Job Info:

• Salary: Basic up to $4000 + AWS + VB
• Working Hour: Monday - Friday (7.50am - 4.55pm)
• Location: Joo Koon

Job Scope:

• Plan, supervise, and execute projects and tasks
• Address and prevent issues to enhance customer satisfaction regarding product quality
• Maintain quality, environmental, and water efficiency systems within the company
• Assist in the maintenance and compliance of ISO 9001, ISO 14001, IATF 16949, ISO 17025, ISO 13485, and ISO 46001 standards
• Understand the company's policies and objectives related to quality, environment, water efficiency, and occupational health and safety (OH&S), as well as environmental aspects, safety risk assessments, and information security risks
• Conduct internal Quality and Environmental Management System (QEMS and WEMS) audits and coordinate external audits
• Monitor quality failure costs in the production department
• Perform calibration and maintenance of x-ray machines, ensure cleanliness in the x-ray equipment area, and update monthly schedules for x-ray machine maintenance

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*We regret to inform you that only shortlisted candidates would be notified*

We wish you all the best in your career search.

You are welcome to visit our website at http://www.rkgroup.sg/

RK Recruitment Pte Ltd | EA License No.: 20C0280

Chou Jia Hooi | EA Personnel No.: R23115147

About the Role

As a Quality Control Inspector, you'll be reporting to an Operations Manager and working as a part of our Operations team. At QIMA, the role of Operations is to deliver our industry-leading services to our clients while ensuring that all the work is performed to the QIMA standard of quality. Your role in this will be to:

• Check email daily in order to receive inspection documents and guidelines;
• Attend inspections on time and communicate with supplier in a professional way;
• Perform the inspection of the merchandise according with company procedures. Supervise the stuffing of the containers according with company procedures;
• Fulfill inspection reports according with company procedures and time lines.

Job Description

• Assists Assistant Section Manager with the daily NDT Inspection activities and manpower deployment
• Reviews technical specifications, drawings, procedures, and standards required in the project
• Reviews and checks the project NDT plan and procedures submitted by NDT Assistant Engineer/ Engineer
• Monitors the project schedule for NDT activities
• Reviews and monitors NDT contractors' technicians’ list, equipment calibration list, and their NDT reports before submission to project clients
• Performs dressings, electrocardiograms, and other minor procedures
• Liaises with QA Engineers on the NDT work scope, requirements, and progress
• Ensures there is proper documentation of project inspection and test activities
• Initiates recommendations and provides solutions to project problems through designated channels
• Performs internal audits on project documents and inspection activities
• Ensures that all standard operating procedures comply with specifications, quality standards, statutory and regulatory requirements
• Any other assigned duties and responsibilities

Job Requirements

• Degree/ Diploma in Naval Architecture/ Civil/ Marine and Offshore Engineering/ Mechanical Engineering
• At least 3 years of relevant Quality Assurance working in Radiography and Ultrasonic Flaw Detection Test, preferably in the offshore and marine industry
• Possess a positive and willing-to-learn attitude

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. Support and / or perform maintenance / calibration of laboratory equipment in compliance with established schedules.
4. Liaise with vendors/service providers for PM / Calibration in a timely manner.
5. Responsible for maintenance / calibration planning of equipment within QC Department.
6. Ensure real time documentation, maintain data integrity and appropriate traceability.
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.

Job Description & Requirements

Able to operate CNC CMM machine with 2 years experience needed is a priority.

Knowledge in QC equipments, example: Height Gauge, Smart Scope, Veriner caliper etc.

With computor knowledge to provide QC report and handle NCR.

Must have knowledge in drawing specification. Example: Tolerance, Surface Treat, Heat Treat etc.

Basic knowledge in machining process.

Dear all

One of our Oil and gas Industry client is looking for their workshop as a Quality Engineer. Person education should be in Bachelor Degree with min 5 years of relevant working Experience

Responsibilities:

• Monitor operations to ensure that they meet production standards.
• Recommend adjustments to the assembly or production process.
• Inspect, test, or measure materials.
• Measure products with calipers, gauges, or micrometers.
• process control, control charts, acceptance sampling, and product quality control
• Must know about the CNC machines, and knowledge in Programming.

