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

• Carry out troubleshooting and corrective action of instrument breakdown or failures to find out the root cause and best solution in order to restore the functionality get back to normal
• Respond to technical queries from operation personnel and provide advice/solution according to best engineering practice to address issues which affect the operation of the power plant
• Follow C&I work instructions and propose changes for improvement where necessary
• Lead the execution of shutdown works for instrumentation to ensure completion of shutdown work on time
• Work closely with various sections to coordinate cross-functional maintenance works
• Perform risk assessment prior to start of work and conduct on-job risk assessment to identify residual risks associated with the planned/unplanned work
• Monitor spare parts and inventory for critical instrumentation to ensure availability when required in order to minimize unplanned outages. Establish new inventory/cataloging where necessary. Update information in the inventory to ensure that it is relevant for the current operation.
• Provide technical inputs in full cycle of procurement processes for materials and service requisition where required so that all technical requirements are addressed properly to protect company’s interest
• Identify, study, propose, and implement area for improvement in the field of instrumentation engineering to enhance operation and improve overall equipment reliability
• Supervise on-site contractors/additional supplier’s C&I technician(s) as well as C&I vendors to perform site works, review their work procedures and instructions to ensure compliance to achieve highest quality of work in a safe manner
• Participate actively in any meeting, discussion and initiative by team which is relevant to the job role and business needs in order to safeguard company’s interest
• Populate inputs into the Computerized Materials and Maintenance Management System (CMMS) to ensure data and history of equipment maintenance activities are captured accurately. Provide inputs to Planning Engineer with regard to instrument maintenance activities for consolidation

Job Requirements

• Possess a degree in Instrumentation and Control Engineering or Electronics and Electrical Engineering with at least three (3) years of working experience in the instrumentation field, or a diploma in the same fields with at least seven (7) years of working experience in instrumentation field
• Proficient in the codes and standards in the power plant industry i.e. BSI, ISO27001, ANSI, IEC, IEEE, etc.
• Strong interpersonal skills, a team player and able to work with all levels of management and multinational staff
• Hands-on experience in field instrumentation and sensors of different makes
• Proficient in power plant DCS and HMI systems, specifically experience with ABB Advant DCS, GE Alspa DCS will be an advantage
• Proficient in any power plant PLC control system
• Proficient in the P&ID, loop diagram, process functional flow diagram and familiar with gas turbine / steam turbine operations and protection concepts
• Cyber security knowledge in Operation Technology will be an added advantage

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.

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.

(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

The eVTOL Research and Innovation Centre at School of Mechanical & Aerospace Engineering (MAE), Nanyang Technological University, Singapore, is looking for a strong candidate as Senior Research Engineer I in the area of Flight Control System.

Key Responsibilities:

• Design, development, and integration of avionics systems for advanced eVTOL project, ensuring seamless integration of avionics components with other aircraft systems.
• Oversee the design and development of avionics hardware, including sensor integration and communication interface control.
• Design a new ground station together with the supplier to operate the eVTOL
• Manage software development for avionics systems, ensuring compliance with safety and performance standards.
• Develop and implement a testing plan to verify the functionality and reliability of avionics systems.
• Conduct system testing, and troubleshooting, and participate in flight testing as needed.
• Prepare and maintain comprehensive documentation, including technical specifications, test plans, test reports and operation manual.
• Manage suppliers, and communicate project status and technical information to both technical and non-technical stakeholders.

Job Requirements:

• Bachelor’s or master’s degree or Ph.D in aerospace engineering, Electrical Engineering, or a related field.
• Minimum 3 years experience in designing and implementing flight control systems for aircraft.
• Strong proficiency in control theory, dynamic modelling, and simulation tools.
• Familiar with DO 160, DO178 and DO254.
• Excellent problem-solving and analytical skills.
• Effective communication and teamwork abilities.
• Fluent English skill is a must.

We regret that only shortlisted candidates will be notified.

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.

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.

We are seeking a dedicated and organised Credit Control executive to support the Finance Manager. You will play a crucial role in supporting the credit management function, including liaision with customers and internal staff. If you are proactive with a positive attitude, we are inviting you to join our organisation.

Duties:

• Responsible for credit control activities, which would include the following:
• Manage and maintain debtor's accounts to ensure the accounts are current.
• Monitor Accounts Receivables closely and ensure timely update of receipts from clients into accounting system.
• Close liaison with customers to ensure the timely collection of payment.
• Support any duties with our billing team to ensure in compliance to accounting standards, government regulations, internal policies and credit control policies.
• Any other ad-hoc duties assigned.

Requirements:

• Past experience as a Credit Controller is favourable, preferably in a fast-paced business environment
• Exceptional organisational skills and attention to detail, with the ability to multitask effectively
• Ability to multi-task
• Strong problem-solving abilities and the capacity to work independently with minimal supervision
• Basic knowledge of accounting system experience
• Proficiency in using Microsoft Office Suite (Word & Excel)
• Professional demeanour and the ability to interact confidently
• Discretion and the ability to handle confidential and sensitive information with integrity
• Flexibility and adaptability to accommodate changing priorities and tasks

Location:

• We are located in the West, 3 minutes walk from Gul Circle MRT

You may also email us your resume to [email protected].

