Total 602 talent acquisition 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

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

Contract QC Specialist

· Office Hours 5 Days (8am – 4.30pm) (start early end early)

North area

up to 5500

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

• Author of Method validation/verification/transfer Protocols, Reports, Reports, ensuring GMP compliance in ICH Q2(R1), USP <1225>, USP <1226>, EU GMP Chapter 6, and WHO Annex

• Ensure timely release of methods to support commercial production, manufacturing investigations and product investigations

• Ensure RFT in the method introduction process

• 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

How to Apply: send your resume to: [email protected] or telegram @jocelynchan ASAP!

Jocelyn Chan| Consultant | Recruit Express Pte Ltd (Healthcare & Lifescience) Company EA Licence number : 99C4599 Personnel EA License: R1331820

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

Tanjong Pagar

M-F, 9am to 5.45pm

Senior Specialist (3-5 years) - $4,100 to $4,700

(1)to handle communications between Global Compliance, TMA and entities

(2)to prepare presentations and explanations and status reports of current compliance activities

(3)to support compliance meetings and discussions

(4)minute taking of meetings

(5)to support investigation proceedings

(6)to support follow up of countermeasures and action plans with stakeholders

(7)administrative support for compliance areas

How to Apply: send your resume and indicate role(s) you want to apply to: [email protected] or telegram @jocelynchan

Jocelyn Chan| Consultant | Recruit Express Pte Ltd (Healthcare & Lifescience) Company EA License number : 99C4599 Personnel EA License: R1331820

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.

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

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

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

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

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

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

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

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

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

10. Other projects as assigned.

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

Responsibilities

• Manage and optimise utilisation for the vessels within Region XXX across all allocation scopes (trades), all Geo Froms for full and empty containers
• Responsible for Allocation and Capacity Management on designated Ship Systems / Trades
• Creation of Voyage Allocations and Customer Allocations as per alignment with TM Pricing & Steering
• Define allocation management steering measures to control the booking uptake in line with the trade strategy (e.g. managing contribution baselines for cargo acceptance)
• Monitor and predict the voyage utilisation based on booking developments and initiate corrective measures where required
• Monitor key connections between services at transshipment ports and initiate corrective booking acceptance measures where required.
• Monitor the uptake and follow up with relational TMPS and internally with TM Cargo Controllers handling other SSYs
• Handle waitlisted shipments
• Prioritise cargoes for loading/shut out when required considering commercial rules as well as operational and cost aspects
• Drive the performance for the Cargo Control KPIs – utilization, QP3 fast booking response, QP7 Loaded as booked and dwell time reduction
• Reduce operational costs resulting out of our cargo flows to a minimum (renominations, storage)
• Liaising with ship planners (own or partner line) on space related topics and operational restrictions (e.g. draft, ballast & bunker, stack weight, etc)
• Responsible for special cargo approval applications (e.g. OOG, Flexi tank) to planners/partner lines
• Liaise with QSCs and GCC for Customer Service related topics (e.g. vessel balancing) as well as Cargo Operations topics (e.g. terminal build up, load lists)
• Cooperate closely with TM Pricing & Steering and the Commercial Organisation (e.g. Global Account Management, Commercial Steering) regarding booking development and respective market situation
• Liaise with the Commercial Organisation (Regional Commercial, Global Sales) regarding uptake performance push
• Consultation on required schedule recovery measures in collaboration with Operations
• Create tactical forecasts where required as per joint working procedures considering expected booking development also on connecting services
• Provide input to capacity requirements when needed e.g. shuttle or feeder space requirements.

