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

• A Bachelor Degree in Science / Chemical Engineering or equivalent with relevant pharmaceutical experience.
• Minimum 1-3 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]

Tricia Celestine Goh (R1981653)

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

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.

For more information, please visit www.beyondsoft.com.

RESPONSIBILITIES

• To understand quality requirements and standards and verify conformance in production line.
• To analyse audit findings to minimise process non-conformances in the production line.
• To accurately record and communicate observations from audit/inspection to affected parties and team.
• To inspect sub-assemblies and finished product, both visually and functionally.
• To work in factory environment, which will involve walking around with appropriate attire and safety PPE.
• To observe required factory and safety rules, when performing daily duties.
• To provide accurate reports to engineers and managers on a timely basis.
• To provide suggestions for improvements or highlight challenges encountered.

• Minimum ITE certification with at least 1 year of experience.
• Proficient in Microsoft Excel, Word, PowerPoint, and Outlook.
• Able to work independently with minimal supervision.
• Willing to learn new skills, with passion for quality.
• Troubleshooting skill knowledge will be an advantage.

Job Description & Requirements

• Ensure compliance with industry standards and customer specifications.
• Inspect and verify the accuracy, precision, and overall quality of the manufactured parts.
• Use measuring instruments like calipers, micrometers, and coordinate measuring machines (CMMs) to verify the dimensions and tolerances of parts.

Requirements:

• Strong knowledge of CNC machining processes and equipment
• Proficiency in using measuring instruments
• Attention to detail and problem-solving skills
• Ability to read and interpret engineering drawings and specifications
• Strong communication and interpersonal skills
• Knowledge of quality control tools and techniques, such as statistical process control (SPC)

Interested candidates who wish to apply for the advertised position, please click on the APPLY button below to send in your resume to [email protected]

EA License No: 13C6305

Reg. No.: R1981808

For candidate who applied for the advertised position is deemed to have consented to us that we may collect, use or disclose your personal information for purpose in connection with the services provided by us.

1. Perform daily periodic checks of Central Kitchen to ensure compliance to in-house GMP/GHP standards, SOP, Product Specifications, etc.

2. Conduct random checks on incoming raw materials, and perform product cutting on raw materials to ensure goods received are within in-house specifications.

3. Ensure Process Verification and Validation exercise are completed (i.e. SOP/CCP verification, new product launch process observation, monthly facility checks, monthly traceability exercise, finished goods shelf-life verification, etc.)

4. Conduct investigations on product/process non-conformance (on-line and customer complaints) and follow-up on proposed corrective/preventive measures to ensure effectiveness.

5. Promptly follow-up with contractors (chemical/pest control) during routine servicing to ensure work orders are conducted as per contract.

6. Participate and engage in quality system implementation (audit activities by regulatory/certification bodies and customers).

7. Conduct data/trend analysis on non-conformity of raw material/finished goods, pest reporting statistics, monthly production and facility check statistics, etc. for process and quality improvement.

8. Ensure analysis of food products via microbiological and physical testing, calibration of lab equipment and measurement tools, internal sensory evaluation are conducted as per schedule.

9. Report all non-conformances, discrepancies and/or deviations, and follow-up on the investigation of the non-conformity results.

10. Other projects as assigned.

Key Responsibilities:

• Conduct regular quality checks on processes and claims to ensure adherence to company standards.
• Develop and implement quality assurance guidelines and best practices for operational procedures.
• Monitor and evaluate customer interactions and claims to ensure compliance with internal and regulatory standards.
• Identify areas for improvement and work collaboratively with teams to enhance quality and operational efficiency.
• Prepare and present reports on quality performance, highlighting trends and actionable insights.

Qualifications:

• Prior experience in quality assurance within the insurance industry is preferred.
• BCP and PGI Certs will be advantageous
• Strong analytical skills and attention to detail.
• Excellent communication skills and ability to work collaboratively across teams.

EA Personnel Name: Izz Bin Lokman
EA Personnel No: R24124828
EA License No: 05C3451

Job Responsibilities :

• Qualification/Validation Support:Assist in site projects related to qualification and validation.
  
• Document Review & Approval:Review and approve documents for Quality Control (e.g., Analytical Instrument Qualification, Method Validation, Critical Reagent Qualification).
  Ensure compliance with internal procedures and regulatory requirements.
  Evaluate and approve discrepancies in qualification/validation protocols and document corrective actions.
  
• Collaboration & Project Support:Act as Quality Representative for Quality Systems and Validation in projects.
  Provide validation expertise during development or modification phases of qualification activities.
  
• Quality Oversight:Ensure documentation of qualification/validation is clear and defendable during inspections.
  Provide oversight for Quality Control validation maintenance and Master Validation Plan.
  
• Multisite Coordination:Support harmonization of Quality Systems and validation activities across plants.
  
• Cross-Department Collaboration:Foster strong partnerships with other departments to ensure open communication.
  
• EHS & Conduct:Adhere to Environmental, Health, and Safety (EHS) requirements.
  Maintain behavior in accordance with Shire’s Code of Conduct.
  
