signals and develops a plan and/or recommended actions, including supporting implementation of process and efficiency improvements.
- Identifies training needs for CRAs through analysis of aggregated oversight data to meet standards in quality and efficiency across Global Clinical Operation (GCO).
- May conduct trainings on areas of improvement identified through quality oversight data analysis and/or audit findings in collaboration with Learning Center of Excellence, Corporate Quality and Clinical Operations Management.
- Supports Clinical Operations in addressing ad hoc or escalated quality concerns within the region.
- Acts as consultant to local/regional operations related to quality oversight best practices and tools.
- May assist in the review of Clinical Monitoring SOPs, tools or templates related to monitoring oversight.
- Performs other work-related duties as assigned.
- Bachelor's degree in biological science or healthcare-related field required.
- Minimum of 5 years of experience in monitoring or auditing clinical research programs at a CRO, biotech or large pharmaceutical company.
- Additional industry experience as a CRA Line Manager, Project Manager, Clinical Team Manager or Quality Control role preferred.
- In-depth knowledge of ICH/GCP, local regulations, drug development process and clinical operations required.
- Knowledge of multiple therapeutic areas.
- Ability to work independently within a matrixed environment across multiple projects, geographical locations and organizational levels.
- Strong attention to detail, organizational, documentation and presentation skills.
- Strong interpersonal and communication skills with the ability to identify and solve problems and communicate issues tactfully.
- Ability to perform root cause analysis.
- Ability to travel up to 75% regularly, including internationally.
- Proficiency in written and spoken English; additional languages may be preferred in regional locations.
- Role supports multiple countries.
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 studies across 73,000 sites and 675,000+ trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health at .
#J-18808-LjbffrQuality and Compliance Assessor
Posted 6 days ago
Job Viewed
Job Description
Quality and Compliance Assessor – Syneos Health, Kuala Lumpur, Malaysia. Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Why Syneos Health: we are committed to developing our people, with career development and progression, supportive line management, training, peer recognition and a total rewards program; we embrace a Total Self culture; and we believe diversity of thoughts and backgrounds strengthens our teams. We operate globally with a culture of belonging. Responsibilities
Performs Routine and Non-Routine Monitoring Evaluation Visits (MEVs) and/or Sign Off Visits (SOVs) as assigned. Assists in the analysis of qualitative oversight data to identify quality improvement signals. Conducts root cause analysis of quality signals and develops a plan and/or recommended actions, including supporting implementation of process and efficiency improvements. Identifies training needs for CRAs through analysis of aggregated oversight data to meet standards in quality and efficiency across Global Clinical Operation (GCO). May conduct trainings on areas of improvement identified through quality oversight data analysis and/or audit findings in collaboration with Learning Center of Excellence, Corporate Quality and Clinical Operations Management. Supports Clinical Operations in addressing ad hoc or escalated quality concerns within the region. Acts as consultant to local/regional operations related to quality oversight best practices and tools. May assist in the review of Clinical Monitoring SOPs, tools or templates related to monitoring oversight. Performs other work-related duties as assigned. Qualifications
Bachelor's degree in biological science or healthcare-related field required. Minimum of 5 years of experience in monitoring or auditing clinical research programs at a CRO, biotech or large pharmaceutical company. Additional industry experience as a CRA Line Manager, Project Manager, Clinical Team Manager or Quality Control role preferred. In-depth knowledge of ICH/GCP, local regulations, drug development process and clinical operations required. Knowledge of multiple therapeutic areas. Ability to work independently within a matrixed environment across multiple projects, geographical locations and organizational levels. Strong attention to detail, organizational, documentation and presentation skills. Strong interpersonal and communication skills with the ability to identify and solve problems and communicate issues tactfully. Ability to perform root cause analysis. Ability to travel up to 75% regularly, including internationally. Proficiency in written and spoken English; additional languages may be preferred in regional locations. Role supports multiple countries. Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 studies across 73,000 sites and 675,000+ trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health at
.
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Executive, Quality Assurance & Control
Posted 1 day ago
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Manage all quality & safety activities and inspectors within an assigned area. Responsible for preparation and effective implementation of documented quality and safety systems, procedures, and instructions. Monitor and verify incoming raw materials, production processes, and products using statistical techniques. Full commitment is expected to ensure total quality and safety management is achieved.
JOB DESCRIPTIONS- Ensure staff perform routines in accordance with job specifications.
- Initiate actions to prevent product nonconformity and apply modern quality techniques to improve product quality.
- Verify the implementation of solutions, identify, and record any product quality issues.