Office Location: 
Pioneer Turn (Jurong)

Opportunities & Exposure

1. Drive process optimization in Claims Management

• Perform UAT (User Acceptance Test) on the evolution/ enhancement of a newly developed online tool
• Enhance communication & marketing of new tool - Support roll-out of tool to new sites within APAC
• Provide training to internal & external teams within APAC
• Identify improvement areas and develop an action plan with the project committee to reduce claims

2. Drive improvement in data quality management

• Participate in evidence gathering and root cause determination to secure the quality process in our logistics partner (Bollore) to fulfill customers’ expectation
• Perform thorough quality analysis to measure the effectiveness of various quality processes using data and internal auditing tools
• Initiate corrective actions for procedural or process deficiencies
• Develop common tools to facilitate weekly performance tracking/ reporting and follow-up of KPIs and action plan

Responsibilities:

• Lead and manage the food safety and quality team to ensure compliance with food safety standards and regulations.
• Develop and implement food safety and quality policies, procedures, and guidelines.
• Conduct regular inspections and audits to ensure adherence to food safety protocols.
• Monitor and analyze quality data to identify trends and areas for improvement.
• Collaborate with cross-functional teams to address quality issues and implement corrective actions.
• Manage and maintain the company's food safety and quality management system.
• Develop and deliver training programs on food safety and quality control.
• Conduct internal audits to evaluate the effectiveness of food safety and quality systems.
• Ensure compliance with regulatory requirements and industry standards.
• Stay updated on industry best practices and advancements in food safety and quality management.

• Bachelor's degree in Food Science, Nutrition, or related field.
• Minimum 5 years of experience in food safety and quality management roles.
• Strong knowledge of food safety regulations and standards.
• Experience with food safety and quality management systems.
• Certification in Food Safety (e.g., HACCP, GMP) is highly desirable.
• Excellent leadership and team management skills.
• Strong analytical and problem-solving abilities.
• Excellent communication and interpersonal skills.
• Ability to work cross-functionally and collaborate effectively with teams.

Interested candidates who wish to apply for the advertised position, please send in your resume to [email protected].

EA License No: 13C6305

Reg. No.: R1654399

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:

• Support continuous improvement efforts in QMS.
• Support in root cause analysis and implementation of corrective/ preventive actions for process related concerns.
• Analyze and provide timely respond to customer complaints.
• Interface with Customer and Operations to ensure new product transfer to manufacturing are in accordance with approved requirements.
• Prepare Quality performance metrics and reports.

Requirements:

• Diploma in Mechanical Engineering, Quality, or equivalent.
• Minimum 2 years work experience in Quality Management System in manufacturing environment.
• Good knowledge of ISO 9001. Knowledge of API Q1 is preferred.
• Strong command of English language, both oral & writing.
• Knowledge of metal working industry is preferred.
• Knowledge of risk assessment principles and methods.
• Knowledge of SAP is preferred.
• Positive & proactive attitude.

About Us:

JSTT Singapore Pte Ltd is a leading producer of high-quality sushi and sashimi, providing fresh and delicious products to supermarket counters across [specific regions]. Committed to excellence, we are seeking a skilled and dedicated professional to join our team as a Food Safety and Quality Assurance Officer.

Responsibilities:

As the Food Safety and Quality Assurance Officer, you will be responsible for ensuring the highest standards of food safety, quality, and compliance with ISO22000 and FSSC regulations in our central kitchen and 20 supermarket counters. Your key responsibilities include:

1. Compliance Management:

• Oversee and implement food safety and quality management systems in accordance with ISO22000 and FSSC standards.
• Conduct regular audits and inspections to ensure compliance with all relevant regulations and internal standards.

2. Documentation and Reporting:

• Maintain accurate records of all food safety and quality assurance activities.
• Prepare comprehensive reports for management, summarizing key performance indicators and areas for improvement.

3. Training and Development:

• Develop and deliver training programs for staff at the central kitchen and supermarket counters on food safety protocols and best practices.
• Keep the team informed about updates in food safety regulations and industry trends.

4. Incident Response:

• Establish and implement effective procedures for handling food safety incidents and recalls.
• Conduct thorough investigations into any breaches of food safety standards and recommend corrective actions.

