Total 551 it specialist job vacancies in Quality Assurance / Control category in Singapore

Our client is in Scientific and Medical industry. Due to their current expansion plan, they are looking for a Service Engineer to join their Engineering Team, in hopes of developing the current high performing team. They are located in the Central area – easily accessible.

Duties of Regulatory Compliance Specialist:

• Ensure compliance with regulatory standards for medical devices and biotechnology products, preparing and submitting necessary documentation.
• Assist in product registration, renewal, and change submissions, liaising with regulatory agencies and suppliers.
• Develop regulatory strategies and provide guidance during product development for timely market access.
• Maintain accurate regulatory documentation and records for submissions and approvals.
• Support Quality Assurance to ensure regulatory compliance and participate in audits when needed.
• Collaborate with internal teams to integrate regulatory requirements into product launches and provide regulatory training.
• Identify regulatory risks and develop mitigation strategies for product marketing and commercialization.
• Monitor post-market safety data, reporting adverse events as required by authorities.

Requirements:

• Degree in Life Science or related field
• Relevant experience

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

We regret that only shortlisted candidate will be notified

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

• MNC Company
• Basic $2500 - $3200 + Allowance + AWS + VB + Excellent Benefits
• Excellent Welfare and Benefits + Career progression
• Working days: Monday to Friday
• Working hours: 8.30am to 5.15pm
• Jurong Island. Company Transport provided
• Training provided for those without/lesser experience

Job Responsibilities:

• To perform routine analysis of polymer testing & wet chemistry analysis
• To ensure that tests assigned are performed in a timely manner in accordance with validated test protocols and procedures
• To perform instruments’ calibrations, maintenance, and troubleshooting
• To perform housekeeping and maintain the cleanliness in the laboratory
• To perform inventory check & improvement idea in the lab
• To assist superiors with non – routine study samples and any other tasks assigned

Requirements:

• Diploma in Chemical Process Technology / Chemical Engineering
• Willing to work overtime when required

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.

THIEN CHING MEI (R2198032)

EA Recruitment Pte Ltd

EA License No: 21C0492

1. Perform analysis and tests of drug products, raw materials, in-process materials, release test samples, stability samples, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance with established specifications.
2. Preparation of reagents/diluents/ dissolution media as per STP.
3. Perform a various qualitative tests or qualitative assays on samples using modern and automated instrumentation.
4. Utilize electronic laboratory information systems such as LIMS for acquisition and processing of analytical data.
5. Ensure implementation of SOP for all corresponding activities.
6. Write controlled documentation related to QC Laboratory operations or testing such as SOP's, analytical protocols, analysis reports and forms.
7. Ensure real time documentation, maintain data integrity and appropriate traceability.
8. Assist in maintenance and calibration of test instruments per specifications.
9. Responsible for the accurate, timely and compliant execution of assigned projects, analytical testing and related documentation.
10. Responsible for checking all results in LIMS/RDS and reporting of any observed results that do not meet the requirement (OOS/OOT/Deviation) for further investigation.
11. Destruction of expired finished products/ raw material samples as per SOP and recording the same in the register.
12. Responsible for QC lab and equipment/instrument cleanliness.
13. Responsible for procuring and receipt of QC lab glassware and consumables.
14. Any other activities as and when assigned by the Superior.

Job Responsibilities

• Able to lead project for Method validation/verification/transfer to introduce new/remediated QC methods for testing existing and new products independently
• Subject matter expert in method validation, verification and transfer; covering wide arrays of methods and complex techniques
• Maintain validated status of assays by establishing a control and monitoring strategy to ensure that the method is in the state of control, and the data generated from the method is reliable.
• Author of equipment qualification documents as indicated in global procedures
• Control Trend establishment and investigations

Job Requirements

• Degree in Chemistry, Biochemistry, Biotechnology or Diploma in Chemistry, Biochemistry, Biotechnology
• Team player and independent contributor
• Basic assay verification/validation know-how
• Project Management Skills

