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

Job summary:
Experience in marine and oll & gas sector.
Responsible for the assigned customer account, to ensure all product quality, process quality andsystem quality to conform with customers' specifications and internal quality system reauirements

Roles & Responsibilities:
1.To liaise with Customer Quality representatives on all Quality matters.
2.Lead the investigation on all Customer Quality Feedback, Complaints and CAR with internal cross.functional team for comprehensive root cause failure analysis and ensure closure with effectiveimplementation of corrective actions and preventive actions.
3. Monitor product quality performance and generate quality reports; chair monthly product qualityimprovement meetings to reduce the customer reject and field return rate for continual improvement!Identify Quality lmprovement projects and initiatives to drive Customer Satisfaction with Quality.
4.Establish with customer representative and internal team on New Product Quality plans, procedureswork instruction for overall auality control and coordinate implementatilon and maintenance of suchplans, procedures or instructions; conduct quality training/ cross training for QA inspectors.
5.Audit customer fabrication line for compliance to applicable standards and procedures in QMs andEMS

58 RECRUITMENT PTE. LTD. 19C9772 67026282

Need to know Zeiss CMM Program

Need to Know Zeiss CMM Operation

Have Quality Assuarnce & Quality Control Knowledge

Know incoming / In-process / External provider parts insepection

Know prepare of quality documentation and maintenance documents like daliy Monitoring Data and Monthly Data performance

Will preapare of documentation for customer audit and ISO audit

Job Description

• Industry/ Organization Type: Education
• Position Title: Quality Assurance Executive
• Working Location: Seletar
• Working Hours: 5 Days, Mon – Fri (9am – 6pm)
• Salary Package: Basic Salary (Up to $5,000) + AWS
• Duration: Permanent

Key Responsibilities

• Support the Manager in performing audits to ensure adherence to standards, including those under the Private Education Act, Private Education Regulations, EduTrust Certification Scheme, and Enhanced Registration Framework.
• Evaluate audit data to pinpoint performance discrepancies, observe trends, and assess process efficiency for ongoing enhancement.
• Work alongside departments to grasp relevant frameworks, organizational policies, and procedures, and suggest modifications.
• Discover opportunities for refining audit and/ or assessment processes.
• Other tasks as necessary.

APPLY NOW!!!

• Proficient in audit management, data analysis, quality assurance, and internal controls.
• Experience in Quality Assurance within a Private Education Institution (PEI) is an added advantage
• Familiarity with the Private Education Act, Enhanced Registration Framework, EduTrust Certification Scheme, and related standards is preferred.
• Excellent problem-solving, communication, and interpersonal abilities.

Kindly apply through ANY of the following methods:

• Submit your application by clicking the APPLY button;
• Email your resume to [email protected]. Please indicate #71571 on the email subject.

Anradus Application Policy: We value each application and ensure every resume is reviewed. Our process is efficient, typically concluding within 3 working days. If you do not receive communication from us within this timeframe, it's likely that your application has not been shortlisted by our client. In such cases, we recommend continuing your job search to maximize your opportunities.

Anradus Pte Ltd | EA License No. 20C0161 | Adelin Chong | EA Reg No.: R1875641

Job Description

• Industry/ Organization Type: Education
• Position Title: Quality Assurance Executive
• Working Location: Seletar
• Working Hours: 5 Days, Mon – Fri (9am – 6pm)
• Salary Package: Basic Salary (Up to $5,000) + AWS
• Duration: Permanent

Key Responsibilities

• Support the Manager in performing audits to ensure adherence to standards, including those under the Private Education Act, Private Education Regulations, EduTrust Certification Scheme, and Enhanced Registration Framework.
• Evaluate audit data to pinpoint performance discrepancies, observe trends, and assess process efficiency for ongoing enhancement.
• Work alongside departments to grasp relevant frameworks, organizational policies, and procedures, and suggest modifications.
• Discover opportunities for refining audit and/ or assessment processes.
• Other tasks as necessary.

APPLY NOW!!!

• Proficient in audit management, data analysis, quality assurance, and internal controls.
• Experience in Quality Assurance within a Private Education Institution (PEI) is an added advantage
• Familiarity with the Private Education Act, Enhanced Registration Framework, EduTrust Certification Scheme, and related standards is preferred.
• Excellent problem-solving, communication, and interpersonal abilities.

