• Well Established Company
• Basic $5000 - $6500 + Allowance + AWS + Variable Bonus
• Excellent Welfare and Benefits + Career progression
• Working location: Boon Lay
• Working day: Monday to Friday
• Working hours: 8.30am to 5.30pm
• QMS | ISO 13485 | Medical Devices

Job Responsibilities:

• Conduct assessment and review on supplier qualification, performance and process capability
• Ensure supplier quality issues are deal with, analysed, improved and follow through
• Collect, handle and follow-up on customer feedback/complaints
• Support internal, external and customer audits
• Evaluation, verification and validation of new parts/samples
• Establish and maintain inspection criteria for incoming, in-process and final products
• Identify quality issues, NCR, CAPA handling and drive continuous improvement
• Authorize the release (COC) of products, COA review & approval
• Monthly data analysis on product quality and quality objective
• Review and approval on DHR
• Participate in new projects, commercial product quality management and control
• Drive change management and control
• Other ad hoc duties as assigned

Job Requirements:

• Possess minimum Diploma/Degree in relevant subject area with 2 years’ experience in medical device QA and/or RA
• ISO 13485:2016 certified internal auditor will be advantageous
• Familiar with quality control tools

Candidates are encouraged to apply this position via Apply Now button with the following information in the resume

• Work experiences and job responsibilities
• Current and Expected salary
• Reason for leaving
• Date of availability
• Education background

We regret that only shortlisted candidates will be contacted.

LIONG ZHAO GUAN (R22107632)

EA Recruitment Pte Ltd

EA License No: 21C0492

Quality Operations Specialists must assist site management to oversee the quality system execution on the manufacturing and production areas at all times.

The personnel are required to observe, document, discuss, and report quality adverse events related to the manufacturing of the product and are responsible to ensure highest quality and compliance of released batches.

Responsibilities:

• Ensure that products manufactured meet approved company policies, processes and procedures.
• Provide quality oversight of GMP manufacturing and manufacturing support, including technical operations, engineering, QC laboratory and supply chain activities.
• Review completed incoming material inspection packages, Batch Records, Manufacturing Logs, product changeover/line-clearance activities and administration of Quality Logs, e.g., QA Hold, QA tag out.
• Release incoming material, process, and product batches.
• Participate in investigations arising out of non-compliance in incoming materials, QC testing, manufacturing processes, warehousing, and product.
• Participate in change management, including change coordinator and/or QA oversight roles to ensure change plan is managed and complies with applicable policies.
• Perform regular walk-through of manufacturing, engineering, warehouse and QC areas as required to ensure compliance is maintained at all times.
• Participate and support new product introduction, operation excellence projects and other tasks as assigned by management.

About You:

• Bachelor Degree in a Natural Sciences (i.e. Biology, Chemistry), Engineering, Pharmacy or other relevant courses.
• Prior knowledge of quality / compliance management as well as regulations and standards affecting APIs / Biologics.
• Minimum of 3 years of pharmaceutical, biopharmaceutical experience in Quality and/or Compliance (GxP) environment.
• Experience in SAP, Trackwise are preferred.
• Ability to quickly know products and processes in order to assess quality issues.
• Committed to quality and maintain a high standard of work at all times.
• Demonstrates the highest levels of integrity and a strong work ethic.
• Good knowledge of GxP requirements and regulations.
• Good planning and scheduling skills.
• Good communication and interpersonal skills both verbal and written.

Contract Period: 12 months, subject to renewal based on performance.

Based in Tuas.

Job Scope

• Responsible to review and approve master batch records and subsequent batch records
• Review and approve cleaning records and procedures and ensure compliance with set
• Review and approve GMP documentation Ensure adherence to quality procedures, regulatory requirements and cGMPs.
• Review and approve deviations according to the site procedures
• Handle product complaints.
• Ensure complaints are investigated thoroughly with CAPAs effective to prevent recurrence.
• Coordinate with cross-functional team to prepare Annual Product Reviews, discuss trends and atypical observations and recommend improvement actions.
• Conduct internal and external audits
• Maintain inspection readiness and support inspections from regulatory agencies and customers.
• Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state.
• Support the maintenance of validated stated of GMP systems and processes.
• Facilitate and prepare regulatory submissions and attend to regulatory queries in a timely manner

Requirements

• Min Degree in Science / Chemical Engineering or equivalent with relevant pharmaceutical experience.
• Minimum 3 relevant years of experience in QA/QC and GMP Compliance
• Familiar with manufacturing operations applications; six sigma and lean principles and process improvement tools.
• Thorough knowledge of GMP compliance regulations, ICH Q7a Guidelines, Good Documentation Practices and other applicable regulations.
• Proven track record of continuous improvement in quality operations or manufacturing.