5. Supplier and Vendor Management:

• Collaborate with suppliers and vendors to ensure the quality and safety of raw materials used in our production processes.
• Evaluate and approve suppliers based on established criteria.

Qualifications:

• Certification in ISO22000 / FSSC standards.
• Proven experience in food safety and quality assurance, preferably in the sushi and sashimi production industry.
• Strong knowledge of local and international food safety regulations.
• Excellent communication and training skills.

Job Responsibilities:

• Support continuous improvement efforts in QMS.
• Support in root cause analysis and implementation of corrective/ preventive actions for process related concerns.
• Analyze and provide timely respond to customer complaints.
• Interface with Customer and Operations to ensure new product transfer to manufacturing are in accordance with approved requirements.
• Prepare Quality performance metrics and reports.

Requirements:

• Diploma in Mechanical Engineering, Quality, or equivalent.
• Minimum 2 years work experience in Quality Management System in manufacturing environment.
• Good knowledge of ISO 9001. Knowledge of API Q1 is preferred.
• Strong command of English language, both oral & writing.
• Knowledge of metal working industry is preferred.
• Knowledge of risk assessment principles and methods.
• Knowledge of SAP is preferred.
• Positive & proactive attitude.

Job Responsibilities:

• Support continuous improvement efforts in QMS.
• Support in root cause analysis and implementation of corrective/ preventive actions for process related concerns.
• Analyze and provide timely respond to customer complaints.
• Interface with Customer and Operations to ensure new product transfer to manufacturing are in accordance with approved requirements.
• Prepare Quality performance metrics and reports.

Requirements:

• Diploma in Mechanical Engineering, Quality, or equivalent.
• Minimum 2 years work experience in Quality Management System in manufacturing environment.
• Good knowledge of ISO 9001. Knowledge of API Q1 is preferred.
• Strong command of English language, both oral & writing.
• Knowledge of metal working industry is preferred.
• Knowledge of risk assessment principles and methods.
• Knowledge of SAP is preferred.
• Positive & proactive attitude.

Job Responsibilities:

• Support continuous improvement efforts in QMS.
• Support in root cause analysis and implementation of corrective/ preventive actions for process related concerns.
• Analyze and provide timely respond to customer complaints.
• Interface with Customer and Operations to ensure new product transfer to manufacturing are in accordance with approved requirements.
• Prepare Quality performance metrics and reports.

Requirements:

• Diploma in Mechanical Engineering, Quality, or equivalent.
• Minimum 2 years work experience in Quality Management System in manufacturing environment.
• Good knowledge of ISO 9001. Knowledge of API Q1 is preferred.
• Strong command of English language, both oral & writing.
• Knowledge of metal working industry is preferred.
• Knowledge of risk assessment principles and methods.
• Knowledge of SAP is preferred.
• Positive & proactive attitude.

Responsibilities:

• Focus on EASA and CAAS main changes under Direction of ARU Quality Manager to update when necessary.
• Perform internal audits as per internal audit schedule in accordance AS9110C and P-145 requirements
• Support external audits, (Civil Aviation Authorities, customers and Certification bodies)
• Manage and update Quality procedures in the Quality Management System.
• Conducts trainings on quality subjects to staff to enhance understanding of subject as per training plan
• Ensure internal production quarantine item are managed timely and accurately
• Validate the qualification of new test equipment, Qualification of New Repair Capability & Qualification of New Test Bench
• Supporting India MRO Project Phase

Requirements:

• Min. Degree/ Diploma in Quality, Quality Management, Engineering or Equivalent
• Experienced in Avionics Workshop Maintenance Environment/ Electronics Workshop / Mechanical Workshop
• Experienced in Quality Auditing
• Experienced in Procedural and Process developments
• Knowledge in: AS9110C (ARU) & PART-145 (ARU)

Other Information:

• Working location: Changi
• Working hours: Monday - Friday, 9am - 6pm
• Company transport provided at designated MRT stations
• 1 Year Contract position

(Key Roles)

1 Customer & field return complaints handling & resolution.

Drive for timely identification of root cause and corrective actions plans. Monitor track the effectiveness of corrective action implemented. Internalize and deploy warranty field failure DPPM metrics with alignment to key process improvement including manufacturing, test and development processes

