Position Overview

We are seeking a dedicated and detail-oriented Quality Assurance Specialist to assist our Quality Assurance Manager. The successful candidate will be responsible for performing a full spectrum of quality-related activities and developing/reviewing quality and inspection plans

Education / Certificates

Degree in Engineering, Science, or a related field.

Job Responsibilities

• Conduct First Article Inspection (FAI), Dedicated Product Release Verification, and material review.
• Develop and review quality and inspection plans.
• Manage quality-related activities with customers and internal staff, including handling customer rejects, product defects, and non-conforming materials.
• Perform product and system audits for both in-house and vendor operations.
• Participate in continual improvement initiatives.
• Perform other duties and responsibilities as assigned

Requirements

• Minimum of 2 years of experience in Quality Management.
• Knowledge of AS 9100 / ISO 9001 Quality Management System requirements.
• Proficiency in Geometric Dimensioning & Tolerancing.
• Experience with product inspection methods.
• Knowledge of Coordinate Measuring Machine (CMM) applications is an advantage.
• Strong understanding of Quality Statistical Tools and Methodologies such as Cpk, SPC, GR&R, and Six Sigma tools.
• Proficient in writing quality manuals and procedures.
• Ability to lead and/or perform Internal Audits.

Job Summary

Responsible for management of Asia Quality System, Policies, Programs and Initiatives. Part of the Global Quality Team to maintain global quality system and drive global initiative.

Role and Responsibilities

Quality Systems

1. Supports overall maintenance of quality systems

2. Monitor and reports on the quality performance for Asia Operations such as product quality performance, supplier performance and gaps for continuous improvement to the management team

3. Maintains the Master control and ISO document control system

4. Maintains customer related documents such as Quality Agreement, PPAP

5. Part of the Global Quality Team, to design and implementation of global policies and systems

Quality Policies

6. Ensures effective implementation of all company quality policies

7. Implements ISO and other recognized standards

8. Implements and monitors statistical techniques such as R&R’s to identify opportunities for improvement.

9. Sets, communicates, and implements quality objectives in line with business goals

10. Manage supplier and customer programs (CCAR, ICAR and SCARs) to ensure that complaints are handled effectively and timely.

11. Support and work with different stakeholders on reporting, monitoring and resolution on customer complaints.

12. Support and work with Supply Chain and Operation on supplier quality issues.

Auditing

13. Leads ISO quality standards implementation as Management Representative.

14. Conducts and leads quality audits to specific quality standards.

15. Leads customer related audits

16. Conducts supplier audits

17. Conducts internal audit investigations for product quality and process issues

18. Responsible for ensuring timely resolution to audit findings

Training

19. Provides training for all employees on basic quality and statistical concepts

20. Provides training to appropriate personnel for updates and changes to quality policy

21. Attends relevant external training sessions/courses and shares learning internally

Job Requirements:

• Degree or equivalent experience in a field of study such as chemistry, business, accounting, engineering, etc.

• Certificate in Quality Engineering is preferred.

• Position requires 3-6 years of quality management experience.

• Good experience into customer & supplier audit and able to conduct training

• ISO 13845 experience will be added advantage.

• Demonstrates introductory understanding and ability and with guidance, applies competency in typical situations.

• Able to design quality systems to meet customer expectations and internal needs. New approaches and continuous improvement must be ongoing

• Good interpersonal skills to be able to communicate and collaborate with all stakeholders and deal with situation proactively

• Junior with 1-2 experience in related field can also apply

• Occasionally overseas travel and weekly conference call is required for the role

• This position required to communicate closely with vendors in China.

Mon to Fri 8.30am - 5.30pm

We want to onboard a motivated JAVA Backend QA Automation Tester to join our dynamic team. The ideal candidate will be responsible for ensuring the quality and reliability of our backend systems through automated testing.

RESPONSIBILITIES

• Developed, maintained, and executed automated test scripts for backend systems using Java.
• Collaborate with developers and other QA team members to design and implement test plans, test cases, and test scripts.
• Identify, document, and track bugs and issues found during testing.
• Perform regression, integration, and performance testing of backend services.
• Utilize automation frameworks and tools such as Selenium, TestNG, JUnit, and REST Assured.
• Contribute to the continuous improvement of the QA process, tools, and methodologies.
• Participate in code reviews and provide feedback to ensure testability and quality of code.
• Work closely with cross-functional teams to understand requirements and provide input on testability and quality.
• Ensure compliance with industry standards and best practices

TECHNICAL SKILLS

• Strong knowledge of JAVA programming
• Proven experience in backend testing and automation using Java.
• Strong understanding of software development life cycle (SDLC) and QA methodologies.
• Proficiency in automation tools such as Selenium, TestNG, JUnit, and REST Assured.
• Experience with API testing and tools like Postman or SoapUI.
• Familiarity with version control systems like Git.
• Excellent problem-solving skills and attention to detail.
• Strong communication and collaboration skills.
• Ability to work independently and in a team-oriented environment.
• Testing certifications (ISTQB) are a plus