All qualified applicants, please send in your resume to: [email protected]

Alex Goh Hock Leong (R1763413)

Recruit Express Pte Ltd | Company Reg. No. 199601303W | EA License Number: 99C4599

As an intern for the Assurance, your responsibilities include:

• Working as part of an audit team to complete, or assist in the completion of audit tasks which includes financial and statutory audits of companies
• Assist the team to perform analytical review of audit documents
• Assist the team with the preparation of supporting documents to support the opinion in the financial statements
• Assist the team with vouching of audit documents
• Assist the team to preform statutory reviews
• Assist the team to perform administrative works such as referencing, casting, indexing, etc.

Requirments:

• Training will be provided
• You must be a Singaporean or SPR, and able to commit for at least 3 months

Objectives of the position:

This role is for the Customer Quality Support for Company’s product distribution where Customer’s feedback & Product Quality requirements / issues are handled. The person will be responsible to handle Customers requirements such as complaints, test data & other technical information as requested. Customer complaints handling will also include the necessary communication with all the stake holders (Customer, Supplier, CS, PP, SVM, LOG). Knowledge in cable testing and specification requirements will be required to understand Customer complaints (technical & logistics).

Key Responsibilities:

1. Manage Customer complaint processes such as acknowledgement of the complaint, updating into SAP, keeping track of the complaint, closure of the complaint & summarizing for monthly reporting. Proper handling of customers’ needs by providing accurate and timely information on enquiries related to cable standards, test reports and handling of customer complaints.

2. Track supplier quality by means of in-coming inspection when required or arise from Customer complaints. Update results in SAP system and release inspected lots according to the usage decision defined. To generate supplier CAR and track for corrective action by liaising with the supplier.

3. Familiar with and comply to international cable testing standards and procedures. Contribute to achieving company & department KPIs through due diligence, duty of care & personal accountability for Quality assurance in all tasks.

4. Liaising with relevant departments to effectively close the Customer complaints

5. Maintain records in SAP

6. Operate Laboratory test equipment when required

7. Assist Customer’s Technical enquiries e.g Product Test Report, RoHS, REACH, CE

8. Supplier claim processes and 8D report.

9. Prepare and issue Customer Test Certificates & COC

10. Assist in other day to day activities related to QA department as assigned by Superior.

Skills & Qualification:

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

▪ Min. 2 years’ experience in electrical / electronic product testing and qualification. Training will be provided.

▪ Knowledge in ISO 9001 : 2015 QMS standard.

▪ Must be able to operate lab equipment (calliper, visual scope, resistance checker, High voltage tester).

▪ Prior experience in SAP system is required for this role. 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

Responsibilities:

• Manage internal and external excursions (MRB or Quality Claims).
• Oversee customer data reporting.
• Conduct quality-related training sessions.
• Support customer surveys and audits.
• Lead continuous improvement activities.
• Perform other ad hoc duties as assigned.

Requirements:

• Degree in Engineering or equivalent.
• Preferably knowledgeable in Statistical Process Control (SPC) and statistical techniques.
• Auditing experience is a plus.
• Understanding of system flow and databases is an added advantage.

______________________________________________________

HOW TO APPLY :

Interested candidates, please submit your resume by clicking on “Quick Apply” or contact [email protected] for more details.

Please provide following information in the resume for immediate processing

1) Reasons for leaving current and/or last employment

2) Last drawn and/or current salary

3) Expected salary

4) Date of availability and/or Notice Period

All applications will be treated in strictest confidence and only shortlisted candidates will be notified

Wee Wai Dan

EA License No : 03C5391

EA Reg No : R22109628

About Cynapse

Cynapse is an awarded AI Software Product company specializing in Enterprise-grade Vision AI in highly challenging environments. Our software platform is leveraging cutting-edge cloud/on-premises/edge platforms, advanced computer vision algos, advanced ML concepts & models and more.