• Other Duties:Perform any additional tasks as assigned by Manager/Supervisor.
  

Education and Experience Requirements:

• Education: Degree in pharmaceutical sciences, life sciences, biology, biotechnology, chemistry, chemical engineering, or a related field. Additional certifications (e.g., Certified Quality Engineer, Validation topics) are a plus.
• Experience:2-3 years in pharmaceutical or biotechnology quality assurance, manufacturing, or validation (preferably in a multinational company).
  Hands-on experience with equipment, process, cleaning, computer systems, and shipping validation is an advantage.
  
• Regulatory Knowledge:Understanding of FDA/EU cGMP requirements (e.g., CFR 21 Part 11, PAT), ICH guidelines, and validation guides (e.g., PDA, ISPE GAMP).
  
• Problem-Solving & Communication:Ability to solve problems efficiently and interact diplomatically with diverse personalities.
  

Competencies:

• Study and understand Standard Operating Procedures (SOPs).
• Approve study, specification, and qualification/validation documents.
• Handle complex qualification/validation discrepancies.
• Assess internal procedures and external regulations
• Strong communication and organizational skills.

Requirements:

• Min Bachelor in any Science discipline
• Additional certificates such as Certified Quality Engineer would be advantageous
• Experience in biotechnology/pharmaceutical in QA/manufacturing operations preferred.
• Ability to work hands-on
• FDA/EU cGMP validation requirements and good understanding of ICH guidelines
• Critical thinking and problem solving skills

For interested candidates, please send your most recent and updated resume to [email protected]

WA me at http://wa.me/+6596698692

Alicia Cheong Ling Wei

R1104785

Recruit Express Pte Ltd

EA License No. 99C4599

Temus was established by Temasek in partnership with UST, to provide digital transformation solutions for the private and public sectors as we aspire to be a strategic partner in realising the Singapore Government’s Smart Nation vision. We are headquartered in Singapore and have more than 400 employees across a wide range of disciplines in strategy, design, architecture, technology, data & AI.

Job Overview:

We are seeking an experienced and highly motivated Quality Assurance Lead to spearhead the Quality Assurance (QA) pillar within our Digital Transformation Office. The successful candidate will play a pivotal role in ensuring the quality, cybersecurity, and compliance of domain products align with the client's standards. This leadership position requires a strategic thinker with a strong background in QA methodologies, cybersecurity practices, and compliance frameworks.

Responsibilities:

1. Define and Develop Controls, Procedures, and Metrics:

• Develop and implement an overall QA strategy aligned with the client’s goals and objectives.
• Lead the definition and development of controls, procedures, and metrics for quality, security, and compliance during the development and sustainment phases. (in areas like DevOps, CICD Pipeline, Functional Testing, Security Vulnerability etc)
• Communicate and harmonize these controls, procedures, and metrics across projects/products delivery teams to ensure consistency and alignment with client standards.
• Identify areas for process improvement and implement best practices to enhance efficiency and quality.

2. Independent Quality Assessment:

• Conduct independent quality assessments on domain products, collaborating with project/product delivery teams to address findings and mitigate risks.
• Be accountable to the client's Governance Board for product acceptance and deployment release, including the clearance of vulnerability assessment reports.

3. Periodic Compliance Checks:

• Conduct independent periodic compliance checks on selected systems annually, post system go-live, based on applicable standards, policies, and directives.
• Identify risks and compliance issues, submit reports detailing findings and recommendations, and track the rectification progress by project/product teams until closure.

4. Continuous Improvement:

• Drive continuous improvement efforts to enhance IT quality, security, and compliance for domain product delivery.
• Identify opportunities for improvement and suggest recommendations, including the exploration of automation tools and methods to streamline processes.

5. Risk Management:

• Identify and assess potential risks to the quality of software products and develop mitigation strategies.
• Work proactively with key Project Members e.g. Project Manager and Test Manager to prevent and address quality issues throughout the development lifecycle.

Job Requirements/ Qualifications:

• Bachelor's or Master's degree in Computer Science, Information Technology, or a related field.
• Minimum 10 years of experience in project delivery role for IT/ Consulting domain
• Proven experience (min 5 years) in a leadership role within Quality Assurance, focusing on product quality, cybersecurity, and compliance.
• In-depth knowledge of QA methodologies, cybersecurity best practices, and compliance frameworks.
• Strong understanding of controls, procedures, and metrics used in software development and sustainment.
• Experience with vulnerability assessment and resolution processes.
• Excellent communication and collaboration skills to work effectively with cross-functional teams.
• Proven track record in driving continuous improvement initiatives.
• Relevant certifications (e.g., CISSP, CISM, ISTQB) will be a plus.
• Public Sector experience will be advantageous

By applying for this role, you have read and acknowledge the data privacy statement via this link - https://www.temus.com/job-applicant-data-protection/

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

• A Bachelor Degree in Science / Chemical Engineering or equivalent with relevant biopharmaceutical/ pharmaceutical experience.
• Minimum 2 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]