Job Description:

1. Quality Management System Maintenance: Ensure the organization’s Quality Management System (QMS) complies with regulatory requirements, including MOH Healthcare Services Act and relevant regulations specific to the company’s services and products.
   Maintain and ensure compliance with accreditation and certification standards such as AABB (Association for the Advancement of Blood & Biotherapies), FACT (Foundation for the Accreditation of Cellular Therapy), and GDP-MDS SS 620 (Good Distribution Practice for Medical Devices), among others.
   
2. Regulatory and Accreditation Compliance:Implement and maintain the necessary requirements for AABB, FACT, and MOH license guidelines.
   Assist in managing deviations and non-conformances (CAPA), including root cause analysis, corrective actions, and process improvement.
   
3. Auditing and Compliance:Conduct internal audits and record checks to ensure ongoing compliance with regulatory and accreditation standards.
   Provide support for external audits as necessary.
   
4. Document Control System:Manage the Document Control system for the organization, ensuring the proper use of controlled and approved documents by all staff.
   
5. Supplier and Vendor Management:Support supplier/vendor qualification processes and conduct audits as required.
   
6. Change Control and Quality Monitoring:Assist in managing change control activities across the organization.
   Monitor and review quality indicators and quality control reports across various departments to ensure continual improvement and adherence to quality standards.
   

Requirements:

• Educational Background:Degree in a relevant field with at least 3 years of experience in Quality Systems, preferably within the healthcare, bio/pharma, health services, or biotechnology/biotherapies industry.
  
• Skills and Competencies:Strong communication skills with the ability to convey information clearly.
  Team player with excellent coordination skills.
  Meticulous, analytical, and systematic in approach to tasks.
  Experience in Quality Assurance within regulated industries is highly valued.
  
• Additional Consideration:Candidates with more extensive experience may be considered for the Assistant Manager role.
  

Interested applicants are welcome to submit your MS Word resume to:

[email protected]

EA Personnel: R1109773

EA Licence: 07C3676

Requirements

• Degree with at least 3 years of working experience in Quality System (preferably in Healthcare, Bio/Pharma, Health Services, biotechnology/biotherapies related industry)
• Good communication skills
• Team player with good coordination
• Meticulous, analytical and systematic
• Candidates with more experience will be considered for a Assistant Manager role

Descriptions

• Maintenance of organization’s quality management system in compliance to:

- regulatory requirements; MOH Healthcare Services Act and other regulatory relevant to the company’s services and products

- accreditation and certification standards; AABB (Association for the Advancement of Blood & Biotherapies), FACT (Foundation for the Accreditation of Cellular Therapy), GDP-MDS SS 620 (Good Distribution Practice for Medical Devices) and other standards when required for the company’s services/products

• Ensure requirements for AABB, FACT as well as MOH license guidelines are implemented and maintained
• Follow up and assist in deviations/ non-conformances (CAPA) for root cause analysis, rectification and process improvement
• Performance of Internal Audits and record checking and support External Audit to ensure compliance with regulatory and accreditation standards.
• Manage the Document Control system for the organization and ensure staff complies with the use of controlled and approved documents.
• Support supplier/ vendor qualification and audits
• Support change control activities
• Responsible for maintaining Quality Systems in the company.
• Responsible for monitoring and reviewing quality indicators and quality control reports across departments.

• 5 years Gray box QA
• Proven experience black box testing Client-Server products with a focus on Server/API testing
• Demonstrated ability to write automation - we currently use Python
• Experience testing RESTful APIs
• Proficiency in an object-oriented language like C#, Java, JavaScript, Perl, Ruby, or Swift
• Experience traversing Unix directory structures; use basic Unix commands to scrape log files
• Experience scrapping customer logs and web searches to design tests cases as end user would use it
• Acquaintance with continuous integration/deployment
• Familiarity with static code analysis tools
• Experience with basic database queries

Job Description

1. Maintain, monitor the implementation & update of relevant audit programs
2. Provide technical advice & support various departments
3. Conduct compliance inspections in production floor & warehouse, identifying key areas for improvements and advice corrective actions
4. Perform QA inspections for incoming/outgoing cargoes based on compliance requirements
5. Coordinate with suppliers to resolve non-conformances
6. Provide in-house training on compliance etc for various departments

Job Requirement

• Diploma in Food Science/Food Technology or related disciplines
• Strong knowledge in food safety, well verse in GMP/GWP
• Strong analytical & problem solving skills
• Excellent interpersonal & communication skills

Job Summary

The QA Manager is responsible for overseeing and managing the quality assurance team, ensuring that all products and services meet organizational standards and customer expectations. The role involves developing and implementing quality assurance processes, leading a team of QA professionals, and collaborating with cross-functional teams to drive continuous improvement in product quality.