If you are interested in any of the positions, do kindly drop your most updated resume to [email protected]

Esther Lim Suk Hui

EA Personnel No: R18728082

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 99C4599

LIMS QC Specialist (Pharmaceutical/ GxP/ 21 CFR Part 11)

9 Months Contract

Location: Tuas

Up to $7,000 depending on experience

Industry: Pharmaceutical

Responsibilities:

• Implementation of LIMS (Laboratory Information Management System) in QC, alongside with the following activities:

1. Master Data Collection
2. Write and execute LIMS IQ (Installation Qualification) Test Cases
3. Write and execute LIMS UAT (User Acceptance Test)
4. Write LIMS-related SOPs, including update/ revision.
5. Conduct end user training.

• Support the implementation and maintenance of other QC GxP Systems.
• Provide user administration support to laboratory system, support user requests including troubleshooting and problem solving.
• Write and execute QC application software validation test scripts.

Requirements:

• Bachelor’s or Master’s Degree in Pharmaceutical Sciences, related life Sciences or IT/ Technology with minimally 3-5 years of experience in QC Systems
• Good understanding of 21 CFR Part 11 and data integrity requirements
• Familiar with LIMS set-up and data structure
• Experience in writing and executing QC Systems test scripts
• Excellent interpersonal relationships and good communication skills to establish the partnerships with key stakeholders.

Lim Pey Chyi - [email protected]

Recruitment Consultant (R2090579)

Manpower Staffing Services (S) Pte Ltd

EA Licence: 02C3423

Responsibilities:

• Provide regulatory advice and support for compliance and technical requests in the region.
• Build relationships with governments, associations, local distributors, and third-party manufacturers to ensure compliance and approvals.
• Guide the supply chain on regulatory impacts of third-party warehouse activities and manage related documents.
• Support manufacturers in the region and review labels and safety data sheets for compliance.
• Coordinate and support product registration activities, and report these activities to stakeholders and the Global Regulatory Affairs Manager weekly.
• Assist with business development queries and explore business relationships for R&D projects.
• Train new staff on regulatory constraints and challenges.
• Implement new technologies and innovations relevant to company and customer needs, including regulatory processes and databases.
• Ad hoc duties as assigned.

Requirements

• Degree in Business Administration, Supply Chain Management, or equivalent
• At least 4 - 6 years of regulatory affairs/ compliance experience, preferably from chemical-related industry
• Good knowledge of legal requirements and procedures

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

EA License No: 13C6305
Reg. No.: R24120209

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

Job Responsibilities:

• Report on QA events related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations
• Assist in generating procedures related to Manufacturing QA functions / activities
• Periodically review records to verify that quality standards for each product is met
• Prepares weekly/monthly reports, prepares metrics and trends data to identify and prioritize continuous improvement opportunities
• Responsible to maintain all testing equipment in compliance, calibration and certification.
• Promptly communicates with Operations regarding complaints, product issues/variances.
• Assists in maintaining compliant controlled substance documentation specifically associated with sample handling and reconciliation
• Enforce compliance with QA processes, Equipment Qualification, and Computer System Validation principles.
• Assist in the development of action plans and implementation schedules, and the verification of completed actions.
• Conduct periodic internal reviews or audits to ensure that compliance procedures are followed.
• Conduct and report the findings of internal investigations of compliance issues.

Job Requirements:

• Degree in Chemistry, Biochemistry, Biotechnology or Diploma in Chemistry, Biochemistry, Biotechnology.
• Demonstrated ability to collaborate with cross functional or cross sites to achieve objectives.