Job Requirements

• Degree in Shipping, Transportation or related discipline
• Minimum 3 years’ experience in liner shipping/ transportation industry
• Operational background and Trade Management or Commercial Steering experience welcome
• Comprehensive knowledge about HL applications (FIS, Qlik.) (Advantageous)
• Proficient in MS-Office products (Excel, PowerPoint)
• Analytical, systematic and efficient way of working
• Motivated, proactive and reliable
• Willing to take ownership of tasks and responsibility
• Teamplayer with strong communication skills
• Excellent negotiations skills and assertiveness
• Acceptance of flexible working times also on holidays/weekends
• Experience in dealing with different stakeholder groups
• Ability to develop and implement new concepts and structures
• Knowledge about Hapag-Lloyd’s global product offering (Network & Partners) (Advantageous)

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

1. Perform analytical equipment lifecycle management as per current regulatory requirements / SOP.
2. Involve in equipment qualification, writing URS, reporting and implementing SOP’s for system operation and maintenance, monitoring performance of the equipment and decommissioning of equipment.
3. Ensure real time documentation, maintain data integrity and appropriate traceability.
4. Support and / or perform maintenance / calibration of laboratory equipment in compliance with established schedules.
5. Liaise with vendors/service providers for PM / Calibration in a timely manner.
6. Responsible for maintenance / calibration planning of equipment within QC Department.
7. Responsible for the accurate, timely and compliant execution of assigned projects and related documentation.
8. Assist / perform method validation and transfer as required.
9. Conduct QC Department equipment operation and maintenance training to QC staff as required.
10. Perform and / or support in maintaining the asset register for equipment in the QC Department.
11. Initiate CAPEX for equipment purchase.
12. Responsible for QC lab and equipment/instrument cleanliness.
13. Any other activities as and when assigned by the Superior.

EDUCATION & EXPERIENCE:

EDUCATION: Degree / Diploma in science related discipline (e.g. Chemistry, Chemical Engineering, Biotechnology).

EXPERIENCE: Minimum 4 years of quality control experience in pharmaceutical manufacturing industry.

KNOWLEDGE & SKILLS:

1. Possess working knowledge of GMP in the pharmaceutical industry.
2. A good team player with positive learning attitude.
3. Working knowledge of validation, calibration and operation of laboratory equipment such as HPLC, GC, FTIR and Dissolution equipment.
4. Excellent interpersonal and analytical skills, good verbal and written communication skills.

Role:Capability and Quality Management Specialist

JD:

Responsibilities
• Evaluate individual staff performance through regular quality audits to ensure all customer interactions meet professional, quality and compliance guidelines
• Conduct regular call sharing with staff to ensure alignment of best practices and high service standards
• Identifying training and development needs through analysing data to identify areas of improvement
• Conduct thematic reviews examining themes across multiple products, services or processes to identify trends, patterns and common issues
• Supporting in the design of training and development programmes based on the needs of the organization and the individual;
• Supporting in evaluation of training and development programmes;

Requirements
• A recognized degree / Graduate
• Knowledge/working experience of Singapore Insurance is preferred
• Good learning attitude, analytical, problem solving and with good time management skills.
• Excellent interpersonal and communication skills with an ability to write well
• Experience in a customer service environment or related position, preferably in a financial industry
• Must be proficient in English language
• Committed, self-disciplined, Customer Service oriented, able to multitask with an eye for details.
• Ability to work independently, and with high level of initiative in a high pressure and tight timeline environment
• Team worker, works well under pressure and self-driven

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

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.

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.

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. Strong Experience in end to end projects for system implementation, integration, upgrade and support of Actimize/ NetReveal systems.
2. Experience in handling data mapping, data validation and alert validation.
3. Participate in the technical workshops during the analysis and design stages of project and collaborate with Architects, Security and Development Lead to ensure solution design complies with enterprise design principles, security and control standards
4. Trouble-shoot environmental & technical issues that arise in the course of deploying/configuring software and escalate issues that impacts project schedule on timely basis and propose workarounds/resolutions.
5. Collaborate with Test Management teams to ensure completion of SIT, UAT, performance / load testing and application security testing with quality result
6. Strong Actimize AML (IFM, RCM, CTR) or Netreveal modules (ETL Builder, Workbench, Visualizer, Application Builder etc) - Compliance, Anti-Money Laundering Domain Experience.
7. Well versed with data feeds required for SAM solution including Actimize architecture. Built and managed development of RCM custom java plugins. Experience in Analysis of Actimize model specs and transforming those specifications into a language understood by the business;
8. Specify and fully document custom Actimize models that would bear scrutiny by an internal audit or external regulators.
9. Having expert hands on experience in RCM administration, GUI customization and other configurations.
10. Experience in performance tuning, configuration application, database and solution level validation. It covers data evaluation and identify data gap/issues. Global implementation and upgrade experience is a plus.
11. Excellent communications skills required to be able to work with various stake holders including business analysts and run the project efficiently.
12. Provide technical guidance and leadership to the project teams throughout all project phases, from planning, resourcing to production deployment and beyond.