Key Tasks:

· Ensure food safety and quality systems (eg. ISO 22000, GMP)

· Execute and monitor procedures related to daily production

· Monitor process flows and ensure its compliance to established parameters

· Evaluate the services of sub-contracted service, for example pest control, cleaning

contractors, etc.

· Plan and monitor shelf life studies for current and new products

· Liaise directly with customers on customer complaints or food safety issues, feedback

· Conduct ISO 22000, GMP and local food authorities’ requirements (AVA/MUIS)

training for relevant staff

· Ensure product consistency

· Work with R&D and production to ensure smooth execution of new products

developed to mass production

· Handle food safety audits by customers, AVA

· Conduct risk assessment profiling for products, ingredients and product contact

materials

Skills & Competencies:

· Diploma/ Degree in Food Science and Technology, Food Nutrition and Dietetics

· Completed ISO, HACCP and/or Risk Management course

· Minimum 6 to 8 years of working experience in food manufacturing environment

· Experience in ISO, HACCP, Risk Management and GMP is an advantage

· Proactive, resourceful and adaptable

· Ability to multi-task and work under pressure

· Good Communications, interpersonal and team interaction skills

· Good diplomacy (to liaise with external parties such as AVA customers, vendors and

other government bodies)

Industrial Quality Engineer

Yishun, Singapore

Who We Are:

Lumileds is a global leader in LED and microLED technology, innovation, and solutions for the automotive, display, illumination, mobile, and other markets where light sources are essential. Our approximately 3,500 employees operate in over 15 countries and partner with our customers to deliver never before possible solutions for lighting, safety, and well-being.

The Lumileds environment is fast-paced, cutting-edge, intelligent and fun! We are looking for exceptional talent to join our team! To learn more, visit lumileds.com.

Who You Are:

We are looking for someone who is interested in Quality functions and is an advocate for Continual Improvements. We are seeking a self-motivated person to take on the role of an Industrial Quality Engineer.

What You Will Do:

· Understanding of Product Design, Materials and Wafer Fab/Thin Film Flip-Chip process.

· Learn and Apply Quality Principles and Automotive Core Tools (APQP,FMEA, SPC, MSA,PPAP).

· Provide comprehensive daily support to QA Operations (Incoming and Outgoing Inspection) and work closely within/inter-departments on issues related to Detection and Defectivity.

· Manage Tools/Equipment for Calibration, Repair and Maintenance

· Take on Operation Performance Metrics for timely reporting.

· Work with various functional teams on Identified Automation opportunities for QA Operations.

· Support Total Continuous Process Improvement and Innovation (TCPII) activities for Site.

What You Will Bring (REQUIRED Qualifications):

· Team-Player and Effective communication skills are desired.

Education (Minimum Level)

· Bachelor's

Field of Study

· Electronics/Mechanical/Electrical or Material Science or relevant.

Years of Experience (Minimum)

· 1 - 3 years

Preferred Qualifications:

· Understanding Semiconductor and Light-Emitting Diode (LED) device and process is a plus.

Lumileds is an Equal Employment Opportunity Employer

Areas of Responsibility:

1. EduTrust

· Spearhead the entire EduTrust certification and renewal process, ensuring successful preparation and coordination for site assessments.

· Provide clear guidance to process owners on meeting EduTrust requirements and maintaining alignment with Policy and Operations Manual (POM) standards.

· Act as the custodian of all controlled documents, ensuring timely updates and consistent document control, including Policy and Operations Manuals.

· Collaborate with process owners to review and enhance policies and SOPs, ensuring alignment with EduTrust criteria and operational effectiveness.

· Conduct thorough internal assessments as part of the QA team to monitor compliance and identify areas for continuous improvement.

· Analyse performance data, audit findings, and compliance trends to identify gaps and recommend improvements.

· Support the development of internal benchmarks and evaluate organisational performance against relevant industry and regulatory standards.

2. ERF

· Ensure timely and accurate submissions related to SkillsFuture Singapore (SSG) registrations, including updates for Managers, Academic & Examination Board (AEB) members, courses, and premises.

· Coordinate the submission of PEI Annual Returns, ensuring completeness and adherence to regulatory deadlines.

· Assist in the preparation and execution of ERF renewal exercises to maintain compliance and secure re-certification.

· Maintain organised and up-to-date documentation, ensuring records are easily accessible and audit-ready.

