Total 471 sales specialist job vacancies in Quality Assurance / Control category in Singapore

• Calibration of pressure, temperature, pH and instruments in laboratory and customer sites.
• Familiar with CMC table and able to calculate CMC and uncertainties for pressure and temperature.
• Lab/ onsite ISO-17025 calibration jobs.
• Familiar with ISO/IEC 17025: 2017 & ISO 9001: 2015 requirements.
• Assist in lab audits
• Ad hoc duties

Requirements:

• Min Diploma/Degree in Engineering
• Min 2-3 years of laboratory experience in pressure, temperature and PH testing methods
• Familiarity with a quality system such as ISO 17025 or ISO 9001.

Interested & qualified applicants, please forward your latest CV in MS word format to [email protected]

• 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

Jobscope

• 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.
• Develop and maintain document control process for efficient management and record all documentation
• Ensure proper document classification, sorting, filing and proper archiving
• Performs document quality check in accordance to company ISO document control procedures.
• Review and maintain the accuracy of the records, editing where necessary to ensure they are up to date.
• Undertake various functions related to document control, document archiving, document imaging and maintenance of document register
• Provide administrative support on the area of drafting document control and documentation.

Requirements

• Diploma/ Degree in Science or any related Engineering
• Quality Assurance experience is advantageous
• Pharmaceutical GMP / Lifescience environment will be highly preferred

Apply now by sending your resume to [email protected] for more enquiries.

We regret to inform you that only shortlisted candidates will be notified.

Tammy Yap | Outsourcing Team | EA License Number: 99C4599

Recruit Express Pte Ltd Company Reg. No. 199601303W

Responsibilities:

• Execute Environmental Monitoring sampling activities as per the defined location under cGMP.
• Execute compendial method testing such as TOC, Conductivity, Endotoxin, Bioburden when applicable under cGMP
• Track and execute individual training requirements are completed on time to perform sampling under cGMPs and other newly assigned areas of work.
• Follows the priorities for Laboratory equipment documentation, labeling and archiving.
• Ensures sampling delivery is performed in a timely manner.
• Handle data for of SAP entry data and sample dispatching to the required location
• Compiles documents in a complete, accurate and consistent manner to ensure that samples, materials or products and intermediates have been tested, or inspected according to specification and cGMPs.
• Explain, his/her area of work, in health authorities inspections and internal audits
• Other duties assigned by direct supervisor.

About You:

• University Degree in Science related discipline (e.g. chemistry, biology, pharmaceutical sciences, or equivalent experiences)
• Minimum 2 years of experience in a Quality Control Function
• Analytical thinking with problem solving and writing skills
• Motivated and independent
• cGMP/GLP knowledge on QC Lab Equipment and QC testing
• Good communication skills and Strong ability to work cross functional teams
• Ability to work towards timeline

Position: Financial Control Specialist

Location: Tampines - EW2 MRT

Salary: Up to $2700

Job Description:

• Report team leads
• Performs accounting duties in compliance with financial policies and procedures
• Manages day-to-day invoice activities, including verification, processing, and reconciliation
• Provides essential support to the accounts payable team
• Collaborates with internal and external stakeholders
• Ensures timely and efficient handling of invoices

Good to have:

• Accounts payable experience
• Analytical and problem-solving skills to assess financial data and identify trends
• Strong communication skills for interacting with internal and external stakeholders

By submitting any application or résumé to us, you will be deemed to have agreed and consented to us disclosing your personal information to prospective employers for their consideration.

We regret to inform you that only shortlisted candidates will be notified. All applications will be treated with the strictest confidence.

Elitez Pte Ltd | EA Licence: 16C8004| Hailey YANG | Registration No: R1876431

Job Scope

• Responsible to review and approve master batch records and subsequent batch records
• Conduct internal and external audits
• 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.
• Maintain inspection readiness and support inspections from regulatory agencies and customers.
• Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state.
• Support the maintenance of validated stated of GMP systems and processes.
• Facilitate and prepare regulatory submissions and attend to regulatory queries in a timely manner

Requirements

• A Bachelor Degree in Science / Chemical Engineering or equivalent with relevant pharmaceutical experience.
• Minimum 3 relevant years of Audit & Vendor management experience in Pharmaceutical industry
• 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.

