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

- 1 year renewable contract

- Up to 3,000 + PB

- Monday to Friday: 9am – 6.30pm

- Novena

Responsibilities:

• Deliver Quality Assurance objectives by conducting regular call reviews and highlight any potential risk to management.
• Review 15 of closed sales calls per day for General Insurance Team.
• Backup for Auto Insurance for Call Review purposes.
• Promptly report any calls detected with potential quality issues (e.g. misrepresentation, fraudulent) to Management.
• Prepare, track and send Quality Assurance related reports to UOB management and team. (NMD, Service Quality Monthly, Penalty Points Table)
• Keep track on all the status of Quality Assurance Cases from beginning to end process and provide update to management on a timely manner.
• Weekly meeting with management to discuss on discrepancies and solutions for further improvements.
• Other ad-hoc duties as assigned by supervisor

Period:

• 1 Year Renewable Contract

Location:

• Novena

Working Hours:

• Monday – Friday (9.00am – 6.30pm)

Salary:

• Up to 3,000 + PB

Requirements:

• Good to have BCP and PGI Certificates.
• Preferably have quality assurance experience and insurance products knowledge.
• Meticulous and responsible team player.
• Proficient in Microsoft Office.
• Able to multi-task.
• Fast Learner and willing to learn on multiple Insurance Products.

Interested applicants, kindly email your detailed resume (MS Word format is preferred):

[email protected] (Reg No: R1549023)

Please ensure that applications sent through email are no bigger than 1Mb.

We thank all applicants for your interest but regret to inform that only shortlisted candidates would be notified.

Success Resource Centre Pte Ltd (EA License Number: 04C3201)
160 Robinson Road, #13-07/08/09 SBF Center, Singapore 068914

T: 6337 3183 | W: www.successhrc.com.sg

Regulatory Affairs and Quality Assurance Intern

We're seeking a detail-oriented and organized individual to support our Regulatory Affairs and Quality Assurance (RAQA) team.

We are looking for an intern who can begin in May/Jun 2025, and can commit for at least 4 months.

Key Responsibilities

- Maintain and update regulatory documentation and records for submissions

- Ensure regulatory databases are current and compliant with regulatory requirements

- Compile and maintain post-market vigilance documentation

- Assist in CAPA investigations for customer complaints, non-compliance, and audit findings

- Implement corrective actions as needed

- Maintain QMS documentation and records

- Provide support for ad-hoc tasks and projects

Ideal Candidate

- Open to uni undergrad students from all faculties

- Strong interest in regulatory affairs and quality assurance

- Ability to work in a detail-oriented and organized manner

If you're eager to learn and contribute to our RAQA team, we encourage you to apply!

Roles & Responsibilities

The RAQA Manager is responsible for overseeing regulatory compliance and quality affair functions within the organization. The RAQA Manager will work closely with the Head of RAQA and cross- functionally with teams including R&D, Product Development and Operations teams to ensure regulatory requirements and regulatory strategies are effectively implemented and quality systems are maintained and improved.

Key Responsibilities:

(a) Prepare good quality technical documentation.

(b) Manage regulatory submissions for pre-market product registration, renewals, and amendments to ensure timely market entry and compliance.

(c) Stay up to date on evolving regulations and guidelines and provide guidance to internal teams on regulatory landscape.

(d) Monitor post- market surveillance and timely reporting to regulatory authorities.

(e) Prepare and support internal audits, regulatory inspections and audits by notified body, regulatory agencies, partners, and addressing any findings or non- compliance issues that arise.

(f) Support supplier management and audits.

(g) Manage and maintain the effectiveness of Quality Management System (ISO 13485).

(h) Develop, implement and maintain SOPs and quality processes.

(i) Provide training to employees on regulatory and quality requirements.

(j) Responsible for database, processes and systems within RAQA.

Qualifications and Competency

(a) At least Bachelor’s degree in Life Sciences, Biomedical Engineering or a related field.

(b) At least 5 years of professional experience in regulatory affairs and quality affairs in medical device industry.

(c) In-depth knowledge of global regulatory frameworks (US FDA, EU MDR, TGA, SG HSA etc)

(d) Strong knowledge and understanding of ISO 13485, GMP, regulatory and quality standards

(e) Excellent project management, organizational and problem solving skills

(f) Strong attention to details with the ability to manage multiple priorities and deadlines.

(g) Excellent written and verbal communication skills

(h) Proficient in Microsoft Office

(i) Background in medical device manufacturing would be an added advantage.