Tricia Celestine Goh (R1981653)

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

Mon to Fri 8.30am - 5.30pm

Job Summary

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

Role and Responsibilities

Quality Systems

1. Supports overall maintenance of quality systems

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

3. Maintains the Master control and ISO document control system

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

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

Quality Policies

6. Ensures effective implementation of all company quality policies

7. Implements ISO and other recognized standards

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

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

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

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

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

Auditing

13. Leads ISO quality standards implementation as Management Representative.

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

15. Leads customer related audits

16. Conducts supplier audits

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

18. Responsible for ensuring timely resolution to audit findings

Training

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

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

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

Job Requirements:

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

• Certificate in Quality Engineering is preferred.

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

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

• ISO 13845 experience will be added advantage.

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

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

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

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

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

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

• Candidate must possess at least Bachelor's Degree/Post Graduate Diploma/Professional Degree in Engineering(Civil) or equivalen.
• At least 2 years(s) of working experience in the related field is required for this position.
• Required Skill(s): Understand drawing, Quantity take off, Prepare BQ, Familiar with costing, Supplier sourcing, Contract administration.
• Preferably Senior Executive specialized in Engineering-Civil/Construction/Structural or equivalent.
• Familar with structural steelworks.
• Other QS duties as assigned from time to time.

Roles and Responsibilities (Software Quality Engineer)

a. Assist Product Owner, Business Analyst to craft out user story acceptance criteria

b. Analyse and decompose complicated software systems, and design a holistic test strategy

c. Conduct research on emerging technologies and develop test automation framework

d. Develop test suites of test scenarios and test cases

e. Take a risk-based approach for test automation

f. Perform time boxed exploratory testing

g. Maintain regression test suite in QA nightly build

h. Actively refine smoke test suite in Development CI environment

i. Lead system integration testing with other systems

j. Manage user acceptance testing

k. Manage defect life cycle, test artefacts and repository

l. Drive continuous improvement in agile testing practices and tools

m. Take on secondary role as low code application development engineer or Security Ops Engineer

n. Improve software quality using XP practices such as code review and unit testing

o. Understand the IT management policy, quality management policy and security guidelines to ensure the development processes, procedures and system are designed to comply with these policies and guidelines

Knowledge and Skills (Software Quality Engineer)

a. Degree or Diploma in Computer Science, Computer or Electronics Engineering, Information Technology or related disciplines.

b. Min 3 years’ experience in exploratory testing and regression test automation

c. Strong analytical skills

d. Meticulous attention to details

e. Good interpersonal skills such as tactfulness

f. Good presentation and listening skills

g. Experience in agile development environment will be an added advantage

h. Experience with Robot Framework, SikuliX, Selenium, playwright, Micro Focus Testing Tools (Mobile Center, UFT, QC and Sprinter) or EggPlant or Pega Unit Test will be an added advantage

i. Certified Software Testing Professional and/or Certified Software Quality Analyst will be an added advantage

Roles and Responsibilities (Software Quality Engineer)

a. Assist Product Owner, Business Analyst to craft out user story acceptance criteria

b. Analyse and decompose complicated software systems, and design a holistic test strategy

c. Conduct research on emerging technologies and develop test automation framework

d. Develop test suites of test scenarios and test cases

e. Take a risk-based approach for test automation

f. Perform time boxed exploratory testing

g. Maintain regression test suite in QA nightly build

h. Actively refine smoke test suite in Development CI environment

i. Lead system integration testing with other systems

j. Manage user acceptance testing

k. Manage defect life cycle, test artefacts and repository

l. Drive continuous improvement in agile testing practices and tools

m. Take on secondary role as low code application development engineer or Security Ops Engineer

n. Improve software quality using XP practices such as code review and unit testing

o. Understand the IT management policy, quality management policy and security guidelines to ensure the development processes, procedures and system are designed to comply with these policies and guidelines

Knowledge and Skills (Software Quality Engineer)

a. Degree or Diploma in Computer Science, Computer or Electronics Engineering, Information Technology or related disciplines.

b. Min 3 years’ experience in exploratory testing and regression test automation

c. Strong analytical skills

d. Meticulous attention to details

e. Good interpersonal skills such as tactfulness

f. Good presentation and listening skills

g. Experience in agile development environment will be an added advantage

h. Experience with Robot Framework, SikuliX, Selenium, playwright, Micro Focus Testing Tools (Mobile Center, UFT, QC and Sprinter) or EggPlant or Pega Unit Test will be an added advantage

i. Certified Software Testing Professional and/or Certified Software Quality Analyst will be an added advantage

Mission

• Plan and implement the Project Quality Management System (PQMS) activities within the project and organization.
• Plan and ensure the project Quality Control (QC) activities implementation
• Report Quality information and data about Project in line with Corporate Guidelines
• Act as focal point for quality related matters within the project and in liaison with external entities.
• Act as Auditor Lead for ISO matters.