If you are interested in any of the positions, do kindly drop your most updated resume to [email protected]

Esther Lim Suk Hui

EA Personnel No: R18728082

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 99C4599

Job Responsibilities

• Able to lead project for Method validation/verification/transfer to introduce new/remediated QC methods for testing existing and new products independently
• Subject matter expert in method validation, verification and transfer; covering wide arrays of methods and complex techniques
• Maintain validated status of assays by establishing a control and monitoring strategy to ensure that the method is in the state of control, and the data generated from the method is reliable.
• Author of equipment qualification documents as indicated in global procedures
• Control Trend establishment and investigations

Job Requirements

• Degree in Chemistry, Biochemistry, Biotechnology or Diploma in Chemistry, Biochemistry, Biotechnology
• Team player and independent contributor
• Basic assay verification/validation know-how
• Project Management Skills

If you are interested in any of the positions, do kindly drop your most updated resume to [email protected]

Esther Lim Suk Hui

EA Personnel No: R18728082

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 99C4599

Our client is in Scientific and Medical industry. Due to their current expansion plan, they are looking for a Service Engineer to join their Engineering Team, in hopes of developing the current high performing team. They are located in the Central area – easily accessible.

Duties of Regulatory Compliance Specialist:

• Ensure compliance with regulatory standards for medical devices and biotechnology products, preparing and submitting necessary documentation.
• Assist in product registration, renewal, and change submissions, liaising with regulatory agencies and suppliers.
• Develop regulatory strategies and provide guidance during product development for timely market access.
• Maintain accurate regulatory documentation and records for submissions and approvals.
• Support Quality Assurance to ensure regulatory compliance and participate in audits when needed.
• Collaborate with internal teams to integrate regulatory requirements into product launches and provide regulatory training.
• Identify regulatory risks and develop mitigation strategies for product marketing and commercialization.
• Monitor post-market safety data, reporting adverse events as required by authorities.

Requirements:

• Degree in Life Science or related field
• Relevant experience

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

We regret that only shortlisted candidate will be notified

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

• MNC Company
• Basic $2500 - $3200 + Allowance + AWS + VB + Excellent Benefits
• Excellent Welfare and Benefits + Career progression
• Working days: Monday to Friday
• Working hours: 8.30am to 5.15pm
• Jurong Island. Company Transport provided
• Training provided for those without/lesser experience

Job Responsibilities:

• To perform routine analysis of polymer testing & wet chemistry analysis
• To ensure that tests assigned are performed in a timely manner in accordance with validated test protocols and procedures
• To perform instruments’ calibrations, maintenance, and troubleshooting
• To perform housekeeping and maintain the cleanliness in the laboratory
• To perform inventory check & improvement idea in the lab
• To assist superiors with non – routine study samples and any other tasks assigned

Requirements:

• Diploma in Chemical Process Technology / Chemical Engineering
• Willing to work overtime when required

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.

THIEN CHING MEI (R2198032)

EA Recruitment Pte Ltd

EA License No: 21C0492

Job Responsibilities

• Able to lead project for Method validation/verification/transfer to introduce new/remediated QC methods for testing existing and new products independently
• Subject matter expert in method validation, verification and transfer; covering wide arrays of methods and complex techniques
• Maintain validated status of assays by establishing a control and monitoring strategy to ensure that the method is in the state of control, and the data generated from the method is reliable.
• Author of equipment qualification documents as indicated in global procedures
• Control Trend establishment and investigations

Job Requirements

• Degree in Chemistry, Biochemistry, Biotechnology or Diploma in Chemistry, Biochemistry, Biotechnology
• Team player and independent contributor
• Basic assay verification/validation know-how
• Project Management Skills

If you are interested in any of the positions, do kindly drop your most updated resume to [email protected]

Esther Lim Suk Hui

EA Personnel No: R18728082

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 99C4599

Job Responsibilities:

• Report on QA events related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations
• Assist in generating procedures related to Manufacturing QA functions / activities
• Periodically review records to verify that quality standards for each product is met
• Prepares weekly/monthly reports, prepares metrics and trends data to identify and prioritize continuous improvement opportunities
• Responsible to maintain all testing equipment in compliance, calibration and certification.
• Promptly communicates with Operations regarding complaints, product issues/variances.
• Assists in maintaining compliant controlled substance documentation specifically associated with sample handling and reconciliation
• Enforce compliance with QA processes, Equipment Qualification, and Computer System Validation principles.
• Assist in the development of action plans and implementation schedules, and the verification of completed actions.
• Conduct periodic internal reviews or audits to ensure that compliance procedures are followed.
• Conduct and report the findings of internal investigations of compliance issues.