2 Drive subcontractors together with Quality members to build quality into the products through

a) Audits

b) Ensuring system and processes are in placed including but not limited to establishment of critical processes.

c) Deploy effective quality methods and tools across subcon processes

3 Perform evaluations & tests to assess and mitigate risk on Quality issues

4 Participate in new project reviews during development stages and assess product risk

5 Any other Adhoc projects as assigned

(Secondary Roles)

1. Monitor performance of new product quality during development and initial mass production stage

2 Assess new product risk before mass production and readiness of product

3 Review Critical Parts list and Quality plan

4 Conduct periodic team meetings both internal and or subcontractors to align with QA process and address issues with QA tools quality issues & corrective action closure.

5 Set & monitor factories KPIs through quality performance, quality management

6 Conduct system and process audits

7 Work with Subcon to ensure their key suppliers are in compliance of supplied materials

Main Responsibilities:

• Preparation of routine QC samples for instrumental analysis and sensory evaluation
• Perform olfactive assessment of QC materials
• Results entry into SAP and other ERP
• Creation of material specifications
• Inventory management of laboratory consumables
• Basic maintenance of laboratory equipment and general housekeeping (5S)
• Conduct trials and prepare reports/results from trial for review by seniors/manager
• Support laboratory supervisors in analysis of results and CAPA

Job Requirements:

• Diploma in Chemical Process Technology or Perfumery and Cosmetic Science
• 2 years of plant QC experience and preferably in chemical manufacturing or related industry
• Basic sensory evaluation skills and chemical knowledge
• Team player and good interpersonal skills

Sunningdale Tech Ltd is a leading manufacturer of precision plastic components. The Group provides one-stop, turnkey plastic solutions, with capabilities ranging from product & mould designs, mould fabrication, injection moulding, complementary finishings, through to the precision assembly of complete products.

Boasting a total factory space of more than 4 million sq feet, with more than 1,000 injection moulding machines and a tooling capacity of 2,000 moulds per year, Sunningdale Tech is focusing on serving four key business segments – Automotive/Aerospace, Consumer/IT, Healthcare and Tooling.

With manufacturing facilities across Singapore, Malaysia (Johor, Penang), China (Tianjin, Shanghai, Suzhou, Zhongshan, Guangzhou, and Chuzhou), Latvia (Riga), Mexico (Guadalajara), North America (Phoenix), India (Chennai), Thailand (Rayong), and Indonesia (Batam), Sunningdale Tech is strategically positioned to target and capture opportunities in diverse business sectors globally.

As an industry leader with deep engineering expertise and experience, Sunningdale Tech is driven to solve your challenges by applying our advanced capabilities & leading technology in ways that benefit you. We’re ready to provide solutions at every step of the process to reduce lead time and add value for customers, while maintaining our excellent quality. Beyond that, we build on our strong foundations to think out of the box and apply relevant new possibilities for your complex engineering problems. Customers can trust us to constantly solve challenges to meet their needs, and apply new ideas for better outcomes.

Responsibilities:

• Resolves customer inquiries, quality, and operational issues in a timely manner by consulting with the Business Development HOD, Operation Manager, QA Manager, other supporting managers, Superior
• Manage, lead, and motivate a team of quality inspectors and technicians to meet departmental objectives and goals, create and promote food safety, GDP, GMP & lead by example
• Early involvement in new product and project development to establish internal specification and keep abreast of customer requirements
• Document in STL’s quality system and implement programs to ensure compliance with applicable regulatory requirements and corporate’s quality system requirements
• Develop and continually improve production, inspection and process control activities, corrective & preventive action, hazard analysis and risk management
• Responsible for timely closure of CAPA, non-conformance investigation report, customer complaints and deviations. Escalate to superior if required
• Analyse and trend various Key Performance Indicators per management’s vision and direction, including indicator of interest
• Develop, reviews, and approves qualifications and validation protocols, involvement in food Hazard/Medical device Risk management activities and departmental level risk and opportunity assessment, including JSA
• Ensures effective communication internally & externally
• Ensure department’s personnel competency, develop, and retain skill base knowledge within the organisation, through training needs identification
• Any other duties as and when assigned
• Take reasonable care of workplace health and safety; abide by all EHS policies and procedures; cooperate with Management and colleagues in EHS initiatives