Major Duty and Tasks

• Ensure the definition and implementation of the PQMS and the identification, preparation and distribution of needed Project Quality Plans and procedures in accordance with the Company and External Parties Quality Management System (QMS)
• Ensure that the integrity of the Company QMS is maintained when changes are made to the system for the project
• Ensure that the correct implementation of the Project QMS is checked and monitored through the planning of quality audits
• Ensure that the correct implementation of planned quality audits, taking in account all project processes, including the issue of relevant audit reports
• Ensure, within the project organization, the planning of activities aimed at promoting the applicable Contractual Quality Requirements
• Conduct external audit to Vendors and Subcontractors QMS and ISO requirements
• Ensure, within the project organization, the planning of activities aimed at promoting the applicable Contractual Quality Requirements
• Plan and allocate Quality resources to the various area of the project, managing them in liaison with involved Quality functions
• Support the Project Manager in relations with the Client and with the Authorities responsible for quality matters
• Participates to Project Management meetings, to ensure coordination between Quality activities and Project Management activities
• Ensure the preparation and issue of QC specifications for the works, coordinating and agreeing the checks by the Technical Departments and Client
• Ensure the issue of quality requirements to be incorporated, in the contractual documents, with Vendors and Subcontractors and organizations in charge of works
• Ensure the Site QC activities implementation, including the monitoring of QC management tool updating
• Ensure management of nonconformities
• Promote appropriate actions in order to prevent or eliminate potential non-conformities and their causes
• Ensure the management of Cost of Non Quality process
• Ensure knowledge and awareness of Quality requirements within the Project Team, also performing Quality Training activities
• Collect and analyse project quality data also to organize and lead the Project Quality Management Review
• Ensure the management of lessons learned process
• Ensure Customer satisfaction process implementation
• Report Project information and data to Company's Quality Manager by means of Corporate methodologies and tools and keep the Project Quality Reporting tools updated.
• Providing leadership, mentorship, and direction of all QA/QC personal.

Additional Requirements

• Ability to read PID’s and Isometric drawings.
• Understand NDT techniques.
• Experience with Ferrite and PMI techniques
• Knowledge of WPS/PQR activities
• Knowledge of Painting
• Familiar with AWS/ASME/ANSI codes and standards
• Experience with general Oilfield fabrication products
• Maintain the required test records and update accordingly.
• Conduct incoming and outgoing inspection activities such as inspecting the final output, comparing it to the requirements, and approving or rejecting the final products.
• Monitor the welding, NDT and etc activities.

Requirements:

• Diploma/Degree in relevant/related fields
• Min 10 years of QC inspection experience for Water, Oil and Gas fabrication
• Inspection Qualifications eg: CSWIP or equivalent
• Able to communicate with various level of people
• Good in verbal and written English
• General computer knowledge is essential (MS word, excel, powerpoint, MS outlook)
• Willing and able to travel overseas

Location: Jurong Pier (Transport pickup from Lakeside)

Salary Rage: Up to S$4,000 + AWS + VB

Working hours : 8.15am – 5.30pm (Mon-Thurs)/ 8.15am – 5pm (Fri)

Responsibilities:

• Support in the maintenance of Safety, Quality, Environmental, and Health Management Systems such as ISO 9001, ISO 14001, ISO 45001
• Support in the implementation of IATF 16949 quality standards.
• Ensure IATF core tools are effectively established in quality assurance process in compliance with IATF 16949 standards.
• Analysis of quality data to identify potential systemic issues & initiate improvements.
• Conduct internal audits, identify non-conformances, and lead corrective actions to ensure ongoing compliance with ISO and IATF standards.
• Other ad hoc duties assigned.

Experience & qualification

• Diploma or Degree in Manufacturing/Mechanical Engineering/Quality or equivalent
• Minimum 3-4 years relevant experience
• Proven experience in Quality Assurance (preferably in manufacturing environment).
• Strong knowledge and ability to apply core tools under IATF 16949 requirements.

Interested applicants please send your resumes to [email protected]

Jessica Nguyen Huynh Thanh Truc

Recruiter (R23113787)

EA License No. 99C4599

We regret that only shortlisted candidates will be notified.

We are representing our client in the Shipping industry to look for an experienced Quality and Assurance Executive to ensure the effective implementation, monitoring, and continual improvement of quality, health, safety, and environmental (QHSE) standards across the fleet and office operations.

This role supports compliance with international maritime regulations, industry best practices, and company policies to ensure safe, sustainable, and efficient operations. Assist to evaluate and upgrade the quality of ship management with stringent application of strong SMS system fleet wide.

Responsibilities:

• Responsible for ISM / SMS system including: Formulation & Review of SMS system; Implementation of current or/and revised Policy/Procedure; Promote a proactive safety culture across.
• Assist in conduct of internal audits and prepare vessels and offices for external audits by flag authorities and classification societies.
• Responsible for vessel & office evaluation pertaining to SMS implementation.
• Responsible for implementation of current/new regulations / guidelines.
• Responsible for managing KPIs assigned to Marine division of Ship management.
• Lead or participate in incident investigations to identify root causes and recommend corrective actions.
• Maintain accurate records of QHSE performance indicators and coordinate initiatives to improve the QHSE management system.
• Lead change management initiatives focus on QHSE improvements and innovations.