The company is led by globally renowned experts who previously headed large groups at Microsoft and Intel. The company HQ is located in Singapore (One North Area) and operates in over 10 countries.

Cynapse is looking for a talented and highly motivated Project Management Officer (PMO)/Quality Assurance (QA) Intern to join our team that delivers challenging, enterprise-scale Video Content Analytics solutions to global customers. You will conform to high standards of project planning and management, working in a cutting-edge, dynamic and professionally challenging environment.

Successful interns may be offered a full-time permanent position at cynapse at the end of the internship period.

Responsibilities
The selected candidate will be involved in one or more job items listed below, depending on management decision:

• Supporting the planning and delivery of Vision AI Software Projects/Programs in Singapore and other countries
• Support multiple ongoing projects
• Assist with the project planning, resourcing and scheduling
• Assist in ensuring that projects are delivered on time, and provide timely reports on project status and activities Assist in requirements gathering and validation, solution development and testing, deployment, UAT and solution commissioning
• With guidance, perform usage tests on software thoroughly, identifying bugs and defects.
• Evaluate different functionalities and aspects of the product and generate reports.
• Assist in communicating and managing vendors, sub-contractors, partners and other stakeholders
• Follow the company PM best practices
• Work in an Agile environment (SCRUM)

Qualifications

• Completed at least 1 year of studies as part of a Diploma/Bachelor/Master in one of the following subjects: IT/Engineering/project management
• At least 6 months of experience in managing or delivering IT project/s
• Some Experience with vendors and partner management
• Analytical Thinking
• Innovative, motivated and a quick learner, attention to detail, curiosity, and passion for technology
• Bonus: Technical background/experience with software development

Benefits

• Unique opportunity to work with a talented global team on cutting-edge technologies
• Informal and exciting work environment with flexible hours

Job Types: Full-time, Internship

Contract length: 6 months

Benefits:

• Flexible schedule

Schedule:

• Monday to Friday

Work Location: In person

Job Responsibilities

• Devising and implementing methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment
• Designing and analysing inspection and testing processes, mechanisms, and equipment
• Conducting quality assurance tests and performing statistical analysis to assess the level of control and manage product quality risks
• Undertaking root cause analysis of incidents requiring corrective action
• Ensure that corrective measures and deviation meet acceptable reliability standards
• Other ad hoc duties assigned

Job Requirements

• API Q1 and Q2 certifications
• Internal audit certification

Interested applicants please send your resumes to [email protected]

Jessica Nguyen Huynh Thanh Truc

Recruiter (R23113787)

EA License No. 99C4599

We regret that only shortlisted candidates will be notified.

Our client is a Global Manufacturing MNC, one of the leading players in the Oil & Gas servicing sector. Due to their current expansion plan, they are looking for a QA Engineer to join their team, in hopes of developing the current high performing team. They are located in the West.

Job Responsibilities

• Responsible for the designing and evaluating processes, mechanisms, and equipment used in inspection and testing.
• Responsible for root cause analyses of incidents that necessitate corrective actions.
• Responsible for quality assurance tests and statistical analyses to assess control levels and manage risks related to product quality
• Ensuring that corrective measures and deviations meet with the standards
• Responsible for the creating and executing methods and procedures for whole process of production equipment (e.g. the inspection, testing, and evaluation of the products).

Requirements

• Min Diploma/Degree in engineering or equivalent
• Min 3 years’ relevant working experience in Quality Management
• Certified in API Q1, Q2, ISO and other relevant auditor would be advantages.

Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/cv.

We regret that only shortlisted candidate will be notified.

Recruitpedia Pte. Ltd.

EA License No. 19C9682

EA Reg. No. R23115553 (Lai Hor Yan)

Our client is a Global Manufacturing MNC, one of the leading players in the Oil & Gas servicing sector. Due to their current expansion plan, they are looking for a QA Engineer to join their team, in hopes of developing the current high performing team. They are located in the West.