Company Description

Cogent Holdings Pte Ltd is a wholly-owned subsidiary of Cosco Shipping International (Singapore) Co., Ltd, located in Singapore. The company manages over 4 million square foot of industrial spaces, 400,000 square foot of commercial spaces, and has a wide range of clientele ranging from local SMEs to multinational companies. Cogent's main businesses comprise warehousing, freight forwarding, container and ISO tank depot, automotive logistics, and transportation services in Singapore. It also operates warehousing and container depot businesses in Malaysia.

Role Description

This is a full-time on-site role for an Executive in Internal Control and Compliance. The Executive will be responsible for the following duties:

1. Assist in executing and maintaining the guidelines in internal control.

2. Assist in reviewing and assessing the soundness, effectiveness, and proper application of internal controls, compliance procedures, and controls and timeliness of document generation.

3. Assist in organizing and carrying out the internal controls function; maintain and update the audit manual, audit scope, and audit plan.

4. Work with the team to conduct internal audits, present audit reports, and document the internal audit process.

5. Assist with the follow-up of any ad-hoc audits, when required.

6. Support the team to evaluate compliance with existing standards, guidelines, methodologies, policies, and procedures; identify and propose changes to existing standards, guidelines, methodologies, policies, and procedures to reduce risks and enhance control.

7. Highlight risk management issues and internal control deficiencies identified and work with the team to provide recommendations to improve the entity’s operations.

8. Work with team members from departments and business units to handle risk-related ad-hoc projects, when necessary.

9. Assist in reviewing the responses to internal and external audit results to ensure that recommendations are implemented and all action items are resolved.

10. Assist in evaluating regulatory compliance programs.

11. Any other duties and responsibilities assigned from time to time.

Requirement:

1. Degree in Accountancy

2. 3 – 5 years of internal audit experience

3. Certified Internal Auditor preferred.

4. Good interpersonal skills and communication skills

5. Highly motivated and strong analytical skills

6. Experience in handling a project

7. Experience in operational risk, quality assurance or other audit-related experiences.

8. Experience in evaluating internal policies and procedures, operational processes and documentation.

9. Advanced skills in MS Office and databases

10. Able to travel overseas for job assignments

Others Information:

1. 5-day work week

2. Meal allowance

3. Medical, dental & insurance benefits

4. Company Transport: 2 ways from Jurong East

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

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 Descriptions:

* Development & Implementation of Instrumentation & Control, Robotic, Building Automation, Industrial Automation, Process Control Application.

* Implementation of Process Automation, Instrumentation and Control, Testing and Commissioning, Technical Support, Customer Service, PLC Programming, SCADA / HMI programming, Computer and Server, Industrial Networking

* Responsible for design & development, implementation, onsite testing & commissioning, support, documentation and training

* Ad-hoc engineering support to customer when required.

* Willing to work on fast pace environment.

Job Requirements:

* Relevant graduate degree for Engineering (Electrical, Mechanical, Computing, or Mechatronic)

* Min 1-2 yrs experience in good engineering practice, process automation, robotic, service and maintenance. Fresh graduates are welcome.

* Hands on experience in instrumentation implementation

* Knowledge of Building Automation & Process Control

* Experience in BMS / PLC / HMI process control / automation system, onsite commissioning

* Good technical skills in Allen-Bradley / Siemens PLC programming, SCADA

* Strong problem-solving and analytical skills

* Hardware configuration and software coding

* IT knowledge for Server/Client and Infrastructure

* Electrical, instrumentations and control knowledge

* Customer orientated

* Analytical thinking

* Good communication skills for both written and spoken

* Ability to work well with others in a team environment, providing input and feedback in a helpful manner.

* Able to interact well with vendors.

* Strong team player with excellent interpersonal and communication skills, ability to work independently, Pro-active and able to work in a fast paced environment and handle multiple tasks when required.

Interested applicant please send resume with expected remuneration to [email protected]

We regret that only shortlisted candidates will be notified.

Basic Functions:

1. Assist in maintaining company’s compliance to quality management system established.
2. Responsible in monitoring the calibration and maintenance program.
3. Responsible in internal and external audit program.
4. Ensure that ISO 13485, In-vitro Diagnostics Directive 98/79/EC, IVDR 2017/746 and 21 CFR Part 820 Quality System Requirement, MDSAP (Medical device Single Audit Program), ISO 9001 are properly implemented and maintained at all levels.
5. Establish and maintain proper document archiving and control system.

Duties:

1. Assist in maintaining company’s compliance to quality management system established.
2. Responsible in internal and external audit program.
3. Assist in handling the corrective and preventive action system and its sub-system (i.e. Nonconforming product and internal audit).
4. Ensure that proper document control procedure and system is implemented for Product Specifications, Operation Manuals, Standards, Drawings and all quality related documents.
5. Co-ordinate, review, collate, update and issue all quality-related documents to relevant personnel.
6. Responsible in calibration and maintenance program
7. Responsible in the equipment validation and process validation.
8. Ensure that all documents submitted and/or generated are archived.
9. Perform other duties as assigned.

Requirements:

Ability to:

1. Demonstrate the use of all equipment, materials, and techniques relevant to job performance, execute and maintain pertinent validation protocols as required and maintain quality standards.
2. Establish quality assurance system and undertake systems / product / process validations.

Knowledge of:

Various quality control/process control requirements, quality management system and documentation relating to biomedical and /or IVD products. Technical terminology used in the laboratory, assigned scientific techniques and knowledge of QC procedures governing a number or basic laboratory operations

Education: Basic Science Degree

Experience: 5yrs of relevant experiences. Experiences in ISO 9001 or ISO 13845 is a plus. Certification with lead auditor or internal auditor is a plus.