TikTok is the leading destination for short-form mobile video. At TikTok, our mission is to inspire creativity and bring joy. TikTok's global headquarters are in Los Angeles and Singapore, and its offices include New York, London, Dublin, Paris, Berlin, Dubai, Jakarta, Seoul, and Tokyo.

Why Join Us

Creation is the core of TikTok's purpose. Our platform is built to help imagination thrive. This is doubly true of the teams that make TikTok possible.

Together, we inspire creativity and bring joy - a mission we all believe in and aim towards achieving every day.

To us, every challenge, no matter how difficult, is an opportunity; to learn, to innovate, and to grow as one team. Status quo? Never. Courage? Always.

At TikTok, we create together and grow together. That's how we drive impact - for ourselves, our company, and the communities we serve.

Join us.

Team Intro

The TikTok Live QA team has been focusing on the high quality and the best user experience of TikTok Live products. Our team uses advanced autotesting tools and comprehensive quality assurance methods to continuously control the delivery of products. We are looking for passionate Quality Assurance engineers to join this fast growing industry.

Responsibilities:

1. Responsible for the quality assurance of ByteDance's live-streaming products;

2. Deeply involved in the product development process, coordinate with various roles to continuously deliver products with high quality;

3. Improve product quality and efficiency through technical means such as tool platform development, automated testing and performance testing;

4. Prospective technology research and application, applying appropriate technology to improve business quality.

Qualifications

Minimum Qualifications:

1. BS degree in Computer Science or equivalent majors, with at least one year of native or backend quality assurance experience;

2. Good computer foundation, master at least one of the programming languages: Python,Java,Go,PHP;

3. Abilities to design and execute complete testing plans for complex projects;

Preferred Qualifications:

1. Master Degree in Computer Science or equivalent majors

2. Good logical thinking and team communication skills;

3. Having systematic work experience in automated testing, performance testing, and quality system construction is preferred.

TikTok is committed to creating an inclusive space where employees are valued for their skills, experiences, and unique perspectives. Our platform connects people from across the globe and so does our workplace. At TikTok, our mission is to inspire creativity and bring joy. To achieve that goal, we are committed to celebrating our diverse voices and to creating an environment that reflects the many communities we reach. We are passionate about this and hope you are too.

Key Highlights

• Contract Duration: 6 months
• Nearest MRT: Stadium
• Salary: $3,500 - $5,000 per month
• Working Arrangement: Monday – Friday (Office Hours)

Responsibilities

• Review and improve the ISO (International Organization for Standardization) documentation for preparation of internal and external audits. Validate that all documents are updated and recorded as per requirements
• Validate documents compliance and document findings
• Oversee the review and digitalisation of ISO forms
• Conduct review of improvements on Workplace Safety & Health (WSH) incidents and recommend improvements
• Review risk assessment plans to comply with the WSH Act
• Prepare PowerPoint on sharing and learning on safety for stakeholders
• Collate data and conduct trend analysis on incident and summons/warning letters etc
• Introduce, review, and revise quality standards and specifications for safe operations, focusing on regulatory requirements for fire safety, water rides safety, and water quality
• Validate that the venues, programmes and major events comply with regulatory standards and safety policies
• Organise training needs analysis and recommend safety trainings for staff and stakeholders
• Coordinate Occupational Health & Safety (OHS) Committee and Senior Management meetings
• Implement work improvement teams in the organization
• Coordinate safety initiatives and campaigns
• Manage data collection and analysis for safety initiatives and quality assurance projects

Requirements

• Diploma and/or Degree in any field.
• Experience in safety management, sports, project management and/or event organization will be advantageous.
• Registered MOM Workplace Safety and Health Officer, SCDF Fire Safety Manager, or BCA Ride Manager, with strong expertise in local safety regulations, risk management, and investigation processes will be preferred.
• Able to communicate in a clear and confident manner, written and verbal.
• Strong team player.

Interested candidates please click "Apply Now". We regret to inform you that only shortlisted candidates will be contacted for further discussion.