Requirements:

• Minimum Diploma or Degree in a relevant field.
• At least three years of experience as a QA Manager in a Private Education Institution (PEI).
• Proven track record of having led at least one full EduTrust certification or renewal assessment.
• Strong understanding of EduTrust and ERF requirements, including compliance standards, internal assessments, and documentation practices.
• Ability to perform data analysis, interpret trends, and derive meaningful insights to support benchmarking and decision-making.
• Familiarity with establishing and monitoring internal benchmarks to support continuous improvement and regulatory compliance.

Job Description:

• Lead and guide sub-contractor to achieve quality workmanship
• Handle paperworks , defects issuance and reporting
• Conduct defects investigation and identification

Job Requirement:

• Minimum 4 years in CONQUAS
• Possess at least 2 good industry practices certificates
• Microsoft office knowledge
• Able to communicate with client and consultant

We are seeking a dedicated professional to champion quality assurance and testing practices, driving impactful change and ensuring the delivery of robust, user-centric solutions.

What to Expect:

• Define and maintain QA and Testing processes, including Test Management, Defects Management and Code Quality
• Coach and mentor IT Business Analysts and end users on QA and testing processes, fostering a culture of quality and excellence within IT teams.
• Work with selected projects, championing product quality and software testing practices in agile/waterfall project delivery.

How to Succeed:

• Degree in software engineering, computer engineering, electrical engineering, or related discipline.
• Minimum 5 years of experience in establishing test strategies for systems in agile development environments.
• Profound knowledge of various test types, levels, techniques, methodologies, and test automation, with a strong understanding of test-driven development and continuous integration/delivery principles.
• Hands-on test automation experience and the ability to integrate test automation into the Continuous Integration chain.
• Experience in QA Management for the system delivery and Certification in Testing and Software Quality Assurance will be a bonus.
• Organized, methodical, and meticulous in planning, management, and execution, with a strong focus on attention to detail and problem-solving.
• A team player who is self-motivated, proactive, and customer-oriented, with excellent communication and presentation skills.

Key Responsibilities

Functional and Automation testing experience including tools such as Selenium, UFT, JIRA, Postman

• Degree in software engineering, computer engineering, electrical engineering or infocomm-related discipline
• Must have professional software quality testing experience with hands-on automation
• Strong understanding of testing techniques, risk analysis
• Strong understanding of test-driven development, continuous integration and continuous delivery
• Experience with automation scripting (i.e. Python and shell scripts)
• Experience with open-source automated testing frameworks (i.e. RobotFramework, Selenium Webdriver)
• Experience with open-source performance testing tools (i.e. JMeter, Gatling, Locust) or enterprise level testing tools (HP LoadRunner)
• Experience with open-source penetration testing tools (ZAP, Burp Suite, SQL Map) or enterprise level penetration testing tools (HP WebInspect, Nessus, CheckMarx)
• Working experience in Agile environment will be an added advantage
• Excellent verbal communication and listening skills
• Proactive, self-driven and motivated

Responsibilities

§ Planning and driving of newly set-up office, developing necessary approval papers and documents, establishing new department processes, including timeline management, stakeholder engagement, tracking of project progress and deliverables.

§ Lead and develop innovation capabilities and implement new innovations into the culture to influence the overall operations.

§ Facilitate Quality Improvement and Innovation workshops such as lean and human-centred tools to impart knowledge and skills to hospital staff.

Requirements

· Bachelor’s Degree Business Analytics/Computer Science/Engineering/Business Administration or related fields.

· Ability to leverage technology solutions to support quality improvement initiatives.

· Proficient in programming tools such as Python and RPA and good understanding of AI tools to help boost productivity.

· Proficient in LEAN/Six Sigma/AGILE/Design Thinking/Behavioural Insights preferred.

· Certified Train-the-trainer (ACTA/ACLP) or equivalent preferred.

To find out more about this opportunity, please contact Lionel Liew at [email protected].

We regret that only shortlisted candidates will be notified.

GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Lionel Liew | Registration No: R1330693

This is in partnership with the Employment and Employability Institute Pte Ltd (“e2i”).

e2i is the empowering network for workers and employers seeking employment and employability solutions. e2i serves as a bridge between workers and employers, connecting with workers to offer job security through job-matching, career guidance and skills upgrading services, and partnering employers to address their manpower needs through recruitment, training, and job redesign solutions. e2i is a tripartite initiative of the National Trades Union Congress set up to support nation-wide manpower and skills upgrading initiatives.

By applying for this role, you consent to GMP Technologies (S) Pte Ltd’s PDPAand e2i’s PDPA.