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

Tricia Celestine Goh (R1981653)
Recruit Express Pte Ltd | Company Reg. No. 199601303W | EA License Number: 99C4599

Job Title: Quality Control Specialist in Jurong Island

Job Description:

• 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

Job Requirements: -

• Diploma in Chemical Process Technology / Chemical Engineering.
• Preferred candidates with min. 1 year of relevant working experience in the Laboratory fields (chemical / pharmaceutical industry) or fresh Poly graduates are also welcomed.
• Hands-on experience in operating laboratory equipment such as injection molding & gas chromatography will be an added advantage.
• Team player, good integrity and willingness to learn as training will be provided.

Other Information

• 5 days' Work Week from 8,30am - 5.30pm
• Willing to work in Jurong Island starting 8.30am
• Company transport provided at Outram Park and Jurong East MRT station.
• Must be able to work overtime when required.
• Basic Salary ranging from $2500 - $3200.
• AWS + Variable Bonus (UP 3-4 mths)
• Jurong island site allowance $220 + Transport allowance $140

If you possess the above-mentioned Chemical process with Lab experience and you like what you see, interested applicant.

Kindly send in your resume. We regret only shortlisted candidates will be notified.

EA License No. 14C7092

EA Registration No: R1110882

EA Personnel: Lee Ming Er

Job Title

Control IT Software Specialist

Job Description:

Do you like to take an extra step, analyzing the root cause of a failed software component or interface, and providing solutions for the cause?

Vanderlande understands the complexities associated with a successful airport and parcel operation and delivers future-proof logistic process automation. These automation systems are composed of many Electromechanical, IT, and control components that require expert knowledge to support.

As an IT System Control Specialist, you will analyze and assist in servicing baggage handling system control software. You are responsible for helping the operation and maintenance team find and resolve system issues, researching solutions, and proposing changes to the system. You will have frequent contact with internal and external customers and third-party contractors.

As an IT System Control Specialist, you have a strong affinity with Oracle data administrator and Java-oriented software combined with the Linux platform they run on.

Key responsibilities:

· Identify problems and perform root cause analysis of upper-level control software of Vanderlande baggage handling system, in close collaboration with other teams.

· Review system and application logs to trace issues and gather information for analysis.

· Develop and maintain customer-specific validation test processes and reports for change control log.

· Continuously monitor IT infrastructure, application, and material handling application environment.

· Triage all events reported and maintain incident reports.

· Planning and delivering preventive maintenance tasks & assigned change tasks (back-ups, patch execution, etc.)

· Have a systematic way of troubleshooting a problem.

· Advise the customer on actions to minimize equipment downtime.

· Take proactive measures based on own insight, lifecycle plans, or preventive maintenance plans.

Qualifications:

· Bachelor’s degree in computer science engineering, information technology, information systems, mathematics or a related field of study.

· Preferably you have a good understanding of IT service management practices (ITIL v3/v4)

· Affinity with IT and Industrial Automation and interest in logistic processes.

· 5 years of relevant working experience in industrial systems.

· Hands-on experience with Oracle SQL and JAVA software development is preferred.

· Hands-on experience with LINUX and network communications is preferred.

· Basic knowledge of IT infrastructure and software development

· Basic knowledge of testing methodologies and troubleshooting techniques

· Good communication skills in English.

· Assertive team player and proactive.

· May have to work after hours and weekends as the operation runs 24/7.

• 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

About our client: Our client is a leading global manufacturer of specialty chemicals, resins, fibres and textiles.

*This role will be based in our client's chemical manufacturing facility in Jurong Island.

About the role:

• Establish, implement, maintain & improve the management systems, namely: ISO 9001, ISO 14001, SS 651
• Establish, implement, review & improve on management systems’ documentation, namely: policy, objectives, manual, procedures, forms, etc.
• Manage all system certification, improvement, and upgrade issues.
• Plan, manage and execute all internal and external management system audits to ensure timely closure of issues raised during the audits.
• Plan and conduct management reviews.
• Develop and oversee the implementation of all QA activities and support in HSE activities.
• Follow-up on issues to ensure timely closure of HSEQ-related reports, namely: customer complaint reports, corrective action reports, incident reports, etc.
• Prepare and submit Monthly reports.
• Support in the preparation and submission of the Safety Case.
• Participate as a team member in risk / HSE assessment team.
• Participate in external provider audits, where applicable.
• Coordination of Global QA initiatives and projects.
• To perform any other duties or assignments as assigned by superiors.