Job Responsibilities

• Responsible for the designing and evaluating processes, mechanisms, and equipment used in inspection and testing.
• Responsible for root cause analyses of incidents that necessitate corrective actions.
• Responsible for quality assurance tests and statistical analyses to assess control levels and manage risks related to product quality
• Ensuring that corrective measures and deviations meet with the standards
• Responsible for the creating and executing methods and procedures for whole process of production equipment (e.g. the inspection, testing, and evaluation of the products).

Requirements

• Min Diploma/Degree in engineering or equivalent
• Min 3 years’ relevant working experience in Quality Management
• Certified in API Q1, Q2, ISO and other relevant auditor would be advantages.

Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/cv.

We regret that only shortlisted candidate will be notified.

Recruitpedia Pte. Ltd.

EA License No. 19C9682

EA Reg. No. R23115553 (Lai Hor Yan)

Responsibilities:

• Manage internal and external excursions (MRB or Quality Claims).
• Oversee customer data reporting.
• Conduct quality-related training sessions.
• Support customer surveys and audits.
• Lead continuous improvement activities.
• Perform other ad hoc duties as assigned.

Requirements:

• Degree in Engineering or equivalent.
• Preferably knowledgeable in Statistical Process Control (SPC) and statistical techniques.
• Auditing experience is a plus.
• Understanding of system flow and databases is an added advantage.

______________________________________________________

HOW TO APPLY :

Interested candidates, please submit your resume by clicking on “Quick Apply” or contact [email protected] for more details.

Please provide following information in the resume for immediate processing

1) Reasons for leaving current and/or last employment

2) Last drawn and/or current salary

3) Expected salary

4) Date of availability and/or Notice Period

All applications will be treated in strictest confidence and only shortlisted candidates will be notified

Wee Wai Dan

EA License No : 03C5391

EA Reg No : R22109628

Our client is a Global Manufacturing MNC, one of the leading players in the Oil & Gas servicing sector. Due to their current expansion plan, they are looking for a QA Engineer to join their team, in hopes of developing the current high performing team. They are located in the West.

Job Responsibilities

• Responsible for the designing and evaluating processes, mechanisms, and equipment used in inspection and testing.
• Responsible for root cause analyses of incidents that necessitate corrective actions.
• Responsible for quality assurance tests and statistical analyses to assess control levels and manage risks related to product quality
• Ensuring that corrective measures and deviations meet with the standards
• Responsible for the creating and executing methods and procedures for whole process of production equipment (e.g. the inspection, testing, and evaluation of the products).

Requirements

• Min Diploma/Degree in engineering or equivalent
• Min 3 years’ relevant working experience in Quality Management
• Certified in API Q1, Q2, ISO and other relevant auditor would be advantages.

Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/cv.

We regret that only shortlisted candidate will be notified.

Recruitpedia Pte. Ltd.

EA License No. 19C9682

EA Reg. No. R23115553 (Lai Hor Yan)

Responsibilities

· Implement advanced monitoring systems to ensure product quality and optimize yield.

· Proactively identify areas for improvement and develop strategies to enhance overall product quality.

· Lead initiatives to integrate and improve abnormal quality issues within the manufacturing process.

· Work closely with cross-functional teams to implement effective solutions and preventive measures.

· Drive initiatives to improve internal quality control procedures and enhance overall process capability.

· Implement best practices to streamline processes and maximize operational efficiency.

· Take the lead in addressing and improving customer-reported quality issues.

· Compile comprehensive reports for stakeholders, detailing corrective actions and preventive measures.

Requirements

· Bachelor's degree in a relevant field; advanced degree preferred.

· Proven experience in quality management, with a focus on manufacturing processes.

· Certification in quality management (e.g., Six Sigma) is a plus.

· Available to travel and be based at company’s factory sites at least 12 months for the year.

To apply, please visit to www.gmprecruit.com and search for Job Code: 24641.

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 PDPA and e2i’s PDPA.

Our client is a Global Manufacturing MNC, one of the leading players in the Oil & Gas servicing sector. Due to their current expansion plan, they are looking for a QA Engineer to join their team, in hopes of developing the current high performing team. They are located in the West.