• Develop, implement and maintain quality assurance standards and procedures for our central kitchen in line with company goals and industry best practices
• Conduct regular audits and inspections of kitchen operational processes to ensure compliance with food safety, hygiene and quality standards
• Investigate food quality issues and customer complaints, determine root causes and implement corrective actions.
• Collaborate with operation heads and staff to ensure food quality standards are upheld consistently across all outlets and brands.
• Work with suppliers and vendors to ensure that food ingredients meet quality specifications
• Attend scheduled departmental meetings and prepare monthly food quality assurance reports
• Proactive, insightful, independent thinker, highly efficient and possesses a refined attention to detail
• Have at least 3 years of F&B experience in a supervisory role

Responsibilities

• Environmental Quality Audit, that comprises of the following inspection units:
• Entrance and lobby, lift cars, planter boxes and containers, porches, pavement, aprons, sidewalks, external game courts, carpark, driveway, hard standing, loading and unloading bay, field, gardens, side tables, bin centre / bin chute.
• 50% of the following inspection units: classrooms, lecture halls, auditoriums, laboratories, offices, staff rooms, special rooms, rooftop, common staircase / landings / steps / common areas, toilets, external compound and handrails.
• During each Environmental Quality Audit, representatives shall be present to validate that all documentations submissions are in order.
• To follow-up of Environmental Quality Audit findings, gaps identified and recommendations till close out.
• To ensure consistent remarks, comments and assessment standard for all sites during the Environmental Quality Audit in the Environmental Quality Audit report.
• To use the electronic cleaning audit system, device and forms

Requirements

The Environmental Quality Auditor(s) shall possess the following competency and experience:

• Possess WSQ Advanced Certificate in Environmental Cleaning/Services for cleaning supervisor or possess a relevant WSQ Qualification or equivalent in cleaning supervision; and
• Possess valid Environmental Control Coordinator (“ECC”) license.
• Preferably 3 years in cleaning supervision or cleaning auditor; and
• Preferably 1 year as certified ECC practitioner.

You will be a member of the quality assurance team under the product design and development pillar. You will be involved in the end-to-end agile development lifecycle for in-house projects starting from UI/ UX Design to Software Development, Cloud Engineering & Operations, DevSecOps, Quality Assurance and Application Security.

Key responsibilities

• Work with the Business Analyst and UI/ UX Designer as they engage the Product Owner and stakeholders for requirements gathering and user research to produce the User Journey Maps and high-fidelity wireframes, which feeds into development sprints
• Prepare test cases for both front and back-end as well as entry and exit criteria for SIT and UAT to ensure that user requirements are met as described in the product backlog
• Conduct testing for both front and back-end test cases in every development sprint using a myriad of tools such as postman for API testing
• Create, maintain and update test scripts and pipelines for automated testing framework on the selected DevSecOps platform and toolchain i.e. Azure DevOps Center and Katalon
• Develop documentation for quality assurance rules, policies, procedures and guidelines (RPPG) to guide future projects
• Identify best practices and continuous improvement in quality assurance processes

Requirements

• Background in Computer Science, Engineering or related disciplines.
• Highly proficient in quality assurance processes and methodology.
• Technical knowledge and experience working with DevSecOps platforms and toolchains such as Katalon and Selenium is preferred.
• Participated in at least one full software or product development cycle, preferably using Agile Methodology
• Excellent communication skills
• Teamwork and collaboration skills
• Possess critical thinking and problem-solving skills

You may be offered a 2-year contract in the first instance.

Objectives of the position:

This role is for the validation of Customer technical requirements by means of inspection of In-coming goods and release lots in SAP with defined usage decisions. Testing of ISIR samples (type test) for product approval process (power, control & data cable) with compliance to company standards and verify compliance to the international cable standards e.g. EN / IEC requirements. Understanding of each testing standards and be able to communicate the requirements to respective parties including suppliers. Establish test specification to be followed by suppliers. To be able to operate all laboratory equipment in the process of cable type testing. Keep track of product approvals and Company's approved suppliers’ performance monitoring to ensure continuous product compliance to the intended specification. Corrective and preventive action process with supplier with CAR logging and follow-up for effective closure of complaints and issues related to product quality.

Knowledge in product testing and certification will be an added advantage.

Key Responsibilities:

1. Validate product quality conformance by conducting In-coming inspection and type testing for cable & accessories, include updating into SAP.

2. To be able to operate Laboratory test equipment for cable testing and accessories inspection

3. Understand international cable testing standards and inspection requirements with compliance to internal ISO procedures. Prepare test specification with detailed inspection requirement to be followed by the supplier.

4. Prepare and issue Customer test reports, certificates & COC

5. Track supplier quality by means of in-coming inspection or arise from Customer complaints. Update results in SAP system and release inspected lots according to the usage decision defined.

6. To generate supplier CAR and track for corrective action and effective closure of CARs by liaising with the supplier.

7. Liaising with relevant departments including suppliers to effectively close the CAR issued for Customer complaints or CAR’s which arise from internal findings (Z2 & Z8).