Requirements:

• Diploma and / or Bachelor Degree in Biomedical Engineering
• Minimum 2 year's experience in QA function, preferably in plastic injection molding company
• Strong knowledge of Quality tools and Quality concept fundamentals
• Ability to perform root cause analysis, process optimization, data analysis and validation effectively manage a high-volume manufacturing setting/environment
• Ability to apply problem solving technique and provide solutions under minimal supervision.
• Good written and oral communication skills
• Training and developing both technical and non-technical employees
• Prior supervisor experience managing several direct reports

The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all of the specific requirements of the job. These job duties/responsibilities may change or vary in response to business needs.

Only shortlisted candidates will be notified

Sunningdale Tech is an equal opportunity employer – we believe that a diverse and inclusive workforce will cultivate a vibrant, productive and innovative workplace where all employees are truly respected and valued.

All qualified applicants shall be considered for employment regardless of age, race, gender, gender identity, religion, marital status, medical condition, mental or physical disability, national origin, political and/or third party affiliation or veteran status. All offers of employment shall be conditioned upon successful completion of background checks, valid work passes and medical screenings, as applicable and/or mandated by law, and subject to the applicable local laws and regulations.

Job Responsibilities:

• Support continuous improvement efforts in QMS.
• Support in root cause analysis and implementation of corrective/ preventive actions for process related concerns.
• Analyze and provide timely respond to customer complaints.
• Interface with Customer and Operations to ensure new product transfer to manufacturing are in accordance with approved requirements.
• Prepare Quality performance metrics and reports.

Requirements:

• Diploma in Mechanical Engineering, Quality, or equivalent.
• Minimum 2 years work experience in Quality Management System in manufacturing environment.
• Good knowledge of ISO 9001. Knowledge of API Q1 is preferred.
• Strong command of English language, both oral & writing.
• Knowledge of metal working industry is preferred.
• Knowledge of risk assessment principles and methods.
• Knowledge of SAP is preferred.
• Positive & proactive attitude.

Job Responsibilities:

• Support continuous improvement efforts in QMS.
• Support in root cause analysis and implementation of corrective/ preventive actions for process related concerns.
• Analyze and provide timely respond to customer complaints.
• Interface with Customer and Operations to ensure new product transfer to manufacturing are in accordance with approved requirements.
• Prepare Quality performance metrics and reports.

Requirements:

• Diploma in Mechanical Engineering, Quality, or equivalent.
• Minimum 2 years work experience in Quality Management System in manufacturing environment.
• Good knowledge of ISO 9001. Knowledge of API Q1 is preferred.
• Strong command of English language, both oral & writing.
• Knowledge of metal working industry is preferred.
• Knowledge of risk assessment principles and methods.
• Knowledge of SAP is preferred.
• Positive & proactive attitude.

Activate Interactive Pte Ltd (“Activate”) is a leading technology consultancy headquartered in Singapore with a presence in Malaysia and Indonesia. Our clients are empowered with quality, cost-effective, and impactful end-to-end application development, like mobile and web applications, and cloud technology that remove technology roadblocks and increase their business efficiency.

We believe in positively impacting the lives of people around us and the environment we live in through the use of technology. Hence, we are committed to providing a conducive environment for all employees to realise their full potential, who in turn have the opportunity to continuously drive innovation.

We are searching for our next team members to join our growing team.

If you love the idea of being part of a growing company with exciting prospects in mobile and web technologies that create positive impact on people’s lives, then we would love to hear from you.

Health & Co-Development Business Unit is looking for Software Quality Engineer

Internal Code: A24024

What will you do?

• Create and maintain test cases, test plans and test reports to ensure they are up to date with project and security requirements
• Conduct testing on new features and file defects
• Perform various tests such as manual, functional, performance, exploratory tests, UAT
• Assist in resolving issues during testing and production stages
• Coordinate with in-house development team, vendors, and users to conduct tests such as User Acceptance test, systems integration tests and performance tests.
• Drive adoption of relevant, up-to-date technologies, practices and tools in Agile software projects
• Contribute in technical discussions and solutioning sessions
• Maintain the Quality Standards of the software at every stage.
• Execute both manual and automated test scripts

What are we looking for?