Job Responsibilities

• Responsible for the designing and evaluating processes, mechanisms, and equipment used in inspection and testing.
• Responsible for root cause analyses of incidents that necessitate corrective actions.
• Responsible for quality assurance tests and statistical analyses to assess control levels and manage risks related to product quality
• Ensuring that corrective measures and deviations meet with the standards
• Responsible for the creating and executing methods and procedures for whole process of production equipment (e.g. the inspection, testing, and evaluation of the products).

Requirements

• Min Diploma/Degree in engineering or equivalent
• Min 3 years’ relevant working experience in Quality Management
• Certified in API Q1, Q2, ISO and other relevant auditor would be advantages.

Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/cv.

We regret that only shortlisted candidate will be notified.

Recruitpedia Pte. Ltd.

EA License No. 19C9682

EA Reg. No. R23115553 (Lai Hor Yan)

[12 months contract, renewable]

We're seeking an experienced Automation QA Engineer to design, develop, and maintain automated test frameworks and scripts for our software products. The ideal candidate will work closely with developers and product managers to ensure high-quality software delivery.

Key Responsibilities:

• Develop and execute automated test scripts using industry-standard tools

• Design and implement test automation frameworks

• Collaborate with cross-functional teams to identify test requirements

• Analyse test results and report defects

• Continuously improve automation processes and methodologies

Requirements:

• Bachelor's degree in Computer Science or related field

• 3+ years of experience in software QA automation

• Proficiency in scripting languages (e.g., Python, JavaScript)

• Experience with test automation tools (Selenium)

• Strong understanding of software development lifecycle

• Excellent problem-solving and analytical skills

Preferred Skills:

• Knowledge of CI/CD pipelines

• Experience with API testing and performance testing

• Familiarity with Agile methodologies

• Familiarity with OutSystems environment and setup

Responsibilities

Quality Assurance:

• Overall implementation and maintenance of the Quality Management System (QMS) in compliance with ISO 13485 and 21 CFR 820 standards.
• Ensure all departments carry out due processes and documentation required to ensure conformance to the QMS, including design & development, production and software.
• Conduct internal audits and lead external audit preparations.
• Conduct Management Review, onboarding training for new employees, and company-wide refresher training
• Collaborate with cross-functional teams to address non-conformances, CAPAs, and continuous improvement initiatives.
• Participate in risk analysis and management activities to ensure compliance with ISO 14971.
• Support post-market surveillance and vigilance reporting activities.

Regulatory Affairs:

• Preparation, submission, and maintenance of regulatory documentation for market approvals in regions including Singapore, US, Malaysia, and Australia.
• Monitor and interpret regulatory updates and standards relevant to medical devices.
• Ensure labeling, packaging, and promotional materials comply with regulatory requirements.
• Collaborate with the R&D and manufacturing teams to ensure product compliance during development and production phases.
• Maintain accurate and organized records to support regulatory inspections and audits.

Minimum Skills and Requirements

• Bachelor’s degree in Engineering, Science, or a related field.
• Ability to work independently and cross-functionally with different teams
• Strong organizational and analytical skills.
• Effective communication and teamwork abilities.

Advantageous Skills

• Knowledge or experience with regulatory submissions to Malaysia MDA, Australia TGA, US FDA, and Singapore HSA.
• Familiarity with ISO 13485, ISO 14971, and other relevant standards.

Responsibilities:

• Validation quality review of lifecyle documents and protocols for Automation CSV qualification, EFU qualification, cleaning validation, laboratory equipment qualification, and IT systems qualification.
• Review and approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines timely
• Review and approve as needed, qualification/validation executed package validation exceptions, deviation, and investigations encountered during qualification/validation representing Quality
• Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification/validation activities
• Participate in site Validation Maintenance Program
• Any other tasks as and when assigned by supervisor
• Support other technical changes and duties as require

About You:

• Diploma/Bachelor/Master/Doctoral Degree in Engineering/Science
• At least 5 years qualification/validation experience
• Possess process automation experience will be the additional benefit to be considered
• Communicate well, self driven, motivated and able to work well with others
• Based in Tuas

