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.

Note: This role requires frequent travel and will be based in China and Vietnam for at least 10 months per year. Proficiency in Mandarin is essential for effective communication with Chinese-speaking clients and stakeholders.

Key Responsibilities:

• Implement advanced monitoring systems to ensure product quality and optimize yield in electronics manufacturing.
• Proactively identify areas for improvement and develop strategies to enhance overall product quality.
• Lead initiatives to address and resolve abnormal quality issues within the manufacturing process.
• Collaborate with cross-functional teams to implement effective solutions and preventive measures.
• Drive efforts to improve internal quality control procedures and enhance process capability.
• Implement best practices to streamline processes and maximize operational efficiency.
• Lead initiatives to resolve customer-reported quality issues, ensuring timely and effective resolutions.
• Prepare detailed reports for stakeholders outlining corrective actions and preventive measures.
• Develop and implement strategies to optimize quality inspection processes.
• Identify opportunities for automation and technological advancements to enhance inspection efficiency.
• Foster open communication and collaboration across departments for effective quality management.
• Coordinate with various teams to ensure a unified approach toward achieving quality objectives.
• Manage personnel-related tasks, including task assignments, coordination, attendance, and performance management.
• Develop and implement training programs to enhance team skills and knowledge.
• Oversee the timely delivery of tasks and projects to meet quality objectives within established timelines.

Requirements:

• Bachelor’s degree in a relevant field; advanced degree preferred.
• A minimum of 6-8 years of proven experience in quality management, particularly within manufacturing processes.
• Strong analytical and problem-solving skills.
• Excellent leadership and interpersonal skills.
• Familiarity with quality management systems and standards such as TS16949 and VDA 6.3.
• Experience collaborating with counterparts in China/Taiwan.
• Certification in quality management (e.g., Six Sigma) is advantageous.
• Willingness to travel frequently and be based in China and Vietnam for at least 10 months per year (separate living accommodations provided). The role includes annual 4 round-trip tickets back to Singapore.

Job Description

Job Scope & Responbilities :

* Handle for full set of account

* Financial month end closing

* Coordinate and liaise with external parties like auditors, tax agents and tax authorities

* Responsible for all duties related to Human Resources,

* Monthly payroll preparation, CPF submission

* Responsible of IRAS AIS,IR8A, Corporate tax, Income tax etc.

* MOM WPOL/EPOL/ matter

* Handling other admin duties

* Perform any other ad hoc duties when required.

Job Requirements :

* Candidate must possess at least diploma or equivalent.

* Language: Bilingual in English and Chinese Mandarin (read, write and speak) as the incumbent needs to liaise with Mandarin-speaking associates in the course of work.

* At least 2 Year(s) of working experience in the related field is required for this position.

Note: This role requires frequent travel and will be based in China and Vietnam for at least 10 months per year. Proficiency in Mandarin is essential for effective communication with Chinese-speaking clients and stakeholders.

Key Responsibilities:

• Implement advanced monitoring systems to ensure product quality and optimize yield in electronics manufacturing.
• Proactively identify areas for improvement and develop strategies to enhance overall product quality.
• Lead initiatives to address and resolve abnormal quality issues within the manufacturing process.
• Collaborate with cross-functional teams to implement effective solutions and preventive measures.
• Drive efforts to improve internal quality control procedures and enhance process capability.
• Implement best practices to streamline processes and maximize operational efficiency.
• Lead initiatives to resolve customer-reported quality issues, ensuring timely and effective resolutions.
• Prepare detailed reports for stakeholders outlining corrective actions and preventive measures.
• Develop and implement strategies to optimize quality inspection processes.
• Identify opportunities for automation and technological advancements to enhance inspection efficiency.
• Foster open communication and collaboration across departments for effective quality management.
• Coordinate with various teams to ensure a unified approach toward achieving quality objectives.
• Manage personnel-related tasks, including task assignments, coordination, attendance, and performance management.
• Develop and implement training programs to enhance team skills and knowledge.
• Oversee the timely delivery of tasks and projects to meet quality objectives within established timelines.