Kindly apply through ANY of the following methods:

• Submit your application by clicking the APPLY button;
• Email your resume to [email protected]. Please indicate #71571 on the email subject.

Anradus Application Policy: We value each application and ensure every resume is reviewed. Our process is efficient, typically concluding within 3 working days. If you do not receive communication from us within this timeframe, it's likely that your application has not been shortlisted by our client. In such cases, we recommend continuing your job search to maximize your opportunities.

Anradus Pte Ltd | EA License No. 20C0161 | Adelin Chong | EA Reg No.: R1875641

Job Description

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

Requirement

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

JOBSCOPE OVERVIEW

1. Represent QA/QC department in 2G Management Meetings or other meetings required by Directors.

2. Create and maintain standard operating procedure (SOP’s), protocols, guidelines that ensure consistency and efficiency throughout the QA cycle.

3. Acts as Committee of all ISO audits.

4. Supervise and manage QA/QC team and interns.

5. Conduct physico-chemical and microbiological test for Chemicals and Incoming Paper.

6. Liaise with suppliers and third-party agencies.

7. Provide technical support to the sales and marketing team regarding product specifications, sample requirement & others.

8. Document those methods in standard operating procedures (SOPs) and production records, quality assurance activities with internal reporting and audits.

9. Review and compile documents for Audits (Batch Record: Prod sheet, Quality control test Reports; FG and RM Reports, Mixing records).

10. Ensure that on time calibration program of equipment (mechanical and lab instruments, weighing scales and test weights) are executed.

11. Assist to do in compounding and mixing when Mixer Operator is on leave.

12. Liaise with Overseas factory (China and Indonesia) to ensure that product or service meets specified requirements.

13. Review method validation study reports, ensure proper documentation of findings, and assist in approval or re-validation recommendations. Prepare summary reports of validation activities, results, and recommendations for management review.

14. Investigate validation failures or deviations, identify CAPA, and ensure implementation. Collaborate with cross-functional teams to enhance the efficiency and effectiveness of validation activities.

15. Identify risks in testing methods, implement mitigation strategies, and ensure data integrity during validation to maintain accuracy, reproducibility, and regulatory compliance.

16. Review and approve method validation documentation, ensuring accuracy, completeness, and compliance with quality standards. Maintain up-to-date records of validation activities, deviations, CAPA, and ensure proper version control for all related documents.

17. Provide training on method validation processes and best practices, and support Production, QC and R&D teams in executing protocols and analyzing data accurately.

18. Any other area of responsibilities that the company deems necessary.

A. QUALITY CONTROL

1. Manage product complaints or non-conformances; thoroughly investigate process failure, determine the root cause, and take prompt corrective actions.

2. Conduct physical, physico-chemical test and microbial analysis of finished product.

3. Track the materials (chemicals and fragrance) that are present in the chemical room and know whether additional supplies need to be ordered.

4. Calibrate all equipment for In-house verification Example – pH meter, weighing scale etc. and arrange external calibration with external party.

5. Train new production operators in quality control.

6. Any other area of responsibilities that the company deems necessary.

B. LIAISE WITH SUPPLIERS (Services):

1. DI Water System Maintenance (Requirements: According to Contract): Loop Sterilization, UV-Lamp etc.

2. Complete Water Quality Testing (annual) by External Lab

3. Monitor the consumable supplies from different suppliers for DI Water (Column, filters, gauges).

4. Wet Wipes Monthly External Microbial testing

5. Monitor the annual cleanroom Certification.

6. External Calibration of Equipment

7. Any other area of responsibilities that the company deems necessary.

C. PRODUCT TECHNICAL SUPPORT

1. Support Export Sales and Marketing for preparation of documentation for regulatory use (COA, Ingredient’s list, FG and RM spec etc).

2. Collaborate with development, QC, and regulatory teams to plan, execute, and review method validation protocols, ensuring compliance with applicable guidelines (e.g., ICH, FDA, EMA) and company procedures, while meeting regulatory standards for intended use.

3. Support on the process validation on the manufacturing of the product.

4. Any other area of responsibilities that the company deems necessary.

Our client is one of the leading medical manufacturers. Due to business needs, they are now recruiting a Quality Assurance Engineer to be part of their QA Team for ongoing transformation projects. They are located in the East - easily accessible.