Requirements:

• Bachelor’s degree in Maritime, or related field (or equivalent maritime qualification).
• Sailing experience as an Officer / Master or Shore Experience in QHSE role for at least 1 year required
• Extensive knowledge of ISM Code, MARPOL, SOLAS and other relevant maritime regulations.
• Familiarity with incident investigation techniques (e.g., Root Cause Analysis, HAZID/HAZOP).
• Strong understanding of maritime operational and regulatory requirements.
• Proactive mindset with a strong focus on continuous improvement and innovation.
• Proficient in MS Office Suite and QHSE management systems.
• Ability to network professionally with stakeholders at an appropriate level.
• Willingness to provide emergency response support outside normal working hours.
• Demonstrated leadership skills with the ability to motivate multifunctional teams.
• Strong influencing skills and the ability to positively challenge processes to drive change.

Support day-to-day training administration for the Company. Interacts with all levels of staff in the Company with regards to in-house training, external training, on-the-job training and education.

Training Needs Analysis and Training Plan

• Compile the Training Needs for the year
• Analyze the training needs of staff and develop a total training plan yearly
• Educate or provide awareness training on Training Needs Analysis as required

Training Management and Communication

• Upkeep of all staff training records
• Conduct/Coordinate on training such as ISO9000, AS9100, ISO14000, OHSAS18001, Technical training, Soft Skills & etc.
• Assist in program design and development for in-house training
• Source, evaluate and engage external consultants for selected training programs
• Create training awareness & schedule through internal promotion, intranet & etc.
• Liaise with government institution for training grants or subsidies
• Review and recommend policies and procedures to increase the effectiveness and efficiency of the people development functions
• Control and monitor the total training budget for the company
• Set up an information system for the people development function to provide pertinent feedback to management

Training Evaluation

• Compile all training evaluation results after each training
• Provide monthly reports on training results, expenditure & etc.
• Develop and evaluate all four levels of training and ensure prompt feedback of information
• Provide half-yearly training report on the Total Training Plan and its effectiveness
• Comply with the ISO9001, AS9100, ISO4001 & OHSAS18001 Management system

Other Tasks

• Familiar with Quality Control Circle criteria and able to conduct and facilitate the teams.
• In charge of Staff Suggestion Scheme and ensure all employees to participate during Quality month
• Involve in GHG reduction activities
• Submit OHS & HSE data to HQ quarterly
• Other tasks assigned by superior.
• Ensure implementation of people development policies and procedures
• Timely compilation of Training Needs Analysis of the company yearly
• Implementation of training identified in the Total Training Plan
• The Company Education budget is appropriately used

Requirements:

• Degree in Business Administration with 2 years related experiences or Diploma in Training & Development with 4 –5 years training experience
• Possess good interpersonal skills
• Good oral & written communication skills
• Able to work as a team player
• Knowledge in People Developer Standard & it’s requirements
• Computer literate & proficient in MS Office
• Good understanding of Training Fund on all government statutory board requirements
• Stand up training experience is essential.

5 days work week

Bedok Area

Manufacturing Co.

Interested candidates, please forward a detailed resume and email to [email protected]

Tempserv Pte Ltd
License No: 06C3745
Attention: Audris Teo / EA Personnel No: R1102063

We are hiring Quality Engineer 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.

Mon to Fri 8.30am - 6pm

Position Summary

This position play a critical role in driving compliance and quality programs for Healthcare Transportation & Facilities and supporting the Healthcare Quality Management System to ensure processes and systems are compliant with regional and local regulations and customer requirements.

Job Scope

1. Quality Policies & Procedures: Determine, implement & promote policies and procedures for company’s Network and facilities (hubs & stations) to ensure compliance to standards such as GDP, GCP and others.

2. Quality Assessment & Standards: Write & review SOPs and Work Instructions for transportation & fulfilment solutions pertaining to the healthcare industry.

3. Compliance & Quality Program Management: Implement compliance and quality programs to support local Quality teams to ensure they are kept up-to-date and prepared.

4. CAPA Process Management: Lead in process creation and review of documentation on the implementation and responses to corrective and preventive actions (CAPAs) and monitor action progress until closure.

5. Healthcare Quality Management System: Develop, implement & support the system and processes, develop corresponding training programs, and acts as Super User for eQMS system.

6. Internal Audit Programs: Design & implement robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits.

7. Certification Audits: Lead various certification audits with relevant regulatory agencies and certification providers across the region.

8. Operations & Customer Audit Programs: Lead & prepare for regular audit programs / random checks / regulatory activities to achieve successful audit outcomes and proper post audit follow up actions.