• Degree in software engineering, computer engineering, electrical engineering or infocomm-related discipline.
• At least 3 – 5 years of professional experience in software quality testing
• Understanding of testing techniques, test-driven development, continuous integration and continuous delivery
• Experience with open source automated testing frameworks (preferably Cypress) and open source performance testing tools (e.g. k6) is preferred
• Experience in Agile development teams, employing relevant methodologies and practices such as Scrum
• Keen to share knowledge with team mates and mentor fellow developers
• Good communication and interpersonal skills
• Self-driven and independent

What do we offer in return?

• Fun working environment
• Employee Wellness Program

Does it sound like something you are interested in exploring further? Please be in touch with our team for an initial chat at [email protected]

Activate Interactive Singapore is an equal opportunity employer. Employment decisions will be based on merit, qualifications and abilities. Activate Interactive Pte Ltd does not discriminate in employment opportunities or practices on the basis of race, colour, religion, gender, sexuality, national origin, age, disability, marital status or any other characteristics protected by law.

Protecting your privacy and the security of your data are longstanding top priorities for Activate Interactive Pte Ltd.

Your personal data will be processed for the purposes of managing Activate Interactive Pte Ltd’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results, and as is otherwise needed in the recruitment and hiring processes.

Please consult our Privacy Notice (https://www.activate.sg/privacy-policy) to know more about how we collect, use, and transfer the personal data of our candidates. Here you can find how you can request for access, correction and/or withdrawal of your Personal Data.

Primary Function:

• Ensure that change control and validation activities are executed in a timely manner.

Key Responsibilities:

• Develop, execute and review validation protocols and related documentation in accordance with procedures and policies
• Support Failure Mode Effects Analysis (FMEA) for new installations or changes.
• Manage change control documentation in respective data management systems
• Perform root cause analysis and identify corrective and preventive actions in addressing quality events
• Support resolution of validation events and escalate concerns in a timely manner
• Support in equipment and process walkdowns
• Weekly, Monthly and Quarterly reporting as required for own business area
• Develop and execute business area improvement projects
• Develop training materials and conduct training
• Participate in internal and external audits
• Participate in division and site projects, improvement activities and technical sharing platforms
• Comply to all policies and standards
• Any other ad-hoc requests as assigned by the supervisor

Requirements:

• Bachelor's Degree in a Science or Engineering discipline
• Min 3 years of related experience in change control and validation in a manufacturing plant required, preferably in Food/Nutrition/Pharma industry
• Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Familiarity in developing SOPs and work flows
• Knowledge of problem-solving tools (e.g. 6M Analysis, Fishbone, 5 Whys, etc.).
• Familiarity with international and technical standards is a plus (ISO, FSSC etc)
• Proficient in Microsoft applications (Powerpoint, Word, Excel)
• Team player with initiative, drive, good communication skills and a strong command of written English
• Ability to think systematically and with analytical mindset
• Ability to do data analysis using Minitab, JMP is a plus
• Experience in manufacturing process design and equipment design or application is a plus

*Kindly note this position is based in Tuas.

Main Duties and Responsibilities

· Accountable for qualification of suppliers and co-packers prior to supplying, include activities of document review, supplier liaison and technical review, audits until approval.

· Manage supplier / co-packer audit, end to end co-packer assessment; i.e. conduct audit, provide timely updates on audit status and findings; and monitor co-packer performance post qualification, for full approval

· Responsible for qualification and validation of new lines, new processes and change of equipment. It involves sterility test plan designing and execution; CIP and Hygiene verification to meet F&N requirements before line approval for commercial runs.

· Responsible for qualification of new or alternative raw material, to ensure meeting to F&N food safety, regulatory and documentation requirement.

· To support to manage Quality Plan program for all Business Units, coordinate and engage business unit key stakeholders to review / maintain Quality Plans

· To support in collate and analyze Business units’ performance on food safety and quality compliance, product customer complaint trends and key risk indicators of Business units.