Duties of Quality Assurance Engineer:

• Maintain and update Quality Management System (QMS) procedures to ensure compliance.
• Verify process documentation, including work instructions, quality inspection plans, data sheets, and inspection reports.
• Lead and guide quality control inspectors to uphold compliance standards.
• Oversee in-process and final quality inspections, collaborating with internal teams to address manufacturing quality issues.
• Resolve process non-conformance issues promptly and effectively.
• Address customer complaints through containment actions, root cause analysis, and implementation of corrective and preventive measures.
• Manage documentation control systems and facilitate internal and external audits.
• Ensure timely completion of customer environmental surveys and related requests.
• Provide support for QA/QC activities, projects, and other ad hoc duties as needed.

Requirements:

• Diploma in related field
• Relevant experience in Medical Manufacturing Industry

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.

• Email Address: [email protected]
• EA License No: 19C9682
• EA Personnel No: R2199158
• EA Personnel Name: Soo Wei De

About Us

Vivo Surgical is a patient-focused, clinician-driven medical device developer and manufacturer. Headquartered in Singapore with offices in China and Thailand, we are pioneering a novel endoscopic surgical robot for complex endoluminal surgeries. ISO 13485 certified with international accreditations awarded such as the US FDA and European CE mark, our devices target the medical needs of the world through innovative applications of science & technology. These encompass such fields as in vivo surgical LED lighting, portable endoscopy and endoscopic robots, which are strategically co-developed with world-class healthcare institutions and KOL collaborators. Join us as we build towards our vision of being Asia Pacific’s leading medical device developer and manufacturer.

About The Role

We value the importance of having a robust Quality Assurance and Regulatory Affairs team that would serve as a key pillar for sustained commercial success. To that end, we are looking for a Quality Assurance & Regulatory Affairs Manager to join us on this journey. You will be part of our fast-growing team and will take ownership of your role from the get-go. You will work on ensuring our company’s commitment to comply with regulatory requirements and to maintain the effectiveness of our Quality Management System (QMS). You will also be in charge of our products’ regulatory strategies and submissions to various regulatory bodies. Your role will enable you to work not only with diverse functions internally but also in close tandem with our external partners such as our suppliers, distributors and notified bodies.

Your responsibilities shall include the following:

• Ensure the company’s QMS complies with ISO 13485 and FDA 21 CFR 820/QMSR.
• Develop and manage Quality Procedures such as document control, CAPA, NCR, Supplier Control, Production Control, Feedback and Complaints Handling, and Post Market Surveillance.
• Organize and execute internal audits, management reviews and supplier audits.
• Plan and lead ISO 13485 audits and regulatory inspections.
• Participate in the products’ verification and validation activities.
• Develop, review and compile the medical device technical files whilst making sure the products meet all regulatory and quality standards.
• Involved in risk assessment tasks to identify potential quality and compliance risks in the product lifecycle and advise adequate risk control measures.
• Serve as the company’s Quality Management Representative (QMR) and Person Responsible for Regulatory Compliance (PRRC).
• Manage and mentor the QARA team to ensure members are adequately trained.
• Stay updated on medical device laws and regulations in the targeted markets.
• Work with senior management to define and deliver adequate quality and regulatory strategies.

Your Qualifications & Experience

• Minimum Bachelor’s degree in Engineering or Science.
• At least 5 years’ experience in quality assurance and/or regulatory affairs in the medical device Industry.
• Firm understanding of ISO 13485:2016, FDA 21 CFR 820/QMSR and ISO 14971.
• Prior involvement in HSA, FDA 510(k)/De Novo and/or MDR 2017/745 submissions will be a plus.
• Experience in generating risk management documentation (risk management plan, report, FMEAs).
• Possess a leadership and strategic mindset to organize and prioritize tasks for effective and timely delivery of regulatory goals to meet the company’s business objectives.
• Certification as an ISO13485:2016 lead auditor will be advantageous.

Contact

Please send your CV and cover letter to: [email protected]. We look forward to receiving your application.

Our client is one of the leading medical manufacturers. Due to business needs, they are now recruiting a Quality Assurance Engineer to be part of their QA Team for ongoing transformation projects. They are located in the East - easily accessible.