Requirements:

• Bachelor’s degree in a relevant field; advanced degree preferred.
• A minimum of 6-8 years of proven experience in quality management, particularly within manufacturing processes.
• Strong analytical and problem-solving skills.
• Excellent leadership and interpersonal skills.
• Familiarity with quality management systems and standards such as TS16949 and VDA 6.3.
• Experience collaborating with counterparts in China/Taiwan.
• Certification in quality management (e.g., Six Sigma) is advantageous.
• Willingness to travel frequently and be based in China and Vietnam for at least 10 months per year (separate living accommodations provided). The role includes annual 4 round-trip tickets back to Singapore.

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

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

Authorities and Responsibilities

1. Responsible for providing directives for the Quality Assurance Department in meeting management objectives.
2. Formulate, implement and evaluate quality strategies programs for the company.
3. Implement and maintain a system of auditing the facility and periodic calibration of test, measuring equipment and tools.
4. Manage customer complaints, corrective and preventive action programs.
5. Administer and manage continuous improvement program for all QA processes.
6. Work closely with auditors, customers, production and suppliers to meet the quality requirements.
7. Manage sub-contractors for on-time supply of treatment process, as well as meeting technical requirement.
8. Review / prepare, administer and implement Quality Assurance Plans, Inspection Test Plans and other Operational procedures in accordance to the technical specifications, customer's surveillance requirements, and good manufacturing / engineering practices, and enforce the same on Operations in their execution.
9. Work closely among inter-department to ensure committed schedules are met in a timely and effectively manner.
10. Review and approve disposition program / action for nonconforming products.
11. Ensure that processes needed for the quality management system are established and implemented.
12. Report to top management on the performance of the quality management system, and note needed improvements.
13. Ensure the promotion of awareness of statutory, regulatory and customer requirements throughout the organization.
14. Ensure and coordinate the implementation of risk assessment and risk control of medical devices

The Quality Assurance Manager plays a crucial role in business by ensuring that products meet certain standards of quality. He/She plans, directs or coordinates quality assurance programs and formulate quality control policies. He/She also works to improve an organisation's efficiency and profitability by reducing waste. He/She prepares and update quality documentation, basing their processes on a recognised standard such as ISO 9000 – Quality Management, published by the International Organisation for Standardisation. He/She supervises teams of inspectors who carry out the detailed assessment of products and their components at different stages of production. He/She recruits and trains supervisors, and provides them with documented quality standards as guidelines for their daily work. He/She also selects quality inspection tools and software to support the inspection team.

Competence Requirements:

• Diploma in Mechanical Engineering / Quality Engineering or equivalent.
• Minimum 6 years of solid experience in Quality Management in similar or related industry and 3 years in management level.
• Good knowledge in implementing and up keeping Quality Management System.
• Strong leadership and good interpersonal skills.
• A team player with strong sense of responsibility to ensure plant effective quality performance.

~ Assist in the implementation of company quality systems.
~ Conduct Quality Assurance audit.
~ Manage cause investigation for non-conformance.
~ Manage company quality systems.
~ Manage departmental activities and deployment.
~ Able to commute between Tuas Plant and Loyang Plant.

Responsibilities (include but are not limited to):

· Work with the Manufacturing department as a production area Quality Assurance representative

· Coordinate and facilitate Quality Assurance related production and production related activities

· Ensure timely issuance of production records, procedures and labels

· Ensure timely assessment and closure of discrepancies, Deviations and Change Controls

· Review batch-related documentation, and ensure resolution of issues to release product

· Communicate lot disposition pending issues to Management

· Ensure approval and timely delivery of Final Product

· Ensure that products are manufactured in compliance with regulatory and GMP guidelines

· Review and approve Manufacturing and Validation documents for Regulatory and Kite compliance

· Review and approve Manufacturing Production Records

· Compile and verify all batch related documents into a Final Product lot disposition package

· Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues

· Review and disposition disposable raw materials and components for GMP use

· Review equipment and facility technical and investigation reports

· Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies

· Gather metric information for use in continuous improvement of areas of responsibility. Report to management as needed.

· Perform other duties as required

Requirements:

• Min Diploma / Degree in Chemical Process Technology, Foodscience, Biotechlonogy, Biology, Biomedical Sciences, Science or its equivalents
• No Experience Needed, Full training/ on the job guidance will be provided
• Able to start immediately

If you are interested in any of the positions, do kindly drop your most updated resume to [email protected] (Attn: QA Specialist)

Thank You.