- Control further processing, delivery, or installation of non-conforming products until deficiencies are corrected.
- Prepare documented quality system procedures and instructions in accordance with requirements, ensuring traceability in case of non-compliance.
- Establish and maintain a documented quality system to ensure product conformance to specified requirements.
- Conduct quality audits and check manufacturing process conformance to documented specifications.
- Evaluate and analyze defects using statistical and graphical techniques for better visualization and trend tracking.
- Serve customers with quality information, handle customer returns and complaints.
- Update and implement applicable changes to improve overall quality and yield.
- Train, brainstorm, and upgrade staff regarding quality and safety issues.
- Minimize variability and reduce wastage/cost by providing early warnings and fostering collaboration across departments towards high quality and safety at low production costs.
- Manage the QC laboratory.
- Support quality management in the SAP system.
- Bachelor’s degree or professional degree in Food Science or equivalent from a recognized institution.
Quality Assurance & Control Analyst
Posted 2 days ago
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Job Description
Job Summary
Liaises with business stakeholders, end users, business analysts, project managers, and development teams to identify and document the required tests and test scenarios, ensuring that these cover all the business requirements. They perform, monitor, and report the test execution progress and the overall quality experience of the target test system.
Job Accountabilities - Key Accountabilities
- Develop test cases and test scenarios based on the business requirements and conduct peer reviews on test coverage and test cases produced by the test team. They participate in walk throughs with respective business stakeholders as appropriate.
- Contribute to the testing plan including the agreed code drop schedule, execute test cases as per the agreed plan, and log and retest defects as necessary using the appropriate test tools.
- Conduct root cause analysis and troubleshooting of defects, and track, control and resolve testing issues and queries.
- Highlight any risks or slippages to the test lead or manager and participate in defect triage meetings providing defect updates.
Job Qualifications - Bachelor’s degree in Quality Assurance, Computer Science, Engineering, Information Technology, or a related field.
Preferred:
• 3-5 years of experience in Quality Assurance, Quality Control, or Software Testing.
• Hands-on experience in manual and automated testing methodologies.
At Zurich we are proud of our culture. We are passionate about Diversity and Inclusion. We want you to bring your whole self to work we have a diverse mix of customers, and we want our employee base to reflect that.
Our diversity and inclusion initiatives are creating an environment where everyone feels welcome regardless of protected characteristics.
With the above in mind, we accept applications from everyone regardless of your background, beliefs, or culture.
We are committed to continuous improvement, and we offer access to a comprehensive range of training and development opportunities. Zurich is passionate about supporting employees to help others by getting involved in volunteering, charitable and community activity.
So, make a difference. Be challenged. Be inspired. Be supported, Love what you do. Work for us.
• Location(s): MY - Kuala Lumpur
• Schedule: Fulltime
• Recruiter name: Caroline Louis
Quality Assurance & Control Analyst
Posted 6 days ago
Job Viewed
Job Description
Job ID:
Job Summary:
The QA & Control Analyst liaises with business stakeholders, end users, business analysts, project managers, and development teams to identify and document required tests and test scenarios, ensuring coverage of all business requirements. They perform, monitor, and report on test execution progress and the overall quality of the target test system.
Key Responsibilities:
- Develop test cases and scenarios based on business requirements, conduct peer reviews, and participate in walkthroughs with stakeholders.
- Contribute to the testing plan, execute test cases, log and retest defects using appropriate tools.
- Conduct root cause analysis, troubleshoot defects, and track testing issues.
- Highlight risks or slippages to the test lead or manager and participate in defect triage meetings.
Qualifications:
- Bachelor’s degree in Quality Assurance, Computer Science, Engineering, Information Technology, or related field.
- Preferred: 3-5 years experience in QA, QC, or Software Testing.
- Hands-on experience with manual and automated testing methodologies.
Additional Information:
At Zurich, we value diversity and inclusion, creating an environment where everyone feels welcome. We offer training and development opportunities and support community involvement. Join us to make a difference, be challenged, and enjoy your work.