Duties of Quality Assurance Engineer:

• Maintain and update Quality Management System (QMS) procedures to ensure compliance.
• Verify process documentation, including work instructions, quality inspection plans, data sheets, and inspection reports.
• Lead and guide quality control inspectors to uphold compliance standards.
• Oversee in-process and final quality inspections, collaborating with internal teams to address manufacturing quality issues.
• Resolve process non-conformance issues promptly and effectively.
• Address customer complaints through containment actions, root cause analysis, and implementation of corrective and preventive measures.
• Manage documentation control systems and facilitate internal and external audits.
• Ensure timely completion of customer environmental surveys and related requests.
• Provide support for QA/QC activities, projects, and other ad hoc duties as needed.

Requirements:

• Diploma in related field
• Relevant experience in Medical Manufacturing Industry

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.

• Email Address: [email protected]
• EA License No: 19C9682
• EA Personnel No: R2199158
• EA Personnel Name: Soo Wei De

Our client is one of the leading medical manufacturers. Due to business needs, they are now recruiting a Quality Assurance Engineer to be part of their QA Team for ongoing transformation projects. They are located in the East - easily accessible.

Duties of Quality Assurance Engineer:

• Maintain and update Quality Management System (QMS) procedures to ensure compliance.
• Verify process documentation, including work instructions, quality inspection plans, data sheets, and inspection reports.
• Lead and guide quality control inspectors to uphold compliance standards.
• Oversee in-process and final quality inspections, collaborating with internal teams to address manufacturing quality issues.
• Resolve process non-conformance issues promptly and effectively.
• Address customer complaints through containment actions, root cause analysis, and implementation of corrective and preventive measures.
• Manage documentation control systems and facilitate internal and external audits.
• Ensure timely completion of customer environmental surveys and related requests.
• Provide support for QA/QC activities, projects, and other ad hoc duties as needed.

Requirements:

• Diploma in related field
• Relevant experience in Medical Manufacturing Industry

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.

• Email Address: [email protected]
• EA License No: 19C9682
• EA Personnel No: R2199158
• EA Personnel Name: Soo Wei De

Roles & Responsibilities

Job Responsibilities

· Lead and drive the team for continuous improvement on system and process, conduct monthly QPR meeting and review typical quality issues and follow up with team for improvement.

· Work as quality representative of tool room to manage customer audit, ISO audit and internal audit, prepare the team for the audit and subsequent activities.

· Monitor KPI of tool room and attend annual MR meeting to report tool room KPI performance.

· Lead QA/metrology team for inspection activities and work closely with engineering team for tool improvement.

· Study critical characteristic of new product drawing requirement, propose steel safe strategy with past similar tool experience into tooling design.

· Manage customer complaint and attend customer meeting related to quality or metrology issues.

· Monitor supplier quality performance and issue corrective and preventive action report to drive continuous improvements.

· Perform audits on supplier’s process to ensure quality control and quality assurance systems are in place

· Publish tool fabrication quality standards and ensure suppliers understood and comply with the requirements

· Assist in evaluation and qualification of new supplier.

· Other duties as and when assigned by Supervisor or Management

You may be authorized to:

· Contain suspected, non-conforming products and prevent from further processing.

· Stop new orders which do not conform to requirements.

Requirements

· Degree or Diploma in Quality Engineering or relevant

· Minimum 5 years of relevant experience in a plastic injection molding industry

· Knowledge and experience in GD&T, SQC tool

· Certified Internal Auditor for ISO 9001, ISO14001 and ISO 13485.

· Ability to apply problem solving technique and provide solutions under minimal supervision.

· Good written and oral communication skills

· Organized, decisive, logical, Independent and possess leadership, organization and communication skills

We are looking for a proactive Quality Assurance Tester to enhance their testing capabilities and collaborate within an Agile framework with a mandatory experience in Temenos 24.

Responsibilities:

• Review and analyze user stories to refine them from a testing perspective.
• Collaborate with squads to develop test strategies and plans.
• Execute test cases, document results, and report defects in an audit-compliant manner.
• Support squads in troubleshooting and resolving defects.
• Assist test engineers in developing test automation solutions.
• Provide continuous feedback by reporting defects and issues in a timely manner.
• Ensure quality throughout the change process in collaboration with squads.
• Improve testing services as part of an ongoing improvement process.
• Conduct post-release testing, production support, and training for support teams.