About you:

• Holder of diploma or degree in engineering or related field.
• Minimum of 5 years of work experience in Quality Assurance, Health and Safety in chemical / petrochemical industry.
• Good understanding of quality management systems like ISO 9001, ISO 14001, SS 651.

*Only shortlisted candidates will be contacted. Thanks for your interest.

EA Name: Kingsforce Management Services Pte. Ltd.

EA License: 94C3545

EAP Name: Paola Jane Ofrasio Fajardo

EAP Reg. No.: R1325507

Contract, Office hours, 5 days

Position Overview

Carries out quality control functions related to the manufacture, testing, and release of investigational products used in Phase I/II/III clinical studies. Responsible for the inspection, sampling and disposition of raw materials used in the manufacture of drug products. Conducts investigations and determines corrective actions of process and product deviations. Requires an ability to function effectively under timeline pressure and to provide solutions to a wide range of problems.

Main Areas of Responsibilities

• Investigates and resolves laboratory incidents.
• Performs the quality assurance review and approval of laboratory investigation reports including out-of-specification reports.
• Determines if corrective and preventative actions are adequate and evaluates the impact on materials.
• Performs quality assurance review and approval of analytical procedures for compliance with company policies, ICH and regional requirements.
• Assists in the preparation of quality agreements and performs periodic supplier evaluations to ensure compliance with regulatory requirements and company policies.
• Performs incoming quality control inspection of raw materials to ensure compliance to specifications and departmental procedures.
• Performs sampling of raw materials and coordinates with production planners and testing laboratories to ensure raw materials are tested and retested at the required inspection intervals.

Requirements

• Good knowledge of cGMP pharmaceutical manufacturing and inspection requirements of pharmaceutical products.
• Min Degree in Science or equivalent with at least 2 years of relevant experience in the pharmaceutical / chemical industry.
• Experience in operating laboratory equipment such as HPLC, GC , KF Titrators.

If you are interested in the position, do kindly drop your most updated resume to [email protected] (Attn: Senior QC)

Thank You.

Lynn Ho
R23114223

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

The Opportunity

• Opportunity to work with in a leading US MNC, manufacturer of dental products and technologies
• The Compliance Specialist/ Manager will be the primary compliance advisor for and liaison across the businesses in the Southeast Asia and India region
• 6 months contract
• Location: Central-East (Hybrid Work Arrangements)
• Salary: Up to SGD 15,000 per month (Subjected to experience)

The Requirement:

• Bachelor's degree in a related field or equivalent experience
• Minimum 5+ years of compliance experience within a regulated industry in a multinational environment
• Healthcare/Medical Device industry will be an added advantage
• Great organization skills and time management
• Able to pick up and understand our compliance policies quickly and provide advice based
• Solid analytical skills with the ability to respond to complex challenges with innovative solutions
• Able to seek buy-in from management on compliance requirements.

Job Description:

• Drafts, implements, maintains and/or revises relevant local compliance policies, procedures, guidance and other related documents.
• Assesses ethics and compliance risks and implements localised compliance controls and other mitigating measures, as needed.
• Collaborates with HR and/or Legal to provide guidance to management and employees, and to resolve legal compliance issues, as necessary.
• Monitors the business for compliance with Company standards and procedures.
• Implements the Business Gifts and Entertainment Policy, providing guidance as needed on local regulations.
• Lead and/or assist with internal investigations as directed by the regional and/or global Ethics & Compliance and/or Legal departments.
• Supports the company’s Data Privacy program needs, including compliance with various local Data Privacy laws, working with Legal and Global Ethics & Compliance teams.
• Develops an effective compliance training program, including appropriate introductory training for new employees as well as ongoing training for all employees and managers.
• Participates in compliance-related legal and data privacy processes and projects as necessary.

Next Step

• Interested applicants, prepare your updated resume and click "Apply here" or email to [email protected]
• All shortlisted candidates will be contacted.

Quality Manager is a key role in the team responsible for engaging with various functions from Sales, Tendering, Engineering, to Operations on the implementation of integrated execution work processes and governance. Deployment of operational tools and deriving meaningful insights for continuously improving operational performance.

This role also involves the quality aspect in ensuring our offer quality to meet customer satisfaction and customer promise according to the whole customer journey mapping.