9. Healthcare Customer Liaison: Liaise with customers to understand quality requirements / issues / underlying concerns to advise on the way forward, provide advice based on interpretations as applicable to 3PL and resolve issues via conducting root cause analysis.

10. Healthcare Quality Feedback: Liaise, consolidate feedback from different functions to update and prepare final copy for Quality Questionnaires, Agreements and RFQ Proposals for customers.

11. Validation Programs: Lead the validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems.

12. Depot Support: Provide secondary / backup support to healthcare specialists for market depots.

Requirements :

1. Hold local pharmacist license

2. Have at least five (5) years of relevant experience in warehouse, quality + QMS for pharmaceutical / healthcare industry

3. Have competencies in quality assurance / regulatory affairs, customer relationship management and root cause analysis

4. Have working experience ensuring compliance in accordance to Goods Manufacturing Practise cGMP,)/, Good Clinical Practises cGCP, Goods Distribution Practice (GDP) & ISO13485 for Medical Devices, IATA CEIV and other local certifications in a warehouse and transportation business.

5. Experience in conducting external and internal audits for regions

6. Must hold at least Bachelor’s degree in Pharmacy from a reputable local or Australia’s institute.

7. This position require to communicate with counter part in China

8. Occasionally travel is required to sites and region warehouses.

Competency

1. Accuracy & attention to detail which is crucial to proper compliance to regulatory and standards

2. Problem-solving skills to support customer issue resolution

3. Planning & organization skills to ensure proper audit programs are managed effectively

4. Communication skills to facilitate engagements with customer and regulatory agencies

5. Project management capabilities and familiarity with Process Mapping, Six Sigma, Lean Methodology, Agile or Design Thinking

6. Apply data-driven decision making with the use of data analytics and visualization tools like Power BI and competency in Microsoft Office applications like Excel, Word, and PowerPoint

Position Responsibilities

• Provide quality assurance support and review areas of manufacturing operations, product development, or field/ product quality.
• Ensure that facilities, equipment, materials, processes and product readiness comply with cGMP practices.
• Serve as Quality representative on project teams for reviewing the new product design transfers and/ or line transfers.
• Review and align manufacturing operational activities, such as Work instructions, Device History Records, Nonconformances, CAPA, RMA, and customer complaint investigations.
• Identify and drive resolution of quality issues in Quality Management System and/ or manufacturing operations.
• Work with cross-functional teams to resolve operational quality issues.
• Trend, analyze and monitor key performance indicators, suggest improvements and escalate to supervisor/ management as necessary.
• Participate in customer complaints and work closely with cross-functional teams to investigation issue and ensure timely response to corporate/ customer.
• Work in accordance with procedures and integrated program plans to achieve and maintain the required level of product quality in preparation for FDA and ISO third party audits.
• Support product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders
• Review verification and engineering study reports and identify gaps for GMP compliance. Develop and execute strategies to close gaps in an efficient, technical, and compliant manner
• Coordinate issue resolution using a risk-based approach

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Position Requirements

• Minimum of 1-2 years of related experience in manufacturing, quality assurance, and/ or process validation in a regulated environment. Fresh graduates can be considered.
• Bachelor's Degree in Biology, Biochemistry, Chemistry or equivalent field is preferred.
• Experience in the medical devices / IVD / biotech / pharmaceutical industry, or instrument hardware / software integration is an advantage.
• Good interpersonal, verbal and written communication skills.
• Familiar with 21 CFR 820 and ISO 13485 requirements.
• Familiar with words processing, spreadsheets and presentation tools.
• Familiar with failure investigation, technical report writing, data mining, trend analysis and statistical analysis.
• Adaptable to fast-paced, dynamic work environment with shifting demands
• Ability to operate with high level of independence to investigate and resolve compliance issues, lead projects, plan and implement improvements, and achieve goals.

All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

Information

1. Salary range: $2200 - $2800
2. Working hours: Mon - Fri, 9am - 6pm

Responsibilities:

• Assist in administrative and process on non-conformances for ISO and GMP.
• Liaise with all departments for any ISO and GMP documentation.
• Liaise with departments on any change of documents, corrective & preventive action
• Ensure all documents follow the requirement.
• Liaise with consultant on ISO process, documents and requirement matters.
• Source quotation for any purchase of equipment for ISO and GMP requirement.
• Filing, typing, printing and destruction management, quality support and overall productivity
• Any other ad hoc duties assigned.

Requirements:

• ITE/Diploma/Degree in Business/Administration
• At least 2 years of working experience -
• Proficient in Microsoft Office (Microsoft Word, Excel and Powerpoint)
• Must be meticulous and able to work independently with minimum supervise
• Knowledge in GMP and ISO 9001, ISO 14001, ISO 45001 will be advantageous.

Interested applicants, send in your updated resume by clicking “Apply Now”.

Michelle Koh

EA License No.: 23C1894

EA Personnel No.: R1656105

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.

As an Inspector II you are tasked to assist in customer complaint investigation process and provide quality oversight for the site to ensure that devices manufactured are compliant to ISO 13485, MDSAP, EU MDR, Alcon Standards and Policies, and regulatory requirement.