Requirements:

• Proven experience as a Quality Assurance Tester, preferably in the financial industry.
• Hands-on experience with Agile frameworks and QA methodologies.
• Experience testing both in-house developed and vendor-based applications.
• Strong understanding of functional and workflow-based system design, especially across interconnected systems.
• Solid knowledge of securities lending, repo, and back-office processes:
• Settlement workflows (DVP, FOP)
• Corporate actions and securities positions
• Trading, collateral management, and financial workflows.
• Experience with Temenos T24.
• Proficiency in Jira and testing tools.
• Strong communication skills in English.

This is an initial 1-year contract role. (Perm conversion)

We are looking for a proactive Quality Assurance Tester to enhance their testing capabilities and collaborate within an Agile framework with a mandatory experience in Temenos 24.

Responsibilities:

• Review and analyze user stories to refine them from a testing perspective.
• Collaborate with squads to develop test strategies and plans.
• Execute test cases, document results, and report defects in an audit-compliant manner.
• Support squads in troubleshooting and resolving defects.
• Assist test engineers in developing test automation solutions.
• Provide continuous feedback by reporting defects and issues in a timely manner.
• Ensure quality throughout the change process in collaboration with squads.
• Improve testing services as part of an ongoing improvement process.
• Conduct post-release testing, production support, and training for support teams.

Requirements:

• Proven experience as a Quality Assurance Tester, preferably in the financial industry.
• Hands-on experience with Agile frameworks and QA methodologies.
• Experience testing both in-house developed and vendor-based applications.
• Strong understanding of functional and workflow-based system design, especially across interconnected systems.
• Solid knowledge of securities lending, repo, and back-office processes:
• Settlement workflows (DVP, FOP)
• Corporate actions and securities positions
• Trading, collateral management, and financial workflows.
• Experience with Temenos T24.
• Proficiency in Jira and testing tools.
• Strong communication skills in English.

This is an initial 1-year contract role. (Perm conversion)

We are looking for a proactive Quality Assurance Tester to enhance their testing capabilities and collaborate within an Agile framework with a mandatory experience in Temenos 24.

Responsibilities:

• Review and analyze user stories to refine them from a testing perspective.
• Collaborate with squads to develop test strategies and plans.
• Execute test cases, document results, and report defects in an audit-compliant manner.
• Support squads in troubleshooting and resolving defects.
• Assist test engineers in developing test automation solutions.
• Provide continuous feedback by reporting defects and issues in a timely manner.
• Ensure quality throughout the change process in collaboration with squads.
• Improve testing services as part of an ongoing improvement process.
• Conduct post-release testing, production support, and training for support teams.

Requirements:

• Proven experience as a Quality Assurance Tester, preferably in the financial industry.
• Hands-on experience with Agile frameworks and QA methodologies.
• Experience testing both in-house developed and vendor-based applications.
• Strong understanding of functional and workflow-based system design, especially across interconnected systems.
• Solid knowledge of securities lending, repo, and back-office processes:
• Settlement workflows (DVP, FOP)
• Corporate actions and securities positions
• Trading, collateral management, and financial workflows.
• Experience with Temenos T24.
• Proficiency in Jira and testing tools.
• Strong communication skills in English.

This is an initial 1-year contract role. (Perm conversion)

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

The Career Conversion Programme (CCP) (Train-and-Place with Commitment to Hire) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals is a talent development programme aimed at building the next generation of skilled manpower for Singapore’s Biopharmaceuticals manufacturing industry in anticipation of hiring demand.

The training programme consists of 15 months of local attachment with GSK. Due to the nature of the programme, we can only consider Singapore Citizens and Singapore Permanent Residents. For more information, please visit Career Conversion Programmes (CCP) for Individuals

Purpose:

• To be responsible for managing the interactions with third party organisations that supply QA incoming materials and/or services to GSK.
• To manage material release for incoming materials, supplier change notifications and new material management.
• To provide Quality oversight to logistics management and warehouse operations.

Key Responsibilities:

Supplier Management

• Provide QA oversight of Supplier management activities on site to achieve compliance with company policies and government regulations as assigned.
• To participate (Executive 1) and to represent the site (Executive 2) for Supplier Management business processes to drive improvements and share best practises across the GSK Vaccines network.
• Process owner/support supplier complaint process for QA incoming materials. Lodge supplier complaints and ensure suppliers identify the root cause and associated CAPA's to prevent recurrence of supplier quality issues.
• Review and track supplier-related CAPA for timely closure.
• Maintain inspection readiness, conduct supplier assessments for both new and current service providers in a timely manner.
• Maintain the approved supplier listing and audit schedule in a state of compliance and accuracy.
• Assess supplier change notifications in a timely manner and escalate where necessary especially in situations with supply impact.
• Initiate and review deviations/change control/CAPA associated with incoming material.