Leon Leong De Cong
R1551708

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599

• Position: Quality Assurance QA/QC Engineer (MUST BE from Marine Engineering)
• Location: North Bridge Road (Walking distance from Fort Canning MRT Station)
• Working hours : 5 days / Monday - Friday - 9.30am -5.30pm
• Salary (Commensurate with experience): Basic up to $ 3700 + AWS + 14 days Annual Leave
• Duration : Permanent
• Industry : Global leader in Marine Lifting Equipment

Main Responsibilities:

• Perform inspection of incoming products, materials or customer items according to job project requirement
• Perform initial inspection and raise report
• Perform in-process inspection according to procedures and customer’s specifications. Raise report whenever necessary. Measure and record the dimension of components/parts using measuring instruments and analyse the findings for discrepancy
• Perform final inspection of items including dimensional and NDT to ensure that all quality requirements has been achieved. Analyse result and decide the acceptance level of the final product
• Prepare and conduct Project Specific Quality requirements training to production Supervisors and Sub-contractors QC Personnel.
• Establishing Work Procedures and Instructions.
• Support QA/QC Manager for establishing WPS, PQR and WQT Qualifications.
• Act as Project Lead QA/QC and control the entire project Quality Assurance and Control activities during construction phase.
• Oversees the Inspector’s performance on the project towards monitoring and control of workmanship towards quality.
• Updating of Inspection status and records on daily basis.
• Attend weekly client progress review, Internal and Sub-Contractors meeting to discuss Quality issues.
• Liaise with client in relation to Quality on Project Specific.
• Schedule and conduct Project Specific Quality Audit as per agreed Plan.

Requirements:

• Degree in Engineering or Diploma in Mechanical/ Marine Engineering or equivalent
• Experience in handling project Audit and liaise with internal & external auditor
• Knowledge in structural fabrication, piping isometric drawing and materials
• Experience in piping line walk, reinstatement inspections by clear understanding of isometric drawings

Email to: [email protected] or call me at: 6398 5689 for more information.

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Join us on Linkedin: www.linkedin.com/company/search-personnel-pte-ltd

***We do not charge our candidates any referral fee nor bind them with any contract.***

Jane Chua

Associate Consulting Director (APAC)

License no: 13C6684

EA Personnel: R2197224

Thank you for your interest in this position. Our shortlisting period is 3 working days. Only shortlisted candidates will be contacted for further consideration.

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 that you continue your job search to maximize your opportunities. We wish you all the best and should we have any suitable roles that match your experiences/ qualifications/ preferences, we will reach out to you.

As a Non-Volatile Memory Quality & Reliability Assurance (NVMQRA) Engineer at Micron Technology, you will be responsible for performing formal Failure Analysis of customer reported failing devices via the Returned Material Authorization (RMA) process. You will be required to summarize lab analysis results at the electrical and physical level to identify root cause and establish an associated containment plan. In this role, you will have the opportunities to collaborate with various engineering and manufacturing stakeholders to evaluate and review Corrective Actions /Preventive Actions. You will provide documentation of the RMA findings and oversee the final customer report till closure. In addition, for the senior role, you will be asked to provide guidance and lead the team when solving complex unplanned deviations reported by our customers. Project management skills are necessary and the ability to make critical decisions that directly translate to quality and timely completion of the project is highly desirable. You will also be required to spearhead the sustaining efforts and keeping up to date on new product knowledge, as well as developing and mentoring new talents.

Responsibilities and Tasks

Perform Failure Analysis of Customer Returns

• Understand customer complaint of the memory component failure
• Initiate communication with Micron Customer-facing team for further details on customer complaint, requesting additional questions to provide best opportunity for successful analysis
• Perform bench level analysis including initial data image analyis/examination
• Perform Automated Test Equipment (ATE) analysis and interpret results
• Work with the appropriate engineering teams (e.g., PE, PYE) to perform detailed fault isolation when electrical failure has been confirmed
• Summarize findings and submit for physical failure analysis (PFA).