Job Type: Contract

Contract length: 9 months

Salary: up to $6000

Duration: 6 months contract

Working Days & Hours: Monday - Friday Office Hours

Location: Tuas (bus provided to and fro Tuas Crescent MRT)

Job Description:

• Support day-to-day Quality Assurance activities in accordance with approved

SOPs / Policies for a multi-product, cGxP contract manufacturing facility

• A good understanding of cGxPs and compliance in a GxP manufacturing

setting performing both supervised and unsupervised tasks

• Receive minimal supervision and able to perform independently on routine

assignments

• Revise, review and approve SOPs, protocols, reports or records

• Make real-time decisions on process events on the floor based on knowledge

of defined SOPs & policies

• Demonstrate appropriate interpersonal skills which encourage collaboration

of individuals or teams to meet objectives

• Any other tasks as and when assigned by supervisor

Job Requirements: Min Degree in Life Sciences & min 3 years of relevant QA experience in Pharmaceutical industry

Interested candidates, please submit your resume to: [email protected]

Ally Audrey Lok Xin Woon

Recruit Express Pte Ltd (Healthcare & Lifescience)

Company EA Licence number : 99C4599

Personnel EA License: R21102307

[email protected]

• Devising and implementing methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment
• Designing and analysing inspection and testing processes, mechanisms, and equipment
• Conducting quality assurance tests and performing statistical analysis to assess the level of control and manage product quality risks
• Undertaking root cause analysis of incidents requiring corrective action
• Ensure that corrective measures and deviation meet acceptable reliability standards
• Other ad hoc duties assigned

Requirements

• API Q1 and Q2 certifications
• Internal audit certification

Interested applicants may email resume to [email protected]

Jessie Hoe Huey Miin (CEI Registration No: R1103861)

Recruit Express Pte Ltd (EA: 99C4599)

• Devising and implementing methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment
• Designing and analysing inspection and testing processes, mechanisms, and equipment
• Conducting quality assurance tests and performing statistical analysis to assess the level of control and manage product quality risks
• Undertaking root cause analysis of incidents requiring corrective action
• Ensure that corrective measures and deviation meet acceptable reliability standards
• Other ad hoc duties assigned

Requirements

• API Q1 and Q2 certifications
• Internal audit certification

Joy Yeow Zhi Qian

(CEI Registration No:R2096261)

Recruit Express Pte Ltd (EA Licence No: 99C4599)

• Devising and implementing methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment
• Designing and analysing inspection and testing processes, mechanisms, and equipment
• Conducting quality assurance tests and performing statistical analysis to assess the level of control and manage product quality risks
• Undertaking root cause analysis of incidents requiring corrective action
• Ensure that corrective measures and deviation meet acceptable reliability standards
• Other ad hoc duties assigned

Requirements

• API Q1 and Q2 certifications
• Internal audit certification

Joy Yeow Zhi Qian

(CEI Registration No:R2096261)

Recruit Express Pte Ltd (EA Licence No: 99C4599)

• Well Established Company
• Basic $3000 - $3500 + AWS + Variable Bonus
• Excellent Welfare and Benefits + Career progression
• Working location: Boon Lay
• Working day: Monday to Friday
• Working hours: 8.30am to 6.30pm

Job Responsibilities:

• Lead and supervise a team of QC inspectors overseeing daily QC inspections activities in compliance with established standards
• Provide training, coaching and mentoring to enhance the skills and performance of team members
• Prepare and maintain work schedule for the department to ensure optimize resource for overall efficiency
• Work with cross-functional teams to implement continuous improvement, track status of non-conformities and CAPA effectiveness
• Responsible for review and approval of DHR. Ensure quality records and samples are retained complying with good writing practice GDP requirements
• Implement quality documentation changes, such as QC procedures, process workflows, work instructions, etc. Guide the team to follow through the change
• Review and submit validation or verification measurement reports
• Perform daily process audit to meet quality operational requirements
• Assist in customer complaint analysis, investigation of quality issues and corresponding improvement measures
• Authorize the release (COC) of products, COA review and approval
• Monitor and report KPI of QC team job performance, production quality trends, quality control charts, etc.