Job Requirements:

• Degree in Chemistry, Biochemistry, Biotechnology or Diploma in Chemistry, Biochemistry, Biotechnology.
• Demonstrated ability to collaborate with cross functional or cross sites to achieve objectives.

If you are interested in any of the positions, do kindly drop your most updated resume to [email protected]

Esther Lim Suk Hui

EA Personnel No: R18728082

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 99C4599

Industry: Shipping Services Industry
Location: West
Working Hours: Monday Friday, Office Hours
Good Remuneration Package

Process Management:

• Work with respective departments (Process Owner) to ensure that the overall process for the Company is efficient and effective.
• Manage process documentation flows to ensure that the processes for all departments are fully documented.
• Be the subject matter expert for business systems (AX, Cloud and etc.) and collaborate with IT to work on changes for system improvements
• Be the neutral party in investigating and documenting the root cause of customer complaints and disputes.
• Manage the documentation of customer complaint reports to clearly document the root cause and corresponding improvement plan to address the root cause.
• Follow through and ensure effective implementation of changes to the improvement required by respective departments in solving issue identified
• Be the neutral party in reviewing the issue and solution of improvement areas raised by respective departments in Improvement Potential System
• Lead process re-engineering, to reduce turnaround time for end-to-end processes and improve customer experience.

Quality Assurance:

• Developing, implementing, and maintaining quality management systems based on ISO standards - ISO 9001, ISO 14001, ISO 45001, and ISO 22000.
• Conduct regular audits to identify areas for improvement, non-conformities, and opportunities for enhancing quality processes.
• Stay up-to-date with the latest developments in ISO certifications, as well as industry best practices, and incorporate them into the quality management system.
• Lead the preparation of audits by external certification bodies, ensuring all necessary documentation is in place and readily accessible.
• Represent the company in quality-related matters with external stakeholders, including customers and regulatory bodies.

Requirements:

• Bachelor's degree in a relevant field (Quality Management, Business Management, Business Process Management and etc.); Advanced Diploma or certifications (e.g., Six Sigma, CQE) are a plus.
• Minimum of 3-5 years of experience in business process management and quality control, with primary focus on business process management.
• Strong understanding in business process management aspects.
• Strong understanding of ISO 9001, ISO 14001, ISO 45001 and ISO 22000 Standards, with the ability to interpret and implement their requirements effectively.
• Proven experience in managing quality control, driving continuous improvement initiatives, and fostering a culture of quality excellence.
• Proficiency in quality control methodologies and root cause analysis techniques.
• Familiarity with quality management software and tools.

Please send your updated cv to [email protected]

All Successful candidates can expect a very competitive remuneration package and a comprehensive range of benefits.

We regret that only shortlisted candidates will be notified

EA Personnel: Lim Jing Yee, Lena
EA Registration No.: R1872533

People Profilers Pte Ltd
20 Cecil St, #08-09, PLUS Building, Singapore 049705
EA Licence Number: 02C4944
Tel: 6950 9755

JOBID: QVRY98X6

Healthcare Quality & Regulatory Compliance Specialist (Hybrid) AMEA

Opportunity:

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

Your Contribution:

1. Quality Policies & Procedures: Determine, implement & promote policies and procedures for company 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: Provide inputs to support the design & implementation of robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits.

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

8. Operations & Customer Audit Programs: Lead regular audit programs / random checks 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 support in issue resolution via conducting root cause analysis (depot).

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 and support validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems.

What we look for in you!