Executive 1: Minor deviations and CAPA

Executive 2: Minor, major deviations and CAPA

• Work closely with site user and Global stakeholders for Supplier management related matters

QA Raw Material Release and Warehouse oversight

• Support incoming material documentation review and release to recommend and confirm Usage Decision (UD) of raw material
• Ensure that material document file (MDF) is complete and accurate before disposition of material in SAP
• Ensure that system is in place for filing and archival of MDF
• Initiate and review deviations/change control/CAPA associated with incoming material releases.
• Ensure that all deviations/change controls are closed or assessed for impact on the release of the material prior to release the QA-controlled incoming material
• Provide QA oversight to warehouse such as attending warehouse tier, conduction GEMBAs, inspection readiness and warehouse related deviations, CAPAs and change control

Decision Making:

Proposals & Recommendations

• Propose improvements to work processes, with basic awareness of business requirements.
• Deviation investigations and assessments
• In addition for QA Executive 2:
• Able to provide QA oversight on routine situations independently and complex situations with supervision (deviations, changes, system issues, compliance matters)
• Able to manage simple department projects (e.g. continuous improvement) with supervision
• Greater awareness of business requirements and to highlight considerations where there is a need for escalation

Skills:

Professional

• At least University basic degree in a Science or Engineering discipline

Technical

• A good understanding of cGMP regulatory and legal requirements as applied to quality assurance of pharmaceuticals manufacturing
• User experiance with SAP will be prefered
• Ability in handling and organizing multiple workflows

Business

• Ability to apply optimal quality assurance standards to promote a business edge
• Ability to facilitate business activities commpatible to international regulatory environment
• Ability to communicate effectively within the site organization and across the network

Competencies:

• Working knowledge of FDA/EU/ICH/WHO as well as all other relevant reuglatory and technical guidelines
• Possess Analytical and Quality performance mindset
• Demonstrate professional & ethical integrity
• Fluency in the English language
• Demonstrates sense of urgency
• Ability to work both as an individual contributor and as a team player.

Where will I be based?

You will be based at one of our manufacturing site in Singapore near Tuas.

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.

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

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

Key Points:

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

Responsibilities:

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

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

Requirements:

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

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

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

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

We are hiring Contract Quality Assurance to be outsourced to our clients from reputable healthcare organizations.

Apply now!

Job Scope

• Support Validation Projects: Assist with qualification and validation activities, ensuring compliance with company procedures and regulations.
• Review and Approve Documents: Review and approve validation documents like protocols, reports, and procedures.
• Manage Discrepancies: Identify and address issues in validation protocols, ensuring corrective actions are documented.
• Act as Quality Representative: Participate in cross-functional projects as the Quality Systems and Validation representative.
• Provide Validation Expertise: Offer guidance on creating or updating validation documents, such as for analytical instruments and methods.
• Ensure Document Readiness: Ensure all qualification/validation documents are clear and inspection-ready.
• Support Ongoing Validation: Oversee the Master Validation Plan and support routine qualification activities.
• Collaborate Across Sites: Help standardize validation processes across multiple sites.
• Train and Coach: Develop training materials and provide support to team members and other departments.

Job Requirements

• Bachelor’s degree in Pharmaceutical Sciences, Life Sciences, Biology, Biotechnology, Chemistry, Chemical Engineering, Engineering, or related field.
• At least 2-3 years of experience in quality assurance, manufacturing operations, or validation in the pharmaceutical or biotechnology industry. Experience in equipment, process, cleaning, and computer systems validation is preferred.
• Strong understanding of FDA/EU cGMP requirements, including CFR 21 Part 11, and familiarity with PDA and ISPE GAMP guidelines.

All Interested candidates are invited to email your resume in MS Word format to:

[email protected]

Please include your full working experience, education background, notice period, expected salary.

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

We regret to inform that only suitable candidates will be shortlisted for an interview.