8. Maintain inspection records in SAP, determine skip lot and setup inspection requirements in SAP.

9. Assist Customer’s Technical enquiries e.g. Customer letter, RoHS, REACH & CE

10. Understand and comply with relevant ISO procedures, work instructions and corporate directives

11. Assist in other day to day activities related to QA department as assigned by superior.

12. Contribute to achieving company, department and personal KPIs through due diligence, duty of care & personal accountability for Quality assurance in all tasks.

Skills & Qualification:

▪ Min. Diploma or Degree in Engineering (Electronics / Electrical) or equivalent

▪ Min. 2 years’ experience in electrical / electronic product testing and qualification.

▪ Knowledge in ISO 9001:2015 QMS standard will be added advantage.

▪ To be able to operate lab equipment e.g. calliper, visual scope, resistance checker, High voltage tester etc.

▪ Prior experience in SAP system and knowledge of cable product testing is an added advantage

▪ Good written and communication skills

▪ Good customer handling skills and able to communicate to all levels in the organization

▪ Proficient in Microsoft Words and Excel

▪ Addresses present issues immediately and independently

▪ Possess self-confident and willing to share opinions and expertise in discussions

▪ Anticipate potential problems and takes action to avoid crisis

▪ Provide support to colleague in the Department and work as a team to achieve Department goals and targets

Mon to Fri 8.30am - 5.30pm

PM Singapore is currently looking to expand the CQV capabilities. This role will be supporting one of our many clients in the field of commissioning, qualification and validation work within the Life Sciences space.

Your day to day role would involve the following activities:

• Planning, Performance, and Coordination of Computer System Validation, Equipment Qualification, Temperature Controlled Objects (Freezers, Incubator etc), Clean Utilities Validation and cleaning validation in accordance with internal procedures and industry standards.
• The qualification includes, FAT, SAT, IQ, OQ, PQ of any additional modifications of existing manufacturing process equipment, package units (e.g. Ultrafiltration Unit, Chromatography Columns, autoclave, FIT testers), commercial off the shelves (COTS) analytical instruments, freezers,
• Create, review and approve equipment qualification and analytical instruments lifecycle documentations, e.g. FAT, SAT, IQ, OQ, PQ protocols and reports, risk assessments, technical specifications.
• Can lead investigation revolving around discrepancies identified during qualification activities.

We would like to hear from candidates who have:

• Min 10 years of relevant experience in validation activities (including the creation, pre-execution approval, execution, post-execution review, and post-execution approval of all validation lifecycle documents)
• Leading daily validation meetings with cross functional teams in resolving validation issues.
• Experience in equipment qualification including analytical instrumentation and manufacturing equipment.
• Work experience in Pharmaceutical or BioPharma industries
• Hands on validation execution experience
• Able to execute activities in cGMP environment, including cleanrooms or technical areas.

Objectives of the position:

This role is for the validation of Customer technical requirements by means of inspection of In-coming goods and release lots in SAP with defined usage decisions. Testing of ISIR samples (type test) for product approval process (power, control & data cable) with compliance to company standards and verify compliance to the international cable standards e.g. EN / IEC requirements. Understanding of each testing standards and be able to communicate the requirements to respective parties including suppliers. Establish test specification to be followed by suppliers. To be able to operate all laboratory equipment in the process of cable type testing. Keep track of product approvals and Company's approved suppliers’ performance monitoring to ensure continuous product compliance to the intended specification. Corrective and preventive action process with supplier with CAR logging and follow-up for effective closure of complaints and issues related to product quality.

Knowledge in product testing and certification will be an added advantage.

Key Responsibilities:

1. Validate product quality conformance by conducting In-coming inspection and type testing for cable & accessories, include updating into SAP.

2. To be able to operate Laboratory test equipment for cable testing and accessories inspection

3. Understand international cable testing standards and inspection requirements with compliance to internal ISO procedures. Prepare test specification with detailed inspection requirement to be followed by the supplier.

4. Prepare and issue Customer test reports, certificates & COC

5. Track supplier quality by means of in-coming inspection or arise from Customer complaints. Update results in SAP system and release inspected lots according to the usage decision defined.

6. To generate supplier CAR and track for corrective action and effective closure of CARs by liaising with the supplier.

7. Liaising with relevant departments including suppliers to effectively close the CAR issued for Customer complaints or CAR’s which arise from internal findings (Z2 & Z8).

8. Maintain inspection records in SAP, determine skip lot and setup inspection requirements in SAP.

9. Assist Customer’s Technical enquiries e.g. Customer letter, RoHS, REACH & CE

10. Understand and comply with relevant ISO procedures, work instructions and corporate directives

11. Assist in other day to day activities related to QA department as assigned by superior.

12. Contribute to achieving company, department and personal KPIs through due diligence, duty of care & personal accountability for Quality assurance in all tasks.

Skills & Qualification:

▪ Min. Diploma or Degree in Engineering (Electronics / Electrical) or equivalent

▪ Min. 2 years’ experience in electrical / electronic product testing and qualification.