Job Requirements:

• Possess minimum professional certification / Diploma / Degree in relevant subject area
• Working knowledge on ISO13485:2016 and quality assurance / quality control of medical devices is an added advantage
• Familiar with use of various quality control tools and test equipment

Candidates are encouraged to apply this position via Apply Now button with the following information in the resume

• Work experiences and job responsibilities
• Current and Expected salary
• Reason for leaving
• Date of availability
• Education background

We regret that only shortlisted candidates will be contacted.

LIONG ZHAO GUAN (R22107632)

EA Recruitment Pte Ltd

EA License No: 21C0492

The Opportunity

• Opportunity to work with MNC Client
• 5 days' work week, Office Hours
• Working location: CBD

Key Responsibilities:

1. EN 9100 Certification Preparation:
   • Lead the deployment and implementation of EN 9100 standards within the new factory.
   • Develop and oversee the creation of required process documents, including Quality Manuals, flowcharts, procedures, and work instructions.
2. Process Optimization and Documentation:
   • Conduct process mapping to define and document process flows, interfaces, inputs/outputs, criteria, and KPIs.
   • Establish and maintain dashboards to monitor quality performance and ensure compliance with EN 9100 standards.
3. Auditing and Compliance:
   • Conduct internal and external audits in line with certification requirements (e.g., EN 9100, ISO 9001, ISO 14001, etc.).
   • Support and coordinate Management System Certification audits, ensuring successful outcomes.
4. Team Engagement and Communication:
   • Act as the primary point of contact for all quality-related activities, engaging with cross-functional teams to align actions with certification goals.
   • Drive team collaboration through effective communication, synthesizing information, pushing action plans, and ensuring feedback loops.
5. Continuous Improvement:
   • Identify gaps and areas for improvement within existing processes and implement corrective actions.

Required Qualifications and Skills:

Education and Experience:

• Bachelor’s degree in Engineering, Quality Management, or a related field.
• Minimum of 3 years of experience in EN 9100or ISO 9001 standard deployment or operations.

Technical Skills:

• In-depth knowledge of EN 9100 standards (ISO 9001 knowledge is acceptable if complemented by relevant experience).
• Proven expertise in internal and external audits, with experience in certifications such as ISO 9001, EN 9100, ISO 14001, or ISO 17025.
• Strong process-oriented mindset with the ability to map processes, define KPIs, and develop dashboards.
• Proficient in creating and revising quality documentation, including manuals, flowcharts, and procedural instructions.

Next Step

Prepare your updated resume and expected package.

Simply click on 'Apply here' or email to [email protected] to drop your resume

All shortlisted candidates will be contacted.

Prasant Sirohi

EA Licence Number: 91C2918

Registration Number: R22106307

9 months contract

Salary: $4000-$5000

Location: Tuas (pickup islandwide)

Working hours: Mon-Fri, 9-5pm

Responsibilities:

• Lead the Supplier Quality team in the manager's or supervisor's absence.
• Ensure compliance with policies and oversee Supplier Quality programs.
• Monitor and verify that incoming materials meet company standards and policies.
• Manage material nonconformity investigations with cross-functional teams.
• Serve as the primary contact for supplier qualifications, audits, and related documentation.
• Prepare, maintain, and review GMP documentation, including Quality Technical Agreements.
• Coordinate supplier quality issues, audits, and follow-up actions.
• Support global supplier quality initiatives and site improvement projects.
• Oversee incoming material inspections, raw material checks, and release processes.
• Analyze performance metrics for Supplier Quality Management and CAPA systems.
• Provide QA oversight for materials reduced testing programs and generate quality metrics reports.
• Lead and coordinate cross-functional teams and projects as needed.
• Support regulatory inspections without disrupting daily operations.
• Assist in guiding and developing team members, ensuring training and competency.
• Promote workplace safety and maintain high customer satisfaction by managing relationships effectively.
• Perform other tasks as assigned by the Supplier Quality Supervisor.

Requirements:

• Min. Diploma
• Preferably someone with knowledge of GMP, CAPA

Interested candidates, do submit your resume to [email protected] or telegram @alexgohhl

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Alex Goh Hock Leong

(CEI.No: R1763413 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599)

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