Wong Xue Ying

BGC Group Pte Ltd

EA License No: 05C3053

Registration No. R22108799

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

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

Key Points:

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

Responsibilities:

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

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

Requirements:

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

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

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

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

Job Responsibilities:

• Support daily Quality Assurance activities, ensuring compliance with approved SOPs and policies in a multi-product, contract manufacturing facility.
• Provide quality oversight (participate GEMBA walk, GMP walk)
• Apply a solid understanding of cGxPs in a GxP setting, performing tasks with minimal supervision.
• Revise, review, and approve SOPs, protocols, reports, and records to ensure accuracy and compliance.
• Make real-time decisions on process events based on knowledge of SOPs and policies.
• Promote collaboration within teams to achieve objectives, demonstrating strong interpersonal skills.
• Perform other tasks as assigned by the supervisor to support the Quality Assurance department.
• Perform IQ and OQ. Involve in URS, design specifications

Requirements:

• Min Diploma/Degree in science related
• Knowledge of regulatory requirements and GMP quality systems.
• Experience in Quality Assurance in any industry

Interested candidates, do submit your resume to [email protected]

Attn: Ariel Fong Jea Yee (Outsourcing Team)
Audrey Chan Yu Jing (R1104782)

Recruit Express Pte Ltd (99C4599)

EA License No: 99C4599

EA Personnel No: R1761665

• 5 days work week
• Location: North

Job Scope:

• Take charge of our Integrated Management System, ensuring processes are documented, owned, and regularly improved.
• Lead internal audits by preparing schedules, conducting audits, reporting findings, and implementing corrective actions.
• Investigate non-conformances, pinpoint root causes, and implement effective solutions to enhance operational quality.
• Oversee compliance with QHSE standards, ensuring alignment with industry and customer requirements.
• Manage document control systems, keeping records accurate, up-to-date, and aligned with regulatory needs.
• Conduct internal training to ensure the team stays ahead in aviation-related standards and practices.
• Collaborate with cross-functional teams to monitor and report quality metrics, driving data-driven decisions.
• Lead quality investigations, identify improvement opportunities, and escalate key findings to management.

Job Requirement:

• A Diploma/Degree in Engineering, preferably in Quality Engineering.
• At least 2 years of hands-on Quality Assurance experience in the aviation industry.
• Proficiency with ISO standards (ISO 9001, ISO 14001, TS 16949) and statistical tools.
• Strong analytical mindset with excellent problem-solving and communication skills.
• Internal/Lead Auditor certification (preferred) and a passion for knowledge-sharing (Train-the-Trainer qualification is a bonus).

To Apply, kindly click on the "APPLY NOW" button

We regret that only shortlisted candidates will be notified.

Staffking Pte Ltd (20C0358) | Chong Kar Ming (John) (R21101412)

Responsibilities

Quality Assurance:

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

Regulatory Affairs:

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

Minimum Skills and Requirements

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

Advantageous Skills

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

• Drive quality culture and promote GMP compliance behaviors to the site.
• Ensure site compliance to Quality Standards (QS) and ICH guidelines.
• Provide QA oversight to the site GMP operations to ensure products produced in compliance with the Quality Standards (PQS).
• Collaborate with cross functional teams to improve quality systems.
• Understand regulatory expectations and support site inspection readiness.
• Work with supply chain and drug product sites to ensure timely delivery of quality products.
• Work with GCMC to file products and address regulatory queries in an accurate and timely manner.
• Require working on rotating shift.

For interested candidates, please send your updated resume:

Email: [email protected]

Whatsapp: 96503173

Telegram: @jesswongie

Jessie Wong Yuan Si

R2197171

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 99C4599

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

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

Purpose:

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

Key Responsibilities:

Supplier Management

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

Executive 1: Minor deviations and CAPA

Executive 2: Minor, major deviations and CAPA

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

QA Raw Material Release and Warehouse oversight

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

Decision Making:

Proposals & Recommendations

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

Skills:

Professional

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

Technical

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

Business

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

Competencies:

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

Where will I be based?

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

Job Description

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

Key Responsibilities

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

APPLY NOW!!!

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

Kindly apply through ANY of the following methods:

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

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

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

About Us

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

About The Role

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

Your responsibilities shall include the following:

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

Your Qualifications & Experience

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

Contact

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

Job Scope

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

Requirements

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

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

Alex Goh Hock Leong (R1763413)

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

Job Responsibilities:

• Assist and support the SEA Quality and HSE Manager in implementing and maintaining Quality, Health, Safety, and Environment systems in Singapore and Australia.
• Ensure compliance with ISO standards and other relevant certifications, supporting auditing processes in both locations.
• Investigate incidents and product non-conformities, promoting the company's incident reporting and management system.
• Control system documentation and procedures for Southeast Asia, including Australia, ensuring consistency with established standards.
• Conduct quality checks and inspections on manufacturing and installation processes for current product range.
• Participate in HSE committee meetings and implement HSE procedures to achieve required safety standards.
• Chair monthly Quality Improvement Programme (QIP) meetings and monitor proper notification filing by SAP users.
• Submit monthly quality reports, including Voice of Customer data, notification workflow, and cost impact analyses.
• Provide training and mentoring to team members on quality assurance systems and procedures.
• Support and maintain Quality and HSE management systems, recommending improvements when necessary.