We are seeking a highly skilled and experienced Software Quality Assurance (QA) Lead to oversee the testing and quality assurance efforts for our web application projects. The ideal candidate will ensure the delivery of high-quality software by implementing robust testing strategies, managing a team of QA engineers, and collaborating with cross-functional teams to meet project goals and timelines.

Role & Responsibilities:

• Develop and implement QA strategies, test plans, and scripts for web and mobile applications.
• Lead and mentor a QA team, fostering collaboration with development and other stakeholders.
• Oversee all phases of testing, including functional, regression, performance, and security testing.
• Manage manual and automated testing efforts across multiple platforms (PC/Android/iOS).
• Identify and resolve software defects, collaborating with development teams to improve processes.
• Drive the adoption of automation testing frameworks and tools, optimizing test environments.
• Ensure compliance with security, accessibility, and regulatory standards.
• Promote a quality-focused culture throughout the development lifecycle.

Ideal candidate:

• 5+ years in software quality assurance, including 2+ years in a lead role.
• Strong understanding of web application architecture, testing methodologies, and SDLC.
• Experience with QA tools (e.g., Selenium, JIRA, Postman) and automation tools (e.g., Katalon, pCloudy).
• Familiarity with CI/CD pipelines, Agile/Scrum, and DevOps practices.
• Knowledge of performance testing tools (e.g., JMeter, LoadRunner) and scripting languages (e.g., Python, JavaScript).
• Hands-on experience with mobile and Svelte-based app testing frameworks.
• Strong leadership, problem-solving, and communication skills.
• Familiarity with Linux, Windows, Amazon Cloud, and EKS.

Mon to Fri 8.30am - 5.30pm

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

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

COMPANY DESCRIPTION

Beyondsoft International (Singapore) Pte. Ltd. was set up in 2007 and established as the regional headquarters for the Southeast Asia (SEA) and European markets in September 2015. Based on our vision of "Using technology to promote social progress, economic development and become a global customer preferred partner" and our concept of "Beyond your expectations", Beyondsoft is committed to provide our customers in countries along the "Belt and Road" with comprehensive solutions and products and creating commercial value for customers to realizing continuous businesses development.

Our core business includes:

1. IT development services providing customers with IT consulting, software research and development, software and hardware testing, system integration and operation and maintenance, data analysis and other services;
2. New retail solutions and products through intelligent products, helping small and medium-sized enterprises (SMEs) realize the digital transformation of their daily operations;
3. Internet of Things (IoT) platform and solutions comprehensive use of IoT, artificial intelligence, big data, cloud computing and other technologies to provide IoT solutions for intelligent upgrades in cities, parks, buildings and industries, to create a smart future.

RESPONSIBILITIES

• Define and implement QA strategies, test plans, and test cases for web applications.
• Lead and mentor a team of QA engineers, fostering collaboration with cross-functional teams.
• Oversee all testing phases, including functional, integration, regression, performance, and security.
• Implement automation frameworks and optimize testing tools for continuous testing.
• Manage defect tracking, root cause analysis, and resolution to ensure seamless delivery.
• Ensure compliance with security, accessibility, and regulatory standards for web platforms.

• Bachelor's degree in computer science or equivalent.
• Minimum 5 years' experience of working experience in software testing and 2 years in leadership role
• Proficiency with QA tools (e.g., Selenium, JIRA, Postman) and automation frameworks (e.g., Katalon Studio, pCloudy).
• Familiarity with Agile and Scrum methodologies, along with scripting or programming languages (e.g., Python, JavaScript).
• Experience with performance testing tools (e.g., JMeter, LoadRunner) and end-to-end QA for complex web applications.
• Strong leadership, problem-solving, and communication skills

· Perform incoming, in-process and outgoing quality control activities

· Liaise with customers pertaining product specifications and quality issues

· Update quality standards regularly in order to conform to customer’s requirements

· Perform in-coming, in-process and final QC daily activities

· File and update QC testing records or reports

· Review and verify daily routine QC results

· Liaise with Logistic Coordinator to arrange for outgoing shipment activities

· Report abnormalities to QA Supervisor

· Prepare quality related reports

· Take part in ISO 9001:2015 IQA activities

Any other duties and responsibilities assigned by the Company from time to time

Physically Fit, able to carry at least 10kg machine parts

Work Place : Pasir Ris (2 weeks training @ Woodlands)

Working Day : 5.5 days

Working Hour : 8.30am to 6pm, 8.30am to 12.30pm

OT available