ROLES & RESPONSIBILITIES

Operation Excellence and Tools

• Deploy the execution processes and playbooks deployment and compliance.
• Ensure good implementation & adoption of Execution tools (BFS, SAP, etc.).
• Provide business analytics for Execution – revenue, margin, WIP, warranty cost, failure rate, utilization, etc.
• Responsible for driving initiatives throughout the execution to improve productivity, efficiency, cost management and continuous improvement.

Quality

• Defining offer and project quality goals including customer effort goals all along life cycle.
• Supporting and coaching the team on methods and quality tools needed to reach robustness, customer satisfaction and quality targets.
• Creates and enforces the project quality plan.
• Participating in customer quality case in supporting the team to identify issue root cause and implementation of improvement action plans and best practices sharing.

Requirements:

• Minimum Degree in Engineering or equivalent
• Minimum 5 years of experience in similar capacity
• Knowledge in Change management, Six Sigma and risk management
• Proven leadership and experience in influencing without authority
• Proficient in computer skills including MS Word, Excel, PowerPoint, Chinese word processing
• Good knowledge & experience on quality tools & methodologies for process/products improvement

ESSENTIAL JOB FUNCTIONS

• Compile quality metric data required for management reporting and prepare sections of quality metric reports.
• SOP writing and issuance for site qualification and validation project as and when needed.
• Identify deviations and potential risks in manufacturing systems, processes and methods, and their possible causes.
• Implement validation processes to review systems, methods and processes utilised in manufacturing facilities.
• Access impact to validation for changes that occur during the project and define appropriate validation requirements and approach to meet these requirements.
• Identify potential compliance risk and gaps and recommend improvements.

EXPERIENCE REQUIREMENTS

• Min Degree in related specialisation
• More than 5 years QA experience in a Bio-Lifescience environment

Interested candidates please send a copy of your resume in MS Word to

[email protected]

EA Personnel: Valerie Yong Kian Fung (R1103704)

Company Reg. No 199601303W

EA Licence No. 99C4599

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

The Quality Assurance (QA) Specialist is responsible for the development, implementation and promotion of QA related activities and compliance in the company. He/ She is also responsible to:

• Establish, implement, maintain & improve the management systems, namely: ISO 9001, ISO 14001, SS 651.
• Establish, implement, review & improve on management systems’ documentations, namely: policy, objectives, manual, procedures, forms, etc.
• Manage all system certification, improvement and upgrade issues.
• Plan, manage and execute all internal and external management system audits to ensure timely closure of issues raised during the audits.
• Plan and conduct management reviews.
• Develop and oversee the implementation of all QA activities and support in HSE activities.
• Follow-up on issues to ensure timely closure of HSEQ-related reports, namely: customer complaint reports, corrective action reports, incident reports, etc.
• Prepare and submit Monthly reports.
• Support in the preparation and submission of the Safety Case.
• Participate as a team member in risk / HSE assessment team.
• Participate in external provider audits, where applicable.
• Co-ordination of Global QA initiatives and projects.
• To perform any other duties or assignments as assigned by superiors.

The Wealth Platform tribe defines and delivers advanced advisory initiatives, bringing great value to Clients and to our Front Office teams. We are part of the Product team (PMG) and work in close partnership with business stakeholders and the technology teams.

We are looking for a Subject Matter Expert (SME) of Aladdin system (BlackRock) to focus on the Portfolio Management system enhancement (Aladdin).

The role holder supports key transformation initiatives impacting portfolio management capabilities., in partnership with the technology team. He/she manages overall project delivery is effectively managed within defined and agreed service level to drive and support business needs. The SME supports Aladdin Product Owner, ensuring that the system is robust in supporting the overall business and the risks are managed accordingly.

The candidate is required to have the following experience:

• In-depth knowledge of Aladdin (BlackRock), Aladdin Enterprise preferred.
• Agile project management practice and experience in the Scrum framework

The SME supports the product owner for the product vision and roadmap, works with squads and project teams to ensure timely delivery. This is a persistent role that goes beyond an individual projects.