Key Requirements –

1. Min 7 years’ experience or equivalent in a technical role such as programming, technical/IT support, software installation.
2. Good knowledge of SQL and in-depth experience of databases such as Oracle, DB2, SQL Server or Teradata and performance tuning at a database level
3. Technical trouble shooting skills
4. Previous experience of installing software, creating test environments
5. Good knowledge of operating systems such as Linux, HPUX, Google Cloud Platform, Windows
6. Understanding of Java and J2EE architectures/and/or Data Server
7. Good experience / knowledge working with JBoss, Weblogic, MQ, Apache Kafka and Spark
8. Experience in AML/KYC ecosystem and technologies Actimize/ Netreveal

Job Description

• Responsible to review and approve the Quality Control related protocols, reports, procedures and other related documents to ensure compliance to internal procedures and regulatory requirements.
• Evaluate and approve discrepancy related to qualification/validation protocols in order to guarantee documentation of the incidents and identification of corrective actions.
• Support collaboration and participations in projects as Quality Representative
• Provide validation expertise, oversight and support for the development
• Provide quality oversight on the Quality Control validation maintenance activities and Master Validation Plan.
• Support in multisite initiatives to ensure harmonization of Quality Systems and qualification/validation related activities between the plants.
• Responsibility to adhere to any applicable EHS requirements.

Requirements

• Min degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, engineering.
• A minimum experience of 2-3 years in the pharmaceutical or biotechnology in quality assurance, manufacturing operations or validation

Interested candidates are invited to email your resume to:

[email protected]

Jenalyn Ooi Huai Sian (R1765551)

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

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

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

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

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.

Job Description:

• Contribute to Life Science projects for Antaes Asia clients
• Act as a key member of the Quality Systems team, providing quality oversight for validation activities, including the critical area of Data Integrity
• Ensure compliance with regulatory standards and internal policies for all validation processes
• Collaborate with Subject Matter Experts (SMEs) and the validation team to conduct gap analysis and risk assessments prior to qualification activities.
• Identify potential gaps and risks, proposing effective mitigation strategies to ensure compliance and operational excellence.
• Participate in investigations related to validation discrepancies and assist in reviewing and approving discrepancy reports.
• Support the closure of Corrective and Preventive Actions (CAPA) associated with validation issues, ensuring timely and effective resolution.
• Review and approve a wide range of validation documentation, including but not limited to protocols and reports, ensuring accuracy, compliance, and alignment with quality standards.
• Provide critical feedback and ensure that validation documents meet regulatory and company requirements.
• Serve as a resource for validation-related queries and issues, providing guidance to teams and ensuring swift resolution of problems.
• Review and approve Standard Operating Procedures (SOPs), FORMs, Manufacturing Batch Records, and other relevant procedural documents to ensure they align with current good manufacturing practices (cGMP) and company policies.
• Contribute to the promotion of Antaes services on top of assistance provided to clients

Job Requirements:

• Bachelor’s Degree in Biomedical Engineering, Biotechnology, Science or equivalent
• 2-4 years of experience in a Quality Systems role within the pharmaceutical or biotechnology industry
• Experience with validation processes and quality oversight, including data integrity
• Strong understanding of cGMP regulations and validation principles
• Experience with risk assessment, gap analysis, and CAPA processes
• Problem-solving ability with a focus on proactive solutions and process improvement
• Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills
• Excellent communication skills, both written and verbal, in English

Job Description:

• Contribute to Life Science projects for Antaes Asia clients
• Perform detailed reviews of raw materials, intermediate products, and finished products for compliance with quality specifications.
• Manage the release process by ensuring all quality checks are completed before approving materials and products for use or distribution.
• Ensure that all batch records and associated documentation are reviewed and meet regulatory requirements before product release.
• Provide on-site quality oversight during the manufacturing process, ensuring that all operations comply with Good Manufacturing Practices (GMP) and company quality standards.
• Collaborate with manufacturing teams to address any quality-related issues that arise during production and ensure prompt resolution.
• Conduct regular GEMBA (on-site workplace observation) and GMP (Good Manufacturing Practice) walk-throughs of the manufacturing floor to identify potential quality risks, ensure compliance, and promote a culture of continuous improvement.
• Document findings from walk-throughs and collaborate with the relevant teams to implement corrective actions where necessary.
• Review, revise, and approve Standard Operating Procedures (SOPs), forms, and Manufacturing Batch Records to ensure they are up to date and compliant with current regulations and company policies.
• Ensure that all documentation aligns with current industry standards and best practices in pharmaceutical manufacturing.
• Contribute to the promotion of Antaes services on top of assistance provided to clients

Job Requirements:

• Bachelor’s degree in Biotechnology, Pharmaceutical or related field
• 3-5 years of experience in quality assurance within the pharmaceutical or biotechnology industry
• Experience with product and raw material release processes and related documentation
• Strong knowledge of GMP (Good Manufacturing Practices) and regulatory compliance
• Hands-on experience in conducting GEMBA or GMP walk-throughs and identifying quality risks
• Proficient in reviewing and approving procedures such as SOPs, forms, and batch records
• Strong attention to detail and ability to work in a fast-paced, regulated environment
• Excellent communication and collaboration skills to work with cross-functional teams
• Good communication and problem-solving skills

Company Information

Thermo Fisher Scientific (NYSE: TMO) is a global leader in the field of science, dedicated to improving the world's health, cleanliness, and safety. With a proven track record and a highly skilled workforce of over 30,000 employees, we are committed to delivering exceptional solutions to our diverse customer base. We proudly serve over 350,000 customers, including pharmaceutical and biotech companies, hospitals, universities, research institutions, and government agencies. Our renowned brands, Thermo Scientific and Fisher Scientific, provide a comprehensive range of advanced analytical instruments, laboratory equipment, software, services, consumables, and reagents. Our innovative technologies empower scientists and researchers to expedite scientific breakthroughs and contribute to advancements in healthcare, environmental preservation, and more. Join our ambitious team at Thermo Fisher Scientific and become part of the force shaping the future of science.

Job Description

As a Compliance Specialist III, you will be a crucial member of our Research division, ensuring that our business operations adhere to global trade regulations and Thermo Fisher policies. Your extensive experience in trade compliance will be instrumental in achieving smooth imports and exports. Working collaboratively with colleagues throughout the organization, you will provide training, guidance, and assessments to promote compliance and minimize risks. Your responsibilities will also include handling transactional activities related to import and export regulations, such as goods classification, license applications, and completion of necessary documents. Additionally, you will support our Global Trade Compliance Team by conducting assessments and audits, resolving compliance issues, and implementing corrective measures. Your technical expertise and meticulousness will ensure that our operations consistently meet the highest standards of compliance and integrity.

Responsibilities:

• Provide training and guidance on import and export regulations
• Conduct assessments and audits to ensure compliance
• Assist in resolving trade compliance matters
• Collaborate with Legal counsel on government audits and possible violations
• Coordinate with other team members on process development and risk evaluation
• Manage multiple projects involving cross-business functionality

Requirements/Qualifications:

• Bachelor's degree or equivalent experience in import or export
• 5-10 years of trade compliance experience focused on import/export
• Technical or scientific background preferred
• Experience in logistics and Customs (Import) Broker's license is a plus
• Proficient in MS Office
• Excellent oral and written communication skills
• Excellent collaborator with the capability to work autonomously
• Exceptional organizational skills

Apply today! http://jobs.thermofisher.com