Total 6 quality assurance job vacancies in Singapore Changi

Duties and Responsibilities:

a) Monitor compliance to airworthiness regulatory requirements and quality standards

b) Conduct of internal quality audits and vendor audits

c) Facilitate training on regulations and quality related subjects

d) Support Safety Management System program

e) Perform capability evaluation reviews

f) Administrate personnel authorisation approval

g) Conduct quality investigation, analysis and drive corrective actions

h) Maintain Quality related KPIs

i) Comply with Health, Safety and Environment (HSE) regulations as prescribed by local law and company’s policies.

j) Participate and contribute to HSE initiatives & Corporate HSE programs and in HSE risk communications & mitigations.

k) Support to in Continuous Improvement Program

l) Any other duties as assigned

Experience and Qualifications:

a) Diploma / Degree holder in mechanical / electrical / electronic engineering or equivalent

b) Relevant CAAS papers qualification or equivalent will be advantageous

c) Minimum 2 years relevant working experience in aviation field is preferred

d) Knowledge on airworthiness regulatory requirements and AS9110 Standards

e) Trained Internal Quality Auditor / Lead Auditor is preferred

f) Safety Management System trained will be an added advantage

g) Good communication and writing skills

h) Knowledge in MS Office (Excel, Word, Powerpoint, Power BI), SAP, etc

i) Willing to work excess hours when required

j) Able to do business travel in short notice

k) Possess knowledge of statistical tools and methodology

l) Good team player and ability to handle tight datelines

1. Training Program Strategy and Development

• Develop and implement a comprehensive global training strategy aligned with business objectives.
• Design and oversee the development of training programs for various departments, including GMP, quality, regulatory etc.
• Ensure training materials are up-to-date, engaging, and compliant with regulatory requirements.
• Implement innovative training methodologies, including e-learning, virtual reality, and blended learning approaches.
• Select and manage external training vendors and consultants.
• Ensure external training solutions meet company standards and regulatory requirements.

2. Regulatory Compliance

• Ensure all training programs meet GxP requirements and other relevant regulations
• Stay informed about industry trends and regulatory changes affecting pharmaceutical training
• Participate in regulatory inspections and audits related to training

3. Quality Management

• Integrate training initiatives with the company's quality management system
• Develop and maintain SOPs related to training processes
• Implement quality metrics to measure the effectiveness of training programs

4. Learning Management System (LMS) Oversight

• Oversee the implementation and management of the company's LMS
• Ensure proper documentation and tracking of all training activities
• Utilize LMS data to generate reports and analytics for continuous improvement

5. Cross-functional Collaboration

• Collaborate with leadership team to identify and address organizational training needs
• Work closely with Quality Assurance, Regulatory Affairs, Human Resources, and other departments to align training initiatives
• Collaborate with subject matter experts to develop technically accurate training content

6. Budget and Resource Management

• Manage the training department budget
• Lead and mentor a team of training management quality professionals across multiple sites
• Allocate resources effectively across global training initiatives

7. Continuous Improvement

• Regularly assess the effectiveness of training programs and implement improvements
• Stay updated on adult learning theories and innovative training technologies
• Establish forums for knowledge sharing and best practice exchange across global sites

Supplier Scouting (20%)
- Support potential supplier scanning.
- Support project documentation and presentation.
- Liaise with various departments/divisions on information gathering.
- Research of free trade agreements within ASEAN.

System Data & Contracts Maintenance (30%)
- Support in ensuring data quality on various purchasing tools.
- Prepare contract documents with suppliers and route for signatures.

Purchasing Support (20%)
- Provide support to other business functions with regards to enquiries about pricing, master data 
maintenance.
- Ensure documents / approvals are in place for Mitigation checks.
- Preparation and sending of mass communications to suppliers.

Purchasing Quality (30%)
- Support team members in the ISIR by checking documents for accuracy and requesting technical 
information (test reports, drawings) from suppliers.
- Create and implement Engineering Change Notifications for the ASEAN region to approve changes of 
products, manufacturing processes, materials or packaging.
- Support in releasing new products and maintaining related internal processes and systems.
- Assist investigations of customer complaints.
- Update system for certificates, audit reports, etc.
- Assist problem solving with suppliers.

Authorities and Responsibilities

1. Responsible for providing directives for the Quality Assurance Department in meeting management objectives.
2. Formulate, implement and evaluate quality strategies programs for the company.
3. Implement and maintain a system of auditing the facility and periodic calibration of test, measuring equipment and tools.
4. Manage customer complaints, corrective and preventive action programs.
5. Administer and manage continuous improvement program for all QA processes.
6. Work closely with auditors, customers, production and suppliers to meet the quality requirements.
7. Manage sub