Main duties:

• Supports the PO to define the Product Backlog. Works with users (e.g.: thorough customer journeys) based on the expertise in system capabilities and functionality to capture and prioritize the features and user stories expected of the products.
• Partner with Tech teams to refine user stories, including acceptance criteria.
• Support the PO to coordinate dependencies with internal and external teams.
• Coordinate and validate system requirements gathering and drive acceptance testing phase with end users, testers, and relevant product teams.
• Monitor and ensure platform readiness and uptime for efficient daily use.
• Work closely with IT stakeholders to track platform related incidents and defects to timely and permanent closure. Monitor and ensure platform readiness and uptime for efficient daily use.
• Handle end user queries related to platform functionality.
• Conduct regular platform training and onsite guidance to end users.
• Liaise with business process owners to align processes within platform.

Requirements:

• Degree in Finance, Economics, Business, Computer Science or Technology
• Possession in Agile project management, Scrum and relevant certifications or qualifications are advantageous.
• Minimum of 5 years of experience in Banking / Financial institutionsIn depth knowledge of Aladdin Wealth / Enterprise (BlackRock)
• Experience in Discretionary Portfolio Management products, processes and best practices
• Sound understanding and articulation of Wealth Management business products, processes, and best practices.
• Strong advocate for operational efficiency and enhanced end user experience
• Excellent written and verbal communication and presentation skills coupled with strong computer skills, particularly in Microsoft Office tools.
• Demonstrable ability to engage closely and confidently with business and IT stakeholders of all levels.
• Ability to prioritise, work well under pressure, work well independently, and be a team player.

COMPANY DESCRIPTION

Kaplan is one of the world’s largest and most diverse education providers with over one million students globally. Headquartered in US, Kaplan is part of Graham Holdings (formerly The Washington Post Company) and is its largest subsidiary.

Kaplan in Singapore has students from over 35 countries and regions. As a Lifelong Integrated Learning Partner, we offer over 450 academic programmes for higher learning and professional certification courses for skills development, providing opportunities for individuals to always stay relevant. To date, these opportunities have benefitted over 95,000 graduates.

We have a diverse team of individuals dedicated to our mission to help individuals achieve their educational and career goals, and build futures, one success story at a time. Our core values – Opportunity, Knowledge, Support, Integrity and Results – help guide the way we work.

At Kaplan, we provide a stimulating and professional working atmosphere with plenty of room for initiatives and growth. 

If you are seeking for challenges and enrichment, we welcome you to write to us at : [email protected]

RESPONSIBILITIES

• Coordinating SOX reporting for Tier 1 SOX entity (ensuring timely completion of reporting responsibilities):
• Providing support to the international SOX teams
• Performing Entity Level Controls (ELCs) testing
• Updating process documentation and remediating deficiencies in the international businesses
• Identifying risks and controls gaps, and to design, redesign and evaluate existing compliance measures
• Ad hoc projects – System migration baseline testing; Segregation of duties testing; Implementing controls for changes in business scope

• Bachelors Degree in Accountancy or equivalent 
• Qualified accountant or Internal Auditor
• Technically competent (ideally US GAAP) with proven ability to identify misstatements
• Significant audit experience (SOX experience desired but not essential) with knowledge of compliance and financial reporting
• Ability to work independently and manage your own workload
• Excellent communication skills
• Strong persuasive skills and ability to influence all levels
• Project management skills/experience
• Strong presentation skills
• Strong problem-solving skills
• Planning and organisation skills
• Ability to speak and write in fluent English

The Senior QA Specialist will lead and support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for multi-product s and also provides QA support for Audit Management.

Responsibilities:

• Monitor day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a large scale, multi-product, and GMP biotech contract manufacturing facility.

• Highly motivated individual and have superior skills in all areas relevant to the job.

• Member of cross-functional site team(s) on projects/ issues.

• Lead in complex deviation investigations, change controls, CAPA proposals and closure of discrepancy reports.

• Superior ability to troubleshoot.

• A competent Reviewer and Approver of SOPs, protocols, reports or records.

• Able to coordinate between departments for multiple parallel activities.

• Understanding of advanced topics pertaining to cGMP.

• Participate in Customer / Agency Audits and Inspections as required.

• Identify process pathways and work to develop improvements in strategy.

• Help/Transfer and quickly assimilate to leadership role in other process areas.

• Assume Supervisory responsibility in absence of supervisor

• Understands and articulates company business strategy. Maintains a broad view of the

  business, recognize changes and trends in the appropriate area in which the individual

  operates.

• Any other tasks as and when assigned by supervisor.