Provide FA Reports for Micron Customer Facing Team for Communication to External Customers

• Summarize analysis at electrical and physical level into customer friendly formats.
• Work with the appropriate manufacturing Global Quality teams through the appropriate request systems (example: GPSS) for Root Cause and/or Corrective Action and a containment plan
• Identify potential risk to external customers
• Communicate with respective BU (Business Unit) on potential impact to customers
• Communicate FA updates through interim reports or during scheduled meetings with the customers.
• Provide formal FA Report with findings

Sustain Knowledge of Device Capabilities and Characteristics

• Keep up to date with latest Fab/ASM process technology
• Understand datasheet specifications for each device and the differences from previous technode for NOR * NAND product family
• Comprehension of qualification data and potential impact to customer operation
• Stay up-to-date on common customer applications and usage model
• Partnering with customer support team to resolve ongoing customer issues

Qualifications and Experience

• Excellent verbal and written communication skills in English. The ability to communicate clearly and concisely both verbally and in writing is critical in this role.
• Good organization skills and ability to multitask and coordinate between multiple issue at any given time.
• Ability to work effectively in cross-functional teams and handle pressure situations in a professional manner
• Excellent problem-solving and analytical skills with strong attention to details.
• Familiarity with NexTest /Teradyne bench analytical tools, scripting in linux console will be an added advantage.

Candidates with 2-3 years of experience in the semiconductor industry as Product or QA engineer are preferred. Relevant experienced candidates will be considered for the Senior Role.

Education

A Bachelor or Masters Degree in Electrical Engineering or similar field of study.

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

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.

Job Description

• To coordinates the process of product registration and market access approval in the designated countries including providing all required documents and certificates within the specified timeframe proactively to complete product registration.
• To provide advice to internal and external teams in interpreting relevant guidance documents and standards.
• To contact local authority and organization for both regulatory problems solving and obtain updated information on current and developing regulations.
• To review and approve documents to support Post Market Change notification (including labelling changes) to comply with international regulations and standards.
• To remain up to date on regulations and communicate any key changes to stakeholders in the broader organization.
• To provide training when necessary and assist with the development of the respective countries’ Regulatory Affairs infrastructure to facilitate greater speed to market.
• To take charge of QA (complaint reporting etc) for all subsidiaries.

Qualification

• Degree/ Diploma in Biomedical engineering or science or QA/RA related field
• Minimum progressive 3 years of QA/RA working experience in medical device manufacturing industry

Interested candidate, please email to [email protected]

Leon Leong De Cong

R1551708

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 99C4599

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.

The primary responsibility of this position is to provide leadership for all Quality Assurance & Control matters.

This includes:

• Assuring consistent quality of production by developing processes and enforcing compliance to ISO 13485 quality system.
• Validating the production & inspection processes and maintaining validation status
• Managing the records for Quality Inspection, Quality Control, Calibration, QA Lab equipment, Training Resources, ERP Quality Module and Quality System Documentation.
• Managing a team of Engineers, QA Technicians & Quality Inspectors

The incumbent reports to the Site Leader, Singapore and Global Head of Quality (Medevio).

Roles & Responsibilties

Quality System Management

• Manage and maintain the site's quality management system (QMS) in compliance with ISO 13485 and ISO 9001 and applicable regulatory standards.
• Key stakeholder in ERP in Quality Module and DMS of site
• Ensure that the QMS effectively supports all manufacturing and operational processes, resulting in consistently high-quality product outputs.

Quality Operation & Lab Management:

• Oversee the day-to-day operations of the quality control and assurance, ensuring proper procedures and outcomes that consistently align with product specifications.
• Manage a team on quality inspection and establishing protocols fulfilling both internal, external customers.
• Develop and enforce rigorous lab testing protocols to maintain stringent quality and safety standards.

Capital Expenditure Planning and Equipment Management:

• Plan and manage capital expenditure for quality-related equipment in production to support ongoing and new operations.
• Site calibration SME and coordinator for both internal and external calibration.
• Ensure timely maintenance and calibration of quality equipment to maintain operational efficiency and compliance with industry standards.

NPI and quality engineering:

• Ensure compliance with new and pre-existing product requirements.
• Key stakeholder in new product development including qualification to production readiness.