▪ Knowledge in ISO 9001:2015 QMS standard will be added advantage.

▪ To be able to operate lab equipment e.g. calliper, visual scope, resistance checker, High voltage tester etc.

▪ Prior experience in SAP system and knowledge of cable product testing is an added advantage

▪ Good written and communication skills

▪ Good customer handling skills and able to communicate to all levels in the organization

▪ Proficient in Microsoft Words and Excel

▪ Addresses present issues immediately and independently

▪ Possess self-confident and willing to share opinions and expertise in discussions

▪ Anticipate potential problems and takes action to avoid crisis

▪ Provide support to colleague in the Department and work as a team to achieve Department goals and targets

Mon to Fri 8.30am - 5.30pm

Description:

• Review and analyse requirements, specifications, and technical design documents to provide timely and constructive feedback.
• Develop detailed, comprehensive, and well-structured test plans and test cases that adhere to industry standards.
• Effectively estimate, prioritize, plan, and coordinate testing activities to ensure comprehensive test coverage.
• Design, develop, and execute automated testing scripts utilizing reliable automated testing tools.
• Identify, document, and meticulously track defects, ensuring prompt resolution and thorough regression testing.
• Monitor the debugging process and track quality assurance metrics, including defect densities and open defect counts, to maintain high quality standards.
• Stay informed about emerging testing tools and methodologies to enhance testing effectiveness.
• Collaborate closely with development and project management teams to facilitate smooth SIT and UAT processes.

Job Requirement:

• Bachelor's degree in Computer Science, Engineering, or related field.
• Experience in software quality assurance is essential, demonstrating a strong understanding of QA methodologies, tools, and processes.
• The ability to develop clear, concise, and comprehensive test plans and test cases is also critical.
• Familiarity with Agile and Scrum development methodologies is highly regarded.

The Position

• The In-Market Quality, AP(SG/ID/VN/HK) Lead reports to AP In-Market Quality Lead.
• The incumbent is a leader of a team of 2-3 quality professionals responsible for In-Market Quality activities and maintains the affiliates within the cluster of countries in scope, in a state of GDP (and where applicable, GMP) compliance.
• The incumbent provides overall leadership and direction, coaching and training to the local In-Market Quality team; ensures that appropriate Quality Systems are established, implemented and maintained in each market in scope, and appropriate oversight is in place to ensure that local regulatory requirements are compliant and can be supported in a simple, cost effective manner, while working within the bounds of the global Quality Management System.
• The incumbent liaise with Global Quality, External Manufacturing Quality, the Quality Units of the manufacturing network, Regulatory Affairs / Pharmacovigilance and Supply Chain to support the commercial activities while maintaining Quality and Compliance.

Responsibilities:

• Responsible for the strategy, leadership, management and budgetary controls of a multi-cultural team of Quality professionals.
• Holds Employee Development Plan discussions and is responsible for executing the performance management process.
• Contributes to the development of the AP IMQ budget and tracks and controls expenses as needed to meet AP IMQ budget.
• Exhibits our company Leadership Behaviors and provides a leadership example for the team.
• Works strategically and in collaboration with other functions to continuously improve our company`s effectiveness and efficiency in quality management and quality systems supporting AP IMQ function.
• Ensure alignment of Indonesia, Singapore, Hong Kong and Vietnam market with applicable global GDP/GMP regulations, global quality systems and with agency expectations.
• Establish and maintain strong partnerships with key global/regional colleagues and teams that impact Quality and Compliance.
• Ensure deployment and implementation of new / revised QMS policies, standards and global SOPs.
• Establish performance management processes to monitor compliance and continuous quality improvements.
• Provide leadership and oversight for Significant Investigations, Fact Findings, HA notifications and Market Actions.
• Drive the development, implementation and realization of Permanent Inspection Readiness in collaboration with key stakeholders.

Required Education, Experience and Skills:

• Bachelor or Masters Degree in Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering (or equivalent)
• Solid knowledge of global cGDPs/GMPs relevant to Marketing Authorizatin Holders and countries in scope
• Strong compliance mindset, excellent project management and organizations skills
• Excellent problem-solving skills, based on science, facts, data and understanding of regulatory requirements in complex and evolving environments; must be able to apply sound risk management principles
• Ability to be decisive and influence management with demonstrated leadership skills to drive change
• Ability to work collaboratively in team settings, across functions, and within matrix organisations to achieve objectives
• Strong commitment to diversity and employee development
• Strong demonstrated interpersonal, communication, collaborative and leadership skills in dealing with a broad variety of cultures
• Demonstrated ability to create simplicity out of complex environments and challenges Minimum

Preferred Education, Experience and Skills:

• Minimum of 5 years' experience in the pharmaceutical industry, with solid compliance experience.
• Must have expertise and broad experience in Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GDP and regulatory requirements.