1. Hold local pharmacist license (and may be required to hold licenses and permits on behalf of the company)

2. Have three (3) to five (5) years of relevant experience in pharmaceutical or healthcare industry in a quality related role

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

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

Your competencies:

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

[Job ID: 738406]
Responsibilities:

• Assist localization manager in managing the in-house localization QA team and outsource localization vendors to ensure the localization projects are completed on time and on quality.
• Oversee the translation and proofread, edit, and revise texts from Japanese to English (and vice versa) for all assets such as in-game texts, marketing content, news, bug reports, promotions, guides, events, glossary creation, etc., as tasked, to ensure that its quality meets BNE standards.
• Assist localization manager in handling communications with stakeholders both internal and external (mostly in English and Japanese) on a daily basis.
• Keep track of localization project timeline and deliverables from in-house QA team and/or outsource localization/QA vendors under the supervision of localization manager.
• Provide linguistic guidance/instructions/directions to outsource translation/QA vendors to ensure quality of Bandai Namco game localization in SEA region

Requirements:

• 1 years of translation or QA testing or localization experience in the gaming industry or related role in a similar industry
• Business level proficiency in Japanese to fulfill the translation duties
• Proficient in Japanese to liaise with Japanese Headquarter
• Proficient in MS Office
• Excellent time management and multi-tasking skills
• Able to handle multiple projects all at once without compromising quality or timeline
• Ability to take initiative and project lead with attention to detail
• High organizational and problem-solving skills
• Able to assess the situation quickly and report in a timely manner
• Familiarity with localization tools and process will be a plus

We regret that only shortlisted candidates will be notified. However, rest assured that all applications will be updated to our resume bank for future opportunities.

Please kindly refer to the Privacy Policy of Good Job Creations for your reference: https://goodjobcreations.com.sg/en/privacy-policy/

EA Personnel Name: Chay Yoke Ting Vanessa (Xie Ruoting)
EA Personnel Registration Number: R23115805
EA License No.: 07C5771

Our client is in Scientific and Medical industry. Due to their current expansion plan, they are looking for a Service Engineer to join their Engineering Team, in hopes of developing the current high performing team. They are located in the Central area – easily accessible.

Duties of Regulatory Compliance Specialist:

• Ensure compliance with regulatory standards for medical devices and biotechnology products, preparing and submitting necessary documentation.
• Assist in product registration, renewal, and change submissions, liaising with regulatory agencies and suppliers.
• Develop regulatory strategies and provide guidance during product development for timely market access.
• Maintain accurate regulatory documentation and records for submissions and approvals.
• Support Quality Assurance to ensure regulatory compliance and participate in audits when needed.
• Collaborate with internal teams to integrate regulatory requirements into product launches and provide regulatory training.
• Identify regulatory risks and develop mitigation strategies for product marketing and commercialization.
• Monitor post-market safety data, reporting adverse events as required by authorities.

Requirements:

• Degree in Life Science or related field
• Relevant experience

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

We regret that only shortlisted candidate will be notified

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

Primary activities include, but are not limited to:

· Processing of customer complaints received against finished products including handling of returned customer complaint samples.

· Perform Adverse Event investigations and support compilation and analysis of PQC and AE data for Complaint Unit business processes.

· Support Market Action activities including BPDR/FAR submission, Fact Finding, and Recall

· Authoring Annual Product Reviews (APRs).

· Authoring and managing Quality Agreements (QAs) concerning both other Merck Sites and external vendors and/or contractors involved in the GMP aspects of the Site.

· Providing Quality oversight of supplier information across all categories of suppliers that service WP.

· Run queries / reports / metrics in support of business processes

· Update Standard Operating Procedures (SOPs) related to these business processes as needed.

· Participate/support compliance projects to sustain and/or enhance compliance

· Participate/support projects to enhance efficiency and effectiveness

· Support ad-hoc data requests and analysis

· Author, review, and approve procedures and other control documents.