Requirements:

• Engineering/Science Degree or higher from recognized institution with 5 to 10 years’ experience in Validation / Quality unit in the Biopharmaceutical industry

• Familiar with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7).

• Good knowledge and experience of the practical and theoretical requirement of quality management system in GMP facility 

• Good interpersonal skills

• Effective Communicator (oral and written)

• Exhibit good quality decision making traits

• Meticulous, Systematic and Analytical Mind

• Team player who can operate independently, with strong focus on safety, quality and timelines.

• Main contact person for the third-party manufacturing and oversee the TPM operation/process.
• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Support to ensure that all quality goals are met, and all practices and procedures comply with company policies, GMP principles and applicable regulations for the quality areas.
• Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.
• Manage TPM documents, quality agreement, FMEA, ASL and TPM scorecard/KPI.
• Review, evaluate and approve all major deviations and determine the need for a corrective action. Document the deviation in the Trackwise system and perform product impact analyses.
• Review, evaluate and approve all TPM change requests for process related, commodity, raw material, SCN, QC and facilities. Initiate global change in the Trackwise system.
• Provide a constant review on the manufacturing process, equipment and facilities to assure compliance with procedures, specifications, and policies.
• Write, review and approve annual product report/product quality report.
• Actively involved in Pre-campaign activities, Post-campaign review (Track & trending program)
• Perform timely lot disposition in the SAP and LRMS/LotSmart system to meet shipment timeline and demands.
• Prepare CoA, CoC and release package for drug substance.
• Coordination of regulatory requests, including country submission, dossier review, GMP Renewal Program.

About You:

● Bachelor Degree with at least 5 years' experiences in pharmaceutical or biotech facility preferably familiar with Quality Compliance, QA Third-party manufacturing oversight and/or QA Operations.

● Knowledge of quality management system, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a pharma or biotech facility

● Relevant QA background from pharma or biotech environment is preferred

● Familiar with Health Authorities standards (e.g., FDA CFR and EU)

● Must be team player, meticulous, strong communication, analytical and organizational skills

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.

Candidate with strong QA background in API/Bio manufacturing plant and experience in external inspection management and internal audit

Main responsibility/scope:

- Conduct Internal audit, audit CAPAs follow-up (discussion of response) and management of open audit CAPAs

- Support external inspections (logistics and backroom support)

- Quality review of documents related to Data Integrity (Audit trail review, data integrity risk assessment, ERES assessment, Data Mapping)

- Support for other areas (Quality risk management, QMR tasks and regulatory submission) in terms of management of open tasks, revision/routing of documents

- Event organization and/or other administrative tasks as assigned by Manager/Delegate.

Role Purpose:

Sustain the local Quality System and infrastructure for the Singapore Hub (secondary packaging).

Carry out and provide quality oversight for the quality management to ensure compliance with applicable regulatory requirements and quality standards.

Main Accountabilities:

• Support Quality Systems and ensure effective use of Quality Tools for activities related to Good Manufacturing Practice and Good Distribution Practice.
• Act as the Key-User and Training Coordinator for training system. Ensure adequate training program is effective.
• Writes and co-ordinates the writing of SOPs and manages the administration of SOPs.
• Performs quality oversight of third party packager, distributor under area of responsibility as per compliance and business needs.
• Carry out Annual Product Reviews for Secondary Packaging.
• Carry out Batch Release for secondary packaging according to marketing authorizations and coordinate different activities with third party.
• Accountable for timely product releases avoiding backorders, while assuring product quality and compliance.
• Support Quality Review Board for Singapore Hub operations. Support in the issuance of monthly Quality status reports to monitor local GMP/GDP compliance.
• Investigate / assess deviations occurring during transport, packaging, storage, distribution of products.
• Support change control implementation.
• Carry out timely investigation of product complaints and ensure adequacy and timely implementation of CAPA.
• Coordinate potential recall activities, including mock recalls.
• Coordinate and perform self-inspection. Support inspection from regulatory authority and certified body.

Qualification and Experience Requirements:

• Educational requirements: relevant degree in pharmacy, chemistry, biology or health sciences.
• experience in the pharmaceutical industry, in operational quality is advantageous
• Good Experience in Quality Assurance with basic knowledge in Good Manufacturing Practice and Good Distribution Practice.
• Good command in English and writing skill.