#J-18808-LjbffrExecutive, Quality Assurance & Control
Posted 1 day ago
Job Viewed
Job Description
Ensure staff perform routines in accordance with job specifications. Initiate actions to prevent product nonconformity and apply modern quality techniques to improve product quality. Verify the implementation of solutions, identify, and record any product quality issues. Control further processing, delivery, or installation of non-conforming products until deficiencies are corrected. Prepare documented quality system procedures and instructions in accordance with requirements, ensuring traceability in case of non-compliance. Establish and maintain a documented quality system to ensure product conformance to specified requirements. Conduct quality audits and check manufacturing process conformance to documented specifications. Evaluate and analyze defects using statistical and graphical techniques for better visualization and trend tracking. Serve customers with quality information, handle customer returns and complaints. Update and implement applicable changes to improve overall quality and yield. Train, brainstorm, and upgrade staff regarding quality and safety issues. Minimize variability and reduce wastage/cost by providing early warnings and fostering collaboration across departments towards high quality and safety at low production costs. Manage the QC laboratory. Support quality management in the SAP system. JOB REQUIREMENTS
Bachelor’s degree or professional degree in Food Science or equivalent from a recognized institution.
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Quality Assurance & Control Analyst
Posted 3 days ago
Job Viewed
Job Description
Liaises with business stakeholders, end users, business analysts, project managers, and development teams to identify and document the required tests and test scenarios, ensuring that these cover all the business requirements. They perform, monitor, and report the test execution progress and the overall quality experience of the target test system. Job Accountabilities - Key Accountabilities Develop test cases and test scenarios based on the business requirements and conduct peer reviews on test coverage and test cases produced by the test team. They participate in walk throughs with respective business stakeholders as appropriate. Contribute to the testing plan including the agreed code drop schedule, execute test cases as per the agreed plan, and log and retest defects as necessary using the appropriate test tools. Conduct root cause analysis and troubleshooting of defects, and track, control and resolve testing issues and queries. Highlight any risks or slippages to the test lead or manager and participate in defect triage meetings providing defect updates.
Job Qualifications Bachelor’s degree in Quality Assurance, Computer Science, Engineering, Information Technology, or a related field.
Preferred: •
3-5 years of experience in Quality Assurance, Quality Control, or Software Testing. •
Hands-on experience in manual and automated testing methodologies.
At Zurich we are proud of our culture. We are passionate about Diversity and Inclusion. We want you to bring your whole self to work we have a diverse mix of customers, and we want our employee base to reflect that. Our diversity and inclusion initiatives are creating an environment where everyone feels welcome regardless of protected characteristics. With the above in mind, we accept applications from everyone regardless of your background, beliefs, or culture. We are committed to continuous improvement, and we offer access to a comprehensive range of training and development opportunities. Zurich is passionate about supporting employees to help others by getting involved in volunteering, charitable and community activity. So, make a difference. Be challenged. Be inspired. Be supported, Love what you do. Work for us. •
Location(s): MY - Kuala Lumpur •
Schedule: Fulltime •
Recruiter name: Caroline Louis
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Quality Assurance & Control Analyst
Posted 6 days ago
Job Viewed
Job Description
Job Summary:
The QA & Control Analyst liaises with business stakeholders, end users, business analysts, project managers, and development teams to identify and document required tests and test scenarios, ensuring coverage of all business requirements. They perform, monitor, and report on test execution progress and the overall quality of the target test system.
Key Responsibilities:
Develop test cases and scenarios based on business requirements, conduct peer reviews, and participate in walkthroughs with stakeholders.
Contribute to the testing plan, execute test cases, log and retest defects using appropriate tools.
Conduct root cause analysis, troubleshoot defects, and track testing issues.
Highlight risks or slippages to the test lead or manager and participate in defect triage meetings.
Qualifications:
Bachelor’s degree in Quality Assurance, Computer Science, Engineering, Information Technology, or related field.
Preferred: 3-5 years experience in QA, QC, or Software Testing.
Hands-on experience with manual and automated testing methodologies.
Additional Information:
At Zurich, we value diversity and inclusion, creating an environment where everyone feels welcome. We offer training and development opportunities and support community involvement. Join us to make a difference, be challenged, and enjoy your work.
#J-18808-Ljbffr
Senior Engineer - Quality Assurance/Quality Control 1
Posted 3 days ago
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Job Description
Senior Engineer - Quality Assurance/Quality Control 1 By continuing to use and navigate this website, you are agreeing to the use of cookies.
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The Quality and Assurance Engineer provides quality & completions assurance support to Australian projects within ACC from the Kuala Lumpur Gamuda Hub.
Key Responsibilities1) DTI Values
-Work in accordance with DTI’s values and demonstrate commitment, active involvement and leadership regarding zero harm, client, people, and financial accountabilities.
2)Project Systems Support
-Assist the Project Quality & Completions Manager/s to:
-Develop the register of Project contract completions & handover requirements and track progress against deliverable development.
-Assist project set-up in ACC and Gdos, including uploading the Work Breakdown Structure into -ACC/Gdos and developing the project folder structure as required.