· Responsible for GTQM centralized shared point database, acts as database leader / power user trainer, to keep documents are updated / maintained for Group R&D and BUs reference. Support in Group R&D and Business units user access request processing and user access approval matrix maintenance.

· Act as GTQM Document Controller, ensure document master lists are maintained and updated, initiate documentation development / revision, to ensure document is updated to meet F&N standards and requirements

· Technical support Business units to drive continuous improvement, initiate positive change to deliver an efficient and value-adding process, conduct training or site visit if need to.

· Support to initiate the development and governance of corporate policies, guidelines, procedures.

· Assist in troubleshooting e.g. Quality/ process/ system issues as required

Requirements:

- Min. Degree in any field

- At least 5 years of relevant experience in the similar industry

- Able to work in fast-paced environment

Job Responsibilities:

• Support continuous improvement efforts in QMS.
• Support in root cause analysis and implementation of corrective/ preventive actions for process related concerns.
• Analyze and provide timely respond to customer complaints.
• Interface with Customer and Operations to ensure new product transfer to manufacturing are in accordance with approved requirements.
• Prepare Quality performance metrics and reports.

Requirements:

• Diploma in Mechanical Engineering, Quality, or equivalent.
• Minimum 2 years work experience in Quality Management System in manufacturing environment.
• Good knowledge of ISO 9001. Knowledge of API Q1 is preferred.
• Strong command of English language, both oral & writing.
• Knowledge of metal working industry is preferred.
• Knowledge of risk assessment principles and methods.
• Knowledge of SAP is preferred.
• Positive & proactive attitude.

Mission

Sanofi is preparing its future through an ambitious program named EVolutive Facility (EVF). The EVF Project is at the cornerstone of Sanofi Pasteur strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable and agile, leveraging new disruptive technologies, to better address vaccine business challenges. Digital will be one of the key topics to help EVF to reach its ambition. On top of it, Sanofi is also embarked with the ambition to leapfrog the competition through a digital acceleration program with the following vision: “Sanofi will fully integrate Digital capabilities & culture within its operations to boost business growth and profitability in 2025+”.

In this context, we are looking for Specialist II, Quality Operations for our new site based in Singapore.

Key Accountabilities

The mission described below, must be exercised in compliance with health, safety and environment of the site rules.

The Specialist II, Quality Operations will be responsible to partner with the GMP operations team to provide Quality oversight and advice for Quality on-the-floor and operations support to ensure the EVF Singapore GMP Quality operations meets Sanofi global Quality standard requirements and fulfil the applicable regulatory expectations. The Specialist II, Quality Operations shall be experienced in solving complex problems, and strong understanding of cGMP operations and well-versed in multiple Quality systems (including exception management, change controls, deviations/CAPAs and document management system).

The incumbent will partner closely with operational teams (e.g. manufacturing, facilities, Quality control and technical units) to ensure Quality, safety, reliability, efficiencies to support EVF Singapore GMP manufacturing operations.

During the Project Phase, the Specialist II, Quality Operations will participate in the following Engineering / Commissioning & Qualification activities:

Engineering / Commissioning & Qualification activities:

• Review and approval of engineering documents related to GMP operations.
• Support and provide inputs to Installation, Operational Qualification (IOQ) activities for equipment used in GMP operations.
• Review and approval of operational, as well as process related documents (e.g. work instructions, SOPs, batch records).
• Support the digital and automation infrastructure setup including Delta V recipe, MES workflows, other process equipment related systems, ERP module setup, etc.
• Ensure that Quality related operational procedures and infrastructures are successfully implemented in preparation for Engineering runs and PPQ runs at the EVF Singapore Site to support site operational readiness and success.

Provide GMP Quality support during PPQ runs:

• Responsible to provide direct solid Quality advice to GMP operational teams to ensure compliance, reliability and efficiencies.
• Responsible to provide direct QA oversight for all GMP operations (including on-the-floor Quality oversight, raw materials release, deviations, change controls and CAPAs) at EVF Singapore manufacturing facility.
• Represent Quality to triage, resolve on-the-floor operations issues, and participate in root cause investigations.
• Escalate significant Quality issues to Quality management in a timely manner.
• Champion Quality within the Operations team to establish an engrained Quality culture across the organization.