· Assist with aspects of Regulatory Inspections and commitments

· Participate in internal audits and shop floor inspections

· Performing gap analysis and remediation

· Quality Support/ownership for applicable automation systems

· Regulatory surveillance

· Conduct training on compliance topics

· Execute projects as required by the Associate Director

Requirements:

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

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

Thank You.

Leon Leong De Cong
R1551708

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

Essential Functions

· The Quality Assurance Specialist is an adept technical writer/editor and the use of desktop Office applications.

· The QA Specialist must become familiar with site databases and proficient in the retrieval and presentation of information.

· The QA Specialist will trend this information using the graphical features of Microsoft Excel and display these in Microsoft Word reports. A major example is the Annual Product Review (APR).

· In addition the QA Specialist will lead in Change Control decisions and work with other departments to identify and solve issues that impact the product validation or the regulatory state.

· The QA Validation Specialist not only works with all site departments but supports Corporate Regulatory and R&D needs as well.

· The QA Specialist will support Regulatory Affairs with technical writing as pertaining to equipment and processes for product submissions and Request for Information (RFI).

· The QA Specialist will provide project support for the New Product launches and utilize Microsoft Project to organize site deliverables.

· Additional responsibilities may include assisting with validation activities associated with equipment and/or processes.

· The job may require travel to vendor sites to complete Factory Acceptance Testing in order to accept equipment for the site. Expect travel of less than 10%.

Requirements:

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

If you are interested in any of the positions, do kindly drop your most updated resume to l[email protected]

Thank You.

Leon Leong De Cong
R1551708

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

Responsibilities (include but are not limited to):

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

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

· Ensure timely issuance of production records, procedures and labels

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

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

· Communicate lot disposition pending issues to Management

· Ensure approval and timely delivery of Final Product

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

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

· Review and approve Manufacturing Production Records

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

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

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

· Review equipment and facility technical and investigation reports

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

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

· Perform other duties as required

Requirements:

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

If you are interested in any of the positions, do kindly drop your most updated resume to leonleong@recruitexpress.com.sg

Thank You.

Leon Leong De Cong
R1551708

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

As a QA Executive for Amber, you will play a key role in ensuring the overall quality and performance of the product NextGen Management Systems as well as client websites/applications. You will be responsible for designing and executing test plans, troubleshooting issues, and collaborating with cross-functional teams to deliver a seamless and reliable platform for our users. You will ensure that the platform meets high standards of functionality, usability, and security, while continuously striving to enhance the overall user experience.

Key Responsibilities:

• Test Planning & Execution:Develop, document, and execute detailed test plans and test cases based on product requirements.
  Perform manual and automated testing to identify and troubleshoot software defects, ensuring the product meets all quality standards.
  
• Bug Tracking & Reporting:Identify, document, and track software defects using bug-tracking tools.
  Collaborate with developers to communicate issues, provide details for resolution, and verify bug fixes.
  
• Regression & Performance Testing:Conduct regression testing to ensure previous functionality remains intact after new releases or updates.
  Execute performance, load, and stress testing to ensure the platform performs optimally under varying conditions.
  
• Collaboration:Work closely with developers, product managers, and UX/UI teams to understand requirements and participate in sprint planning meetings.
  Provide insights and feedback on user experience, and recommend improvements to enhance product functionality and usability.
  
• Documentation:Create and maintain detailed documentation for test plans, test scripts, and results.
  Prepare and present QA reports to management and stakeholders.
  
• Continuous Improvement:Stay updated on the latest testing methodologies and tools to continuously improve QA processes and tools.
  Identify opportunities for automation to improve efficiency in testing.
  

Qualifications:

• Bachelor’s degree in Computer Science, Information Technology, or a related field.
• 2+ years of experience in Quality Assurance, preferably in software testing or SaaS-based products.
• Strong knowledge of QA methodologies, tools, and processes.
• Experience in manual and automated testing tools such as Selenium, JIRA, or similar.
• Familiarity with Agile and Scrum methodologies.
• Basic understanding of programming languages like Java, Python, or SQL.
• Excellent problem-solving skills and attention to detail.
• Strong communication skills with the ability to work in a fast-paced environment.