Responsibilities

• Support complaint investigation via following up on required actions (DHR/logbook/PM review, etc).•Identify improvement opportunities and lead/support the implementation activities to improve performance and efficiency.•Meet quality objectives set by management & comply to Alcon, QMS and Safety requirements.•Complete Complaint investigation report and maintenance of complaint master list, complaint samples, SOP revision and periodic review.•Perform Site's investigation (NCR, SAR, OOS, Complaints, etc) and Site's WI/SOP/Gap Assessment/Impact Assessment.•Work with cross-functional teams to resolve operational quality issues.•Performs any other duties as assigned by Supervisor according to business needs.

What You'll Bring to Alcon

• Min GCE N/O Levels/ Nitec in any engineering field
• Preperably 1-2 years of experience in quality inspection in manufacturing sector
• Open to 1 year contract
• Comfortable to be based at tuas, transport provided from kranji, outram park and boon lay MRT

Why Join Us:

• Opportunity to work with a leading global medical device company.
• Collaborate with a diverse and talented team in a supportive work environment.
• Competitive compensation package and comprehensive benefits.
• Continuous learning and development opportunities.

Global Facilities Quality Senior Program Manager

Description

As a Global Facilities Quality Senior Program Manager, you will work closely with all the major functional organizations within Global Facilities, & with the world-wide site Facilities, Global Quality and other major corporate organizations to drive Quality systems projects/programs from initiation to completion. These projects/programs are critical to the success of Facilities and the overall network.

Your responsibilities will include, but are not limited to, the following:

• Collaborate with Global & Site Facilities team to proactively manage projects/programs, such as Management of Change (MOC), Failure Mode and Effect Analysis (FMEA), Calibration, Effective Problem Solving (EPS), Global Deviation Management System (GDMS), Risk-Based Thinking (RBT) Risk & Opportunity (R&O) depository, etc. to enhance “Manage Facilities” Quality Management System (QMS) Business Process (BP).
• Creating, leading, driving & maintaining Projects/Programs, including project definition, work breakdown structures, schedules, communication plans, scope documents, and stakeholder analysis; organizing and coordinating project meetings; developing meeting presentations, agendas, minutes, tracking and following up on action items and early identification and resolution of project risks, establishing of metrics, training, software and measuring and monitoring of program status.
• Supporting the Global Facilities Quality Core Team meetings to drive alignment and continuous improvement to support Manage Facilities QMS BP. This includes:Creating and monitoring metrics to measure, monitor and drive continuous improvement of the BP.
  Maintenance of Central Governance repository platform to support Manage Facilities QMS process and all Quality roadmap
  Implementation of critical new business processes that support continuous manufacturing improvement
  Participating and leading Business Process improvement projects on Reliability and Cost projects/programs which contributes directly to Effectiveness & Efficiency KPIs. This includes the implementation of project management within Facilities organization.
  Managing external audits including setup, coordination and successful follow up with the Global Facilities organization. This includes the identification and implementation of QMS processes and tools to enable continued success with customers.
  Enhancing and driving a proactive process based on internal audit program and tracking and supporting any NC follow up through close out. And incorporating lessons learned to continually improve the QMO business processes.
  Managing the communications and access to information from the QMS program and projects through various tools and approaches such as SharePoint web pages, reports and other means
  
• Supporting Global Fac Work-Force Development (WFD) to establish and maintain Global Fac training plans, training assignment, Training Needs Analysis (TNA), establishing to Learning Items, quizzes, and tracking of assigned training status across Global Fac network. Supporting Global Fac Documentation to maintain Global Fac Controlled Document Library, including enforcing documentation control, publishing of ECNs notifications, & conducting Periodic Document Review (PDR).

Qualifications

The successful candidate for this position will have:

• Excellent skills for leading or facilitating multi-organizational teams to success on complex multidimensional projects/programs
• Excellent communication skills to build teams comprised of key skills, to drive progress to plan and to get management support and buy-in for complex projects/programs
• Ability to develop and maintain positive, cooperative, team-oriented relationships with peers, coworkers, management, customers, and auditors
• 2 or more years of Facilities Semiconductor industry engineering experience
• Skills in the creation and management of projects/programs (TABLEAU reports, Sharepoint Online (SPMO), etc)
• Working knowledge and drive quality programs such as MOC, FMEA, Calibration, GDMS, Error-Proofing, etc

Senior Quality Management Systems EngineerEducation

• Bachelor’s degree in engineering or equivalent
• Project/Program management experiences are preferable
• ISO or IATF Audit experience including training and certification are preferable

Workplace

• Travel Required : Yes – Domestic and International travel as required by business needs
• Environment : Office
• Shift : Normal shift (8+ hour)
• GJS : E2 to E3, or P2 to P3

Leads people who are responsible for internal business projects and programs involving department or cross-functional teams of subject matter experts, delivering products through the design process to completion. Plans and directs schedules as well as project budgets. Monitors the project from inception through delivery. May engage and oversee the work of external vendors. Assigns, directs and monitors system analysis and program staff. These positions' primary focus is project/program management, rather than the application of expertise in a specialized functional field of knowledge although they may have technical team members.