Working hours –

• Personnel shall be able to work office hours (weekdays) in Sanofi Site Office to support collaborations and meetings with stakeholders leading up to Engineering runs.
• Personnel shall be able to work 12 hours rotating shift (including day/night, and weekends) on site to support PPQ runs and Engineering runs, as required.
• Work from Home (hybrid) arrangements are subjected to discussion with Function Manager during the Project Phase.

During  Routine Operations, the Specialist II, Quality Operations shall:

• Be responsible to provide direct solid Quality advice to GMP operational teams to ensure compliance, reliability and efficiencies.
• Be accountable to ensure that Quality related operational procedures and infrastructures are successfully implemented to support EVF Singapore site operational and inspection readiness and success.
• Be responsible to provide direct QA oversight for all GMP operations (including on-the-floor Quality oversight, raw materials release, deviations, change controls and CAPAs) at EVF Singapore manufacturing facility.
• Represent Quality to triage, resolve on-the-floor operations issues, and participate in root cause investigations.
• Escalate significant Quality issues to Quality management in a timely manner.
• Champion Quality within the Operations team to establish an engrained Quality culture across the organization.
• Lead and support the site driven QA continuous improvement initiatives/activities during the routine operational phase.
• Participate in regulatory inspections and interact directly with regulatory inspectors (as applicable).
• Lead and support QA Operations related trainings and coaching for the Quality organization.
• Contribute to reach the EVF Quality manufacturing 4.0 ambition through a Quality plan.

Working hours –

• Personnel must be able to work 12 hours rotating shift (including day/night, and weekends) on site to support production activities.

Education and experience

• Bachelor’s or Master’s Degree in Sciences, engineering or other related technical field.
• Minimum of 5 years of relevant experiences preferably in Manufacturing, Validation, Engineering, Quality in the pharmaceutical or biotechnology industry (preferably in vaccines and/or biologics).

Key technical competencies and soft skills:

• Manufacturing 4.0 mindset (such as Agile methodology)
• Expert Knowledge of regulations and standards of the pharmaceutical industry, Global Quality policies and Data Integrity Requirements.
• Solid manufacturing process technical knowledge.
• Broad understanding of QA Operations (from an end-to-end perspective).
• Strong interpersonal skills to establish the partnerships necessary for the development of an engrained Quality culture and the correct execution in transverse.
• Ability to work independently and make quick, effective decisions under pressure.
• Discipline and assertiveness in the decision-making and execution of digital manufacturing strategy.
• Familiarity with electronic batch record (MES) and related review processes.
• Familiarity with batch release and disposition process, preferably using the SAP system.
• Proficient in QMS and Quality Risk Management Principles.
• Excellent verbal and written communication skills; effective communication and presentation skills across different levels of the organization, including senior management and execution levels.
• Experience in facility start-ups will be advantageous.
• Good understanding of risk-based decision framework.
• Familiar with Digital 4.0 concepts and potential applications in Quality.

Job Responsibilities

• Software design and optimization, focusing on coding and debugging
• To design, develop, and maintenance of iPhone Apps
• Maintain existing mobile apps on the IOS platform
• Troubleshoot and debug to optimize performance
• Knowledge of Java, Kotlin, MSSQL, and C#
• Develop application programming interfaces (APIs) to support mobile functionality
• Use and adapt existing web applications for apps
• Troubleshoot and debug to optimize performance
• Design interfaces to improve user experience
• Ensure all developments are of high quality and comply with the required specifications
• Stay up-to-date with the technology trends, security and data protection, concepts and best practices for coding mobile apps

Job Requirements

• Candidates must possess at least a Diploma/ Degree in Information Technology/ Computer Science/ Computer Engineering
• hands-on proficiency in iOS app development
• Familiar with Mobile Application Development life cycle
• Demonstrable portfolio of released applications on the App store market
• Good interpersonal and communication skills in English
• Excellent project and time management skills
• Patient, polite, friendly and helpful personality
• Creative and able to work independently and as team in a stimulating multi-disciplinary environment emphasizing team work
• Able to cope with fast paced-environment
• Experience in web application development is an added advantage