Preferred Skills:

• Experience with testing in web applications.
• Familiarity with API testing tools like Postman.
• Knowledge of version control systems like Git.
• Basic understanding of security and compliance testing for web applications.

Job Description:

• Ensure the machine is working correctly, and calibrating the machine to ensure proper measuring.
• Perform incoming, in-process and final inspection as per customer requirement.
• Maintain calibration record of measuring equipment.
• Document inspection results by completing reports and logs.
• Maintain safe and healthy working environment by following standards and procedures.
• Raise non-conformance report if necessary.

Job Requirements:

• NITEC/Higer NITEC in Precision Engineering.
• 2 -3 years of relevant QC experience in a manufacturing environment and knowledge.
• Able to interpret technical/mechanical drawings of geometrical dimensioning and tolerance.
• Able to perform CMM measurement; preferably with Wenzel or Zeiss.

Key Responsibilities:

• Act as an integral member of the Quality Systems team, ensuring effective quality oversight for validation activities with an emphasis on Data Integrity.
• Collaborate with Subject Matter Experts to support the validation team in conducting gap analyses and risk assessments prior to qualification activities, recommending mitigation plans for any identified gaps.
• Participate in investigations of validation discrepancies and assist in reviewing and approving discrepancy reports to support the closure of Corrective and Preventive Actions (CAPA).
• Review and authorize validation documents, including protocols, reports, and related materials.
• Provide guidance on validation-related inquiries and challenges throughout the process.
• Review and approve routine Standard Operating Procedures (SOPs), forms, and other pertinent procedures, including Manufacturing Batch Records.

Qualifications:

• Extensive experience in quality oversight of validation activities, particularly concerning Data Integrity requirements.
• Proficient in conducting gap analyses and risk assessments while proposing effective mitigation strategies.
• Experienced in handling discrepancy investigations and managing CAPA processes.
• Expertise in reviewing and approving validation documents and operational procedures.
• Strong communication and problem-solving abilities, with a focus on compliance and continuous quality improvement.

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

As a Specialist you will be responsible for support and administration (system back-up, user access administration) for LIMS, MODA and other related Laboratory computerized systems. This role also requires to process the LIMS and MODA static data requests

Responsibilities

• Support and administration (system back-up, user access administration) for Sample Manager LIMS, MODA LIMS, iLAB, and other related Laboratory computerized systems
• Maintenance of LIMS static data (Sample Manager LIMS, MODA LIMS and STATISTICA systems)
• Support for installation and qualification/ validation of software related aspects of computerized instrumentation
• Actively contributes to operational efficiency/continuous improvement initiatives.
• Support system audit trail review all related Laboratory computerized systems
• Maintenance of software related changes to computerized instruments
• Server and database maintenance and administration as relates to laboratory systems
• Provide training for the roll-out of new computerized systems.
• Generation and execution of computer validation documentation (protocols and reports)
• Can identify computer related issues; troubleshoot, identify and complete or coordinate deviation, change control and/ or corrective action records.
• System/ equipment manufacturer and or vendor interaction as required in order to trouble shoot system issues.
• Available to troubleshoot and resolve critical system issues as they occur.
• Experience manages projects (people/ team environment) to meet the timelines.
• Customer and regulatory agency interaction as required.
• Oversight of computer system policies and procedure in order to ensure policy is aligned with current regulatory expectations.
• Familiarity with 21 CFR Part 11 and EU Annex 11 requirements, data integrity requirements and expectations as well as common industry practice with respect to laboratory computerized system management and administration.
• SME in 1 or more areas as aligned with training plan.