Job Summary

Responsible for management of Asia Quality System, Policies, Programs and Initiatives. Part of the Global Quality Team to maintain global quality system and drive global initiative.

Role and Responsibilities

Quality Systems

1. Supports overall maintenance of quality systems

2. Monitor and reports on the quality performance for Asia Operations such as product quality performance, supplier performance and gaps for continuous improvement to the management team

3. Maintains the Master control and ISO document control system

4. Maintains customer related documents such as Quality Agreement, PPAP

5. Part of the Global Quality Team, to design and implementation of global policies and systems

Quality Policies

6. Ensures effective implementation of all company quality policies

7. Implements ISO and other recognized standards

8. Implements and monitors statistical techniques such as R&R’s to identify opportunities for improvement.

9. Sets, communicates, and implements quality objectives in line with business goals

10. Manage supplier and customer programs (CCAR, ICAR and SCARs) to ensure that complaints are handled effectively and timely.

11. Support and work with different stakeholders on reporting, monitoring and resolution on customer complaints.

12. Support and work with Supply Chain and Operation on supplier quality issues.

Auditing

13. Leads ISO quality standards implementation as Management Representative.

14. Conducts and leads quality audits to specific quality standards.

15. Leads customer related audits

16. Conducts supplier audits

17. Conducts internal audit investigations for product quality and process issues

18. Responsible for ensuring timely resolution to audit findings

Training

19. Provides training for all employees on basic quality and statistical concepts

20. Provides training to appropriate personnel for updates and changes to quality policy

21. Attends relevant external training sessions/courses and shares learning internally

Job Requirements:

• Degree or equivalent experience in a field of study such as chemistry, business, accounting, engineering, etc.

• Certificate in Quality Engineering is preferred.

• Position requires 3-6 years of quality management experience.

• Good experience into customer & supplier audit and able to conduct training

• ISO 13845 experience will be added advantage.

• Demonstrates introductory understanding and ability and with guidance, applies competency in typical situations.

• Able to design quality systems to meet customer expectations and internal needs. New approaches and continuous improvement must be ongoing

• Good interpersonal skills to be able to communicate and collaborate with all stakeholders and deal with situation proactively

• Junior with 1-2 experience in related field can also apply

• Occasionally overseas travel and weekly conference call is required for the role

• This position required to communicate closely with vendors in China.

Mon to Fri 8.30am - 5.30pm

Quality Technician (Jurong Island)

Responsibilities

• Support production shift team with sample testing
• Cleaning and preparation of sampling apparatus, Ampule, gel bottles and other laboratory glassware.
• Prepare reagent and standard sample for analytical equipment.
• Report abnormalities and support troubleshooting of equipment.
• Review and revise for QC process flow, control plan and SOP of analytical such as non-prime product, process problems and complain.
• Investigate root cause and take corrective action plan.
• Planning for analytical process modification and analytical process change.

Requirements

• Min NITEC or Diploma in Chemical Engineering field or other relevant certificates
• Possess Analytical knowledge and Skills such as gas chromatography, gel permeation chromatography, Fourier infrared analysis, gel analysis, Karl Fischer’s method and titration method) are preferred
• Highly motivated, a team player, with the ability to multitask and project management skills
• Understand quality policy and basic rule.

Interested applicants please submit your resume to [email protected]

You’ll get to:

• As a Quality Engineer, you have the opportunity to accelerate the delivery and to improve the quality of the software we build through recommending and implementing automated test suites.
• Work with the supporting vendors, agencies and teams to identify end-to-end test scenarios as well as to automate these test scenarios, applying risk-based strategy to minimize manual interventions.
• Conduct research on emerging technologies that can optimize and accelerate the project delivery.
• Ensure all required testing documentation are in place as part of production preparation checks.
• Drive and advocate continuous improvement in testing practices and tools.

What you’ll bring to the team:

• Degree or Diploma in Computer Science, Computer or Electronics Engineering, Information Technology, or related disciplines
• Minimum 3 years' experience in application exploratory testing and regression test automation
• Understanding of Web-based project test methodology, test environments, bug life cycle, and frequent code release deployment QA support
• Create, review and/or support test automation strategies and implementations
• Experience working with highly trafficked, scalable Web applications
• Troubleshooting/debugging skills
• Meticulous attention to details
• Good analytical, interpersonal and presentation skills
• Keen to share knowledge with team mates
• Curious, open to new ideas
• Quick to learn new skills
• Proactive, self-driven and motivated

Bonus points for:

• ISTQB, CSQA, CSTP or other relevant certification
• Experience with Katalon Recorder and/or Katalon Studio or equivalent
• Advanced knowledge of common desktop and mobile browser technology