Job Responsibilities:

• Support and maintain existing work flow
• Documentation Control
• Inspection of manufactured components
• Communicate with other Departments

Job Requirements:

• working experience
• good initiative and proactive
• Microsoft office

Training and Guidance will be provided.

We are in the Precision Engineering Industry.

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

Job Summary:

• We are seeking a talented Senior Design Quality Engineer (DQE) to lead quality initiatives for our thermal cooling solutions within the electronics and computing industry. The ideal candidate will be responsible for ensuring design and process quality while driving continuous improvements to achieve product excellence. If you are passionate about quality control, process optimization, and collaborating across functions, we encourage you to apply.

Key Responsibilities:

• Implement advanced monitoring systems to enhance product quality and yield. Identify areas for improvement and lead initiatives to optimize production processes.
• Take charge of addressing and improving abnormal quality issues in manufacturing processes. Collaborate with cross-functional teams to implement effective solutions and preventive measures.
• Strengthen internal quality control processes and improve overall capabilities, particularly in mechanical processes such as metal stamping, forging, brazing, die casting, CNC machining, and milling. Drive initiatives aimed at maximizing operational efficiency.
• Lead corrective actions for customer-reported quality issues and communicate preventive solutions to relevant stakeholders.
• Streamline quality inspection planning by integrating automation and advanced technologies whenever possible.
• Promote effective communication and coordination with design, production, and other teams to ensure adherence to quality standards.
• Manage task assignments, performance, and development of the quality team, ensuring timely completion of deliverables.

Requirements:

• Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Quality Engineering, or a related field.
• Minimum of 5-7 years of experience in quality engineering, particularly in manufacturing and design quality.
• Proven experience in mechanical processes, including metal stamping, forging, brazing, die casting, CNC machining, milling, and knowledge of tooling and the design/manufacture of fixtures and jigs.
• Strong analytical, problem-solving, and leadership abilities.
• Familiarity with quality management systems and standards.
• Six Sigma certification or equivalent is a plus.
• Willingness to travel frequently and work abroad in China and Vietnam for at least 10 months per year (includes four round-trip tickets to Singapore annually and separate arrangements for living accommodations).

1. Lead and support QC team for daily QC activities by ensuring timely analysis, documentation, and review of RM/PM/FP/IPC/Stability and Process validation samples as per predefined standards.
2. Write and / or review controlled documentation related to laboratory operations or testing such as SOP's, analytical protocols, analysis reports, forms and validation documents.
3. Ensure compliance with FDA/USP/EP/ICH/ChP regulations and internal controlled procedures in the QC Laboratory.
4. Ensure readiness of QC Laboratory in internal / external audits.
5. Maintain data integrity in Quality Control activities and ensure appropriate traceability.
6. Initiate change control documents.
7. Lead and participate in stability program, method validations, technical transfer, method transfer and validation / qualification activities at the site.
8. Participate in New Product Introduction activities.
9. Lead and participate in laboratory investigations. Document laboratory investigation activities or review and approve laboratory investigation reports.
10. Participate in site corrective action / preventive action (CAPA) program. Ensure timely completion of all commitments made under QMS.
11. Lead and participate in key performance indicators for improving laboratory efficiency, monitoring equipment performance.
12. Lead QC Department training program by imparting training to new staff and comply with Analyst Qualification procedure.
13. Escalate the quality events, trends as appropriate to QC Head.
14. Remain abreast of current regulatory, pharmacopeia and cGMP trends.
15. Serve as subject matter expert on laboratory instrumentation and compliance issues.
16. Lead the QC team, evaluate competencies, assign responsibilities, monitor performance, counsel and provide guidance. Plan & monitor the training and development requirements, motivate staff appropriately to build a committed, motivated & competent team.
17. Participate in personnel decisions (interviewing, hiring, performance appraisals, promotions, termination, staff development, improvement plans) regarding subordinate staff.
18. Maintains a safe laboratory environment by implementing recommendations made by EHS.
19. Initiate CAPEX for equipment purchases.
20. Support in budget preparation for QC Laboratory.
21. Any other activities as and when assigned by the Superior.

EDUCATION:

Degree in science or related discipline (e.g. Chemistry, Chemical Engineering).

EXPERIENCE:

Minimum 8 years of quality control experience in pharmaceutical manufacturing industry and minimum 2 years of supervisory experience in managing team.

KNOWLEDGE & SKILLS:

1. Possess working knowledge of GMP in the pharmaceutical industry.
2. Excellent interpersonal and analytical skills, good verbal, and written communication skills.
3. Working knowledge of qualification, calibration and operation of laboratory equipment such as HPLC, GC, FTIR and Dissolution equipment.
4. Working knowledge of method development, validation, verification of analytical method.
5. Familiarity of 21 CFR Part 11 requirements.