Experience

• Degree/Diploma in relevant Science field or Equivalent
• Minimum 5 years of experience
• Relevant work experience preferably Lab related IT experience in a biotech or medically related field.
• Experience in lab computer systems essential (prefer experience with LIMS, and CDS –Chromatography Data Systems

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Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

R63209

Responsibilities:

• Execute commissioning, qualification, and validation (CQV) activities for mechanical equipment and systems utilized in Biopharma manufacturing facilities, adhering to regulatory standards and industry best practices.
• Create, assess, and implement validation protocols and reports for mechanical systems and equipment.
• Engage in the formulation of Standard Operating Procedures (SOPs) relevant to CQV processes.
• Conduct risk assessments to identify and analyze potential hazards associated with mechanical equipment and systems in Biopharma production.
• Offer technical support for HVAC and design tasks, including the design, commissioning, and validation of HVAC systems and equipment.
• Collaborate with internal and external partners to provide technical insights and assistance for HVAC and design-related projects.
• Review and provide feedback on engineering drawings, equipment specifications, and design documents.
• Manage administrative duties related to CQV, HVAC, and design activities, including scheduling, tracking, and document management.
• Lead and oversee small CQV, HVAC, and design projects as assigned, coordinating project team members and ensuring adherence to deadlines.
• Ensure compliance with regulatory standards, including cGMP, FDA, and ICH guidelines.
• Stay updated on industry trends and best practices concerning CQV, HVAC, and design activities, offering recommendations for ongoing improvement.
• Demonstrate strong interpersonal, written, and verbal communication skills.
• Contribute to and support high-performing, cross-functional teams.
• Adhere to client-specific work instructions, policies, and procedures.
• Act as a subject matter expert in the manufacturing process.
• Analyze and document production data using standard scientific methodologies.
• Assist with troubleshooting throughout the project lifecycle as needed.
• Participate in multiple projects or tasks of moderate scope and complexity as part of a team, requiring minimal supervision.
• Provide coaching in computerized system validation, hardware qualification, and IT compliance.
• Support business development initiatives.

Profile:

• Completed scientific or technical studies (e.g., Pharmacy, Biotechnology, Engineering, Chemistry).
• Minimum of 6 years of practical experience in a biopharmaceutical laboratory or process environment.
• Strong understanding of GMP and comprehensive knowledge of additional regulatory requirements (FDA, EU, GxP, ISO13485, GAMP5).
• Experience in validating equipment, systems, and processes in a pharmaceutical manufacturing setting (preferably in a greenfield context).
• Familiarity with statistical analysis tools and techniques for data evaluation, including Design of Experiments (DoE) and Statistical Process Control (SPC).
• Basic knowledge of networking and system setup.
• Understanding of manufacturing process steps and fundamental concepts of software programming.
• A self-starter capable of working independently and collaboratively in a team setting.
• Proven experience with SAT for commissioning production equipment.
• High quality awareness, excellent communication skills, and the ability to work within interdisciplinary teams.
• Willingness to travel.
• Customer-oriented approach to work

Our client is in Scientific and Medical industry. Due to their current expansion plan, they are looking for a Service Engineer to join their Engineering Team, in hopes of developing the current high performing team. They are located in the Central area – easily accessible.

Duties of Regulatory Compliance Specialist:

• Ensure compliance with regulatory standards for medical devices and biotechnology products, preparing and submitting necessary documentation.
• Assist in product registration, renewal, and change submissions, liaising with regulatory agencies and suppliers.
• Develop regulatory strategies and provide guidance during product development for timely market access.
• Maintain accurate regulatory documentation and records for submissions and approvals.
• Support Quality Assurance to ensure regulatory compliance and participate in audits when needed.
• Collaborate with internal teams to integrate regulatory requirements into product launches and provide regulatory training.
• Identify regulatory risks and develop mitigation strategies for product marketing and commercialization.
• Monitor post-market safety data, reporting adverse events as required by authorities.

Requirements:

• Degree in Life Science or related field
• Relevant experience

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

We regret that only shortlisted candidate will be notified

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