3)Project Quality Assurance
-Conduct daily audits within ACC to ensure folders contain the required list of deliverables by the due dates.
-Provide feedback and advice to the Project quality Team about the completeness of records within the ACC and DGos system.
-Assist with the upload of records to the Gdos and ACC system.
4)Coaching and Training
-Assist project team members to understand the functionality of ACC and Gdos.
-Remain abreast of new features within ACC and Gdos and provide coaching to team members to ensure all are across relevant updates.
-Provide coaching engineering teams to interpret reports to set quality and completions activity priorities on a weekly basis.
5)Reporting
-Reporting and Communication:
-Provide project reporting to assist the team to have visibility of the status of quality and completions records.
-Provide input to project monthly reporting as required.
Qualifications- Minimum: 5 years’ experience working as a professional engineer within the construction industry (preferably civil or structures).
- Minimum: Experience in using digital systems for the capture of construction quality documentation (as required by the ITP) in support of completions and handover.
- Minimum: Experience in the use of Power BI (or similar tool) to report against construction quality progress.
Preferred / Optional: Experience in checking the completeness of digital quality records in preparation for handover.
Skills & AbilitiesExperience:
- Ability to speak, write and understand the English language in relation to construction terminology.
- Ability to work independently and collaboratively in a dynamic environment.
- Ability to review and recommend opportunities for improvement, including gaps or new processes or to streamline transactional activities.
Ability to administer multiple and competing tasks concurrently.
Skills & Knowledge:
- Professional presentation and conduct.
- Ability to prepare reports and communicate required actions to team members.
- Proficient in using Power BI to report against required outcomes.
- To have high levels of self-discipline, self-motivation, and energy.
- Intermediate to advanced knowledge of MS Office applications including Excel, PowerPoint, Outlook, and Word.
Ability to embrace DTI’s values.
Expected Minimum Years of ExperienceMinimum 5 years experience
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#J-18808-LjbffrSenior Engineer - Quality Assurance/Quality Control 1
Posted 3 days ago
Job Viewed
Job Description
Regular/Temporary: Permanent
Location: Petaling Jaya, 10, MY, 47820
Job SummaryThe Quality and Assurance Engineer provides quality & completions assurance support to Australian projects within ACC from the Kuala Lumpur Gamuda Hub.
Key Responsibilities- DTI Values
- Work in accordance with DTI’s values and demonstrate commitment, active involvement and leadership regarding zero harm, client, people, and financial accountabilities. - Project Systems Support
- Assist the Project Quality & Completions Manager/s to:
- Develop the register of Project contract completions & handover requirements and track progress against deliverable development.
- Assist project set-up in ACC and Gdos, including uploading the Work Breakdown Structure into ACC/Gdos and developing the project folder structure as required. - Project Quality Assurance
- Conduct daily audits within ACC to ensure folders contain the required list of deliverables by the due dates.
- Provide feedback and advice to the Project quality Team about the completeness of records within the ACC and DGos system.
- Assist with the upload of records to the Gdos and ACC system. - Coaching and Training
- Assist project team members to understand the functionality of ACC and Gdos.
- Remain abreast of new features within ACC and Gdos and provide coaching to team members to ensure all are across relevant updates.
- Provide coaching engineering teams to interpret reports to set quality and completions activity priorities on a weekly basis. - Reporting
- Provide project reporting to assist the team to have visibility of the status of quality and completions records.
- Provide input to project monthly reporting as required.
- Minimum: 5 years’ experience working as a professional engineer within the construction industry (preferably civil or structures).
- Minimum: Experience in using digital systems for the capture of construction quality documentation (as required by the ITP) in support of completions and handover.
- Minimum: Experience in the use of Power BI (or similar tool) to report against construction quality progress.
Preferred / Optional: Experience in checking the completeness of digital quality records in preparation for handover.
Skills & AbilitiesExperience:
- Ability to speak, write and understand the English language in relation to construction terminology.
- Ability to work independently and collaboratively in a dynamic environment.
- Ability to review and recommend opportunities for improvement, including gaps or new processes or to streamline transactional activities.
Ability to administer multiple and competing tasks concurrently.
Skills & Knowledge:
- Professional presentation and conduct.
- Ability to prepare reports and communicate required actions to team members.
- Proficient in using Power BI to report against required outcomes.
- To have high levels of self-discipline, self-motivation, and energy.
- Intermediate to advanced knowledge of MS Office applications including Excel, PowerPoint, Outlook, and Word.