Job Requirements:

• Qualification in Engineering, Safety, Quality or equivalent
• Minimum 2 years of QA/QC experience in steelwork/machinery manufacturing and HSE management in industrial/manufacturing environments, with construction industry experience preferred
• Proven engagement and consultative skills

Interested candidates please send in your updated resume to Tan Shui Li, Katharine (Chen Ruili)(R1660568) - [email protected]. Please not that only shortlisted candidates will be notified. Thank you for your kind understanding.

DESCRIPTION

This is an exciting opportunity for you to be an integral part of the Quality Management department to optimise patient care and outcome.

The Administrative Executive is responsible for providing administrative support to ensure the smooth and efficient functioning of the department initiatives within the hospital. This role involves the coordination and maintenance of accurate records, meetings, and supporting the implementation of quality management projects.

RESPONSIBILITIES

Documentation Management:

• Maintain accurate and up-to-date records related to quality management.
• Organize and file documentation in compliance with regulatory standards.

Data Entry and Analysis Support:

• Assist in data entry for quality metrics and performance indicators.
• Generate basic reports and assist in data analysis under senior staff guidance.

Meeting Coordination:

• Schedule and coordinate meetings for the Quality Management team.
• Prepare meeting agendas and distribute relevant materials.

Communication and Correspondence:

• Facilitate communication between internal and external stakeholders including team members, other departments, external healthcare institutions, among others.
• Draft routine correspondence and respond to inquiries as directed.

Assist in Quality Projects:

• Support the implementation of quality management projects.
• Collaborate with team members to ensure project timelines and deliverables are met.

QUALIFICATIONS/REQUIREMENTS

• Minimum Diploma.
• At least 2 years working experience.
• Good speaking and writing skills
• Proficient in computer skills including Microsoft Office (e.g. Excel, Words etc.)
• Self-disciplined, motivated, self-starter, Meticulous
• Ability to work collaboratively in a team environment

Interested candidates, please apply with your updated resume, expected salary and notice period.

We regret that only shortlisted applicants will be notified.

NOTE: CRAWFURD HOSPITAL IS NOT IN COLLABORATION WITH ANY EMPLOYMENT AGENCY NOR CONSULTANT FOR OUR POSITIONS OPENING.

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 a Quality System Associate, you will be responsible for the customer complaint handling/ management/ 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.

In this role, a typical day will include:

• Trend, analyse and monitor key performance indicators, suggest improvements, and escalate to supervisor/management as necessary.
• 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.
• Participate as site representative in the Vision Care Complaints community at Global Corporate Platform.
• Lead/Host the site Customer Complaint Review Board (CCRB) meeting in the discussion on complaint investigations and evaluation of complaints trend.
• Support internal and external audits and is responsible for audit finding closure, as required.
• Work with cross-functional teams to resolve operational quality issues.
• Perform Monthly Technical Complaint Periodic trending (all platforms).
• Performs any other duties as assigned by Supervisor according to business needs

WHAT YOU’LL BRING TO ALCON:

• Bachelor’s in science/engineering
• 1-3 years work experience in quality field, experience in GMP environment will be highly advantageous
• Training will be provided for those without experience

HOW YOU CAN THRIVE AT ALCON:

· Good team player

· Enjoy working with various cross functional team across manufacturing site

Alcon Careers

See your impact at alcon.com/careers

Responsibilities:

• Inspect factory equipment for cleanliness prior to production.
• Perform comprehensive checks on raw materials and finished products for quality, including microbial, sensory, and visual evaluations.
• Immediately report any quality concerns to supervisors for investigation and resolution.
• Coordinate with other departments to schedule material inspections and sampling.
• Verify certificates to ensure raw materials meet required standards before use.
• Provide training for new staff members.
• Assist with both internal and external audits.
• Maintain precise and accurate records.
• Calibrate equipment as necessary.
• Manage inventory and ensure lab cleanliness.
• Issue Certificates of Analysis for materials and finished products.
• To perform any additional tasks assigned by the company.