Global Quality:

• Working with Global Head of Quality to drive Global Quality Plan
• Working with peers in Global Quality to drive strategic global initiatives, ensuring cohesive quality management across Medevio Sites

Regulatory Compliance and Auditing:

• Oversee readiness for all internal and external audits, including customer audits and third-party regulatory audits.
• Lead the preparation and submission of documentation required for regulatory compliance in all markets where products are distributed.
• Develop and implement strategies to manage and reduce compliance risks.

Supplier Management and Incoming Quality Control:

• Oversee supplier quality management, conducting audits and addressing issues to ensure supplier compliance with quality standards.
• Develop and maintain strong relationships with suppliers to ensure continuous supply chain improvement and adherence to quality specifications.

Quality Improvement Initiatives:

• Identify opportunities for process improvements and lead quality improvement projects to enhance manufacturing efficacy and product quality.
• Drive the transformation towards a paperless factory to enhance operational efficiency and data integrity.
• Implement Statistical Process Control (SPC) to monitor and control quality during manufacturing processes.
• Utilize digital tools and methodologies such as Six Sigma and lean manufacturing to improve productivity and product quality.

Team Leadership and Development:

• Manage and lead a team of skilled quality engineers and technicians, providing strategic direction, training, and development.
• Foster a culture that prioritizes quality and compliance through continuous training, learning and development programs, and succession planning.

Stakeholder Engagement and Reporting:

• Align with the global quality function on strategic global initiatives, ensuring cohesive quality management across the organization.
• Collaborate closely with manufacturing, R&D, and supply chain departments to ensure alignment on quality standards and to address quality issues promptly.
• Report on quality metrics and KPIs to senior management, providing insights and recommendations for ongoing quality enhancements.
• Communicate effectively with customers and regulatory bodies regarding product quality and compliance issues.

Complaint and CAPA Handling:

• Lead the investigation and resolution of non-conformance issues and product incidents, identifying root causes and implementing corrective actions.
• Manage the customer complaint process, ensuring all complaints are addressed promptly and effectively.
• Lead the development and completion of 8D reports, ensuring thorough documentation and effective resolution of issues.
• Oversee the implementation of corrective and preventive actions (CAPA) to eliminate the causes of potential non-conformities or issues, preventing their recurrence.

Environmental Health and Safety (EHS) and Sustainability:

• Support the development, implementation, and enforcement of an EHS policy, complying with all legal and corporate policies.
• Assist in fostering a culture of safety responsibility, providing ongoing training and resources to ensure a safe and healthy work environment.
• Support the establishment and execution of site ESG goals in alignment with Medevio's global sustainability roadmap, ensuring the site contributes effectively to broader corporate sustainability targets.

Qualifications

• Bachelor’s in Engineering or Science / Master’s in Engineering or Science
• Extensive experience within a manufacturing environment with a thorough understanding of ISO 13485 and ISO 9001.
• Six Sigma certification and/or ASQ certified Quality Engineer

• 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

We are looking for one technically strong and motivated Manager to support the Assurance R&Q Independence Office.

How will you value-add?

• Provide consultation advice to professionals from various Lines of Service, who seek input for a variety of personal, system and engagement-related independence queries
• Conduct various independence compliance activities such as:
  1. Personal independence compliance testing
  2. Run the Annual Compliance Confirmation activity
  3. Data quality reviews
• Assist in management of independence systems
• Provide support in collation of information and statistics for local, global and regulatory reporting purposes
• Develop relevant independence practice aids, templates and training materials to aid professionals in the firm in complying with independence requirements
• Project manage global or local initiatives as required

About you

• Audit experience preferred
• Have good project management skills
• Possess high level of accuracy and attention to detail
• Have strong analytical & problem-solving skills
• Enjoy meeting people and have the confidence and maturity to deal with all levels of staff
• Has the willingness to learn and deliver timely and quality results

Job Description

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

Job Requirement

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

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

Responsibilities

• Foster a culture of innovation by encouraging experimentation and calculated risk-taking.
• Lead and manage the R&D department by developing and implementing effective technical strategies.
• Drive product management initiatives to enhance customer satisfaction, improve productivity, elevate product quality, and reduce manufacturing costs.
• Provide technical direction for product development, support, and certification processes.
• Ensure compliance with applicable airworthiness requirements and secure necessary approvals from relevant authorities.
• Act as an authorized design signatory for certification and design data with major aircraft manufacturers.
• Collaborate with cross-functional teams to identify business opportunities and develop innovative solutions.