Interested candidates may apply through the application system. We regret to inform only Shortlisted candidates will be notified.

EA License No. 01C4394 • RCB No. 200007268E •Derrick Tiew Yong Han EA Registration No. R1877971

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Motivated by the vision to improve the quality of people’s lives, WS Audiology continues to grow as the market leader in the hearing aid industry. With our commitment to increase penetration in an underserved hearing care market, we want to accelerate our business transformation to reach more people, more effectively.

With our commitment to delivering a better transportation experience, we are looking for a Senior Specialist, APAC Trade Compliance and Transportation to work with internal & external stakeholders on optimizing the transportation network between our APAC production plants.

What you will do

• Coordinate the APAC transportation network between the three main APAC production plants (Singapore, Philippines, and China) and the main distribution centers and country warehouses.
• Manage carriers at an international level, including express couriers and freight forwarders. This involves handling business relations, performance evaluations, and cost reviews.
• Create and support freight optimization projects for the APAC region.
• Oversee daily tasks related to freight monitoring and customs clearance at the distribution site in Singapore.
• Implement a trade compliance program and conduct periodic audits on trade compliance matters.

What you bring

• At least 5 years of operational experience in international transportation, preferably in a parcel environment.
• Proficiency in carrier management, including conducting reviews and coordinating daily operations.
• Advanced Excel skills, including pivot tables and VLOOKUP. Proven history of delivering transportation network optimization projects (cost, performance, etc.).
• A broader understanding of related supply chain processes (warehouse, purchasing, etc.) is advantageous.
• Advanced communication, interpersonal, and intercultural skills for working with global stakeholders.

Who we are

At WS Audiology, we provide innovative hearing aids and hearing health services.

Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world.

With us, you will become part of a truly global company where we support one another, welcome diversity and celebrate our successes.

Sounds wonderful? We can't wait to hear from you.

WS Audiology is an equal-opportunity employer and committed to creating an inclusive employee experience for all. Regardless of race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, disability, military or veteran status we firmly believe that our work is at its best when everyone feels free to be their most authentic self.

The Quality Assurance Specialist is responsible to:
- Maintain and ensure effectiveness of the Quality Management System in Singapore,
- Perform product complaints handling for Singapore,
- Perform Adverse Events reporting to local regulatory authorities of Singapore,
- Perform Field Safety Corrective Actions and reporting for Singapore.

Responsibilities:

• Quality Assurance for all aspects of the Quality Management System (QMS) of Singapore Distribution Centre (DC), including maintenance, continued compliance, and certification.
• Ensure quality and regulatory compliance to relevant applicable standards such as GDPMDS (Singapore)

• Be responsible for operational quality matters including product hold in Singapore.

• Act as the Complaints Handling unit for Singapore.
• Conduct training of staff in QMS to ensure relevant staff are trained to the latest revision of procedures.

• To perform assessment and adverse event reporting to local authorities of Singapore.
• Execute Field Safety Corrective Actions (FSCA) in Singapore, including reporting to local authorities.

• Manage outsourced activities to ensure vendors meet the Cook Medical's quality standards.

• Coordinate or investigate CAPA to ensure nonconformances are addressed effectively.

• Schedule and perform internal audits. Host or support external audits.

• Perform trending and produce metrics for DC performance, measuring against key performance indicators.

• Maintain up-to-date knowledge and compliance with Global policies and procedures and to implement locally.

• Participate in global projects and meetings if applicable.

• Act as the local contact person for Data Protection facilitation.

• Perform other tasks assigned by Manager.

• Have a sound understanding of, and comply with, the COOK Code of Conduct and Company Compliance requirements.

Requirements:

• At least 3 years working experience as quality assurance in the medical device field.

• Degree in Science, Engineering or other related discipline.
• Experience in adverse event assessment and reporting for Singapore.
• Experience in Field Safety Corrective Action execution and reporting for Singapore.
• Experience in multinational medical device company preferred.

• Excellent communication and interpersonal skills, able to work with people from different levels internally and externally.
• Excellent time management and organizational skills. Able to perform duties with limited supervision and meet deadline.

• Fluent in English (both spoken and written).
• Skilled in document management.
• High level of computer skills including Microsoft Office.
• Multi-tasks and able to prioritize the job tasks, depending on the urgency.
• Positive attitude, be good team player and attend to details.