Requirements:

• Minimum 2 years of relevant working experience in related field.
• Proficient in Microsoft Word, Excel, and PowerPoint.
• Able to work independently, as well as a team player.
• Possess good communication skills – written and verbal

To facilitate in the job application, please include the following in the resume:-

• Last drawn, current and expected salary.
• Duties and responsibilities for each job.
• Resume in Microsoft Word format
• Reason for leaving for past and present employment.
• Availability.
• Residential area.

Thank you.

David Ong (R1110279)

Adept Manpower (EA License: 22C1006)

https://adeptmanpower.com/

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

Job Responsibilities:

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

Job Requirements:

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

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

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

We regret that only shortlisted candidates will be contacted.

LIONG ZHAO GUAN (R22107632)

EA Recruitment Pte Ltd

EA License No: 21C0492

• Well Established Medical Devices Manufacturing Company
• Basic $2200 - $3000 + Allowance + AWS + Variable Bonus
• Excellent Welfare and Benefits + Career progression
• Working location: Boon Lay
• Working hours: 12 Hours Shift

Job Responsibilities:

• Carry out inspection of incoming materials and finished products according to operational instructions to ensure that materials or products meet the requirements
• Ensure product identification is correct and stored in the correct location, maintenance of inspection equipment and daily monitoring of production environment
• Statistics on the quality status of incoming materials and processes and the quality of shipped products
• Report abnormalities to superior in timely manner and inform relevant departments and track the improvement status of non-conformities
• Assist in customer complaint analysis and take corresponding improvement measures
• Ensure records comply with good writing practice GDP requirements
• Assist the superior to complete other tasks

Job Requirements:

• At least 1 year of quality management experience and basic computer software
• Blueprint reading capabilities, and ability to use measuring devices like gauges, meters, calipers
• Documentation and reporting skills

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.

NG JYA YEE (R23119014)

EA Recruitment Pte Ltd

EA License No: 21C0492

• Well Established Medical Devices Manufacturing Company
• Basic $2200 - $3000 + Allowance + AWS + Variable Bonus
• Excellent Welfare and Benefits + Career progression
• Working location: Boon Lay
• Working hours: 12 Hours Shift

Job Responsibilities:

• Carry out inspection of incoming materials and finished products according to operational instructions to ensure that materials or products meet the requirements
• Ensure product identification is correct and stored in the correct location, maintenance of inspection equipment and daily monitoring of production environment
• Statistics on the quality status of incoming materials and processes and the quality of shipped products
• Report abnormalities to superior in timely manner and inform relevant departments and track the improvement status of non-conformities
• Assist in customer complaint analysis and take corresponding improvement measures
• Ensure records comply with good writing practice GDP requirements
• Assist the superior to complete other tasks

Job Requirements:

• At least 1 year of quality management experience and basic computer software
• Blueprint reading capabilities, and ability to use measuring devices like gauges, meters, calipers
• Documentation and reporting skills

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

RESPONSIBILITIES:

• Develop and update the quality material database and ensure proper recording and documentation
• Ensure proper documentation of raw materials/ ingredients/ finished products & traceability in place
• Liaise with regulators on mandatory requirements and compliance related matters
• To provide internal and external customers with technical advice and/or documentation when required
• Assist in the maintenance of HACCP and BRCGS management system

REQUIREMENTS:

• Diploma / Bachelor's Degree in Food Science or related field.
• Good knowledge of Quality Management System (HACCP, BRC, ISO 22000)
• Good communication, Organizational and Analytical Skills
• Able to work in a team and independently

The summary of the scope of activity as below:

1. Revise and review SOPs

2. Review executed MBR/EBR

3. Support manufacturing team with any quality interpretation , queries and issues.

4. Provide quality oversight (participate GEMBA walk, GMP walk)

5. Perform archival of QO documents

6. Perform IQ and OQ. Involve in URS, design specifications

Requirements

• Min Degree in science / engineering related courses
• Min 2 to 3 exp of Quality experience from pharma / Medical industry
• Able to start work immediately

Up to $8K (For Senior role) x 1

Up to $6K (For junior role) x 1

Pharma MNC

Interested candidates, please forward your resume to [email protected]

Consultant: Huang Jingsheng Kevyn (R1333338)

Recruit Express Pte Ltd (99C4599)

As an intern for the Assurance, your responsibilities include:

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

Requirments:

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