Requirements

• Candidate must have minimum of 8 years working in aviation R&D, product development, or engineering management.
• Minimum Degreein Engineering or Quality Assurance or related field.
• Comprehensive understanding of aviation regulations and standards (e.g., FAR, EASA, CAAS).
• Extensive knowledge of product lifecycle management (PLM) principles.
• Proven working experience in leading a team.

Thank you for your application and we regret that only shortlisted applicants will be notified

By submitting any application or resume to us, you will be deemed to have agreed & consented to us collecting, using, retaining & disclosing your personal information to prospective employers with the services provided by us.

EA (18C9514/R23118479)

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)

Responsibilities:

1. Oversee effective implementation of the Quality Management System throughout the Company.
2. Coordinate the review of quality procedures associated with continuous improvement initiatives in the Plant.
3. Ensure that all in-house systems and procedures are updated, revised and modified to meet statutory requirements and the needs of external certification bodies.
4. Organise and manage the internal audit system and the corrective action reporting system.
5. Host external Quality System audits. Manage the audit program to ensure that all nonconformities raised by certification bodies during audits are effectively corrected and independently verified.
6. Communicate with personnel at all levels, internally and externally to the Company, in relation to quality system matters.
7. Oversee effective implementation of Halal Quality Management System throughout the company and coordinate Halal certification programme.
8. Assume the role of a Qualified Person (QP) to oversee the export process. Ensure the compliance of the export consignments with importing countries’ requirements and submit declarations to the Singapore Food Agency.

Requirements:

1. Bachelor's degree in Food Science or related Degree and a minimum of 4 years of working experience in a food manufacturing environment.
2. Must have strong knowledge of the Halal food system, GMP, HACCP, ISO 9000, ISO 22000 and food safety regulations; including gap closure on audit findings.
3. Proficient in Microsoft office.
4. Posses excellent verbal and written communication skills.
5. Detail oriented, takes initiative, resourceful and adaptable.

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too.

EY Assurance group is one of the most trusted, respected and influential business unit in the industry. As part of our team, you will provide our clients including companies, investors and regulators a peace of mind by using your skills and experience to them confidence in the validity of financial statements and business-critical information or processes. Groups (or, as we call them, sub-service lines) within Assurance include External Audit, Climate Change and Sustainability Services, Financial Accounting Advisory Services and Fraud Investigation & Dispute Services.

Join our External Audit team and you will help our clients meet their reporting requirements by providing an objective and independent examination of their financial statements. In addition, you will conduct timely and constructive discussions with the management on accounting and reporting matters and provide a robust and clear perspective to audit committees.

The opportunity

You will experience professional development through diverse experiences, world-class learning and individually tailored coaching. That’s how we develop outstanding leaders who team to deliver on our promises to all of our stakeholders, and in so doing, play a critical role in building a better working world for our people, for our clients and for our communities. Sound interesting? Well this is just the beginning. Because whenever you join, however long you stay, the exceptional EY experience lasts a lifetime.

Your key responsibilities

· Support the planning, execution and delivery of assurance engagements.

· Clearly and accurately document the execution of specific audit procedures as defined by the engagement objectives, audit client's engagement history, and planned audit approach.

· Recognize potential audit issues or unusual relationships from basic analysis of the financial statements and communicate them to the assurance team.

Skills and attributes for success

· Work effectively as a team member, sharing responsibility, providing support, maintaining communication and updating senior team members on progress.

· Contribute ideas/opinions to the assurance teams and listen/respond to other assurance team members' views

· Demonstrate professionalism and competence in the audit client's environment.

· Strong written and verbal communication skills

· Good project management skills

· Integrity within a professional environment

To qualify for the role you must have

· A degree in Accountancy/ Business related.

· Min 3 year's relevant work experience in the audit field

Ideally, you’ll also have

· Prior working experience in global professional services organization or mid-tier firms will be highly advantageous

What we look for

Highly motivated individuals with excellent problem-solving skills and the ability to prioritize shifting workloads in a rapidly changing industry. An effective communicator, you’ll be a confident team player that collaborates with people from various teams while looking to develop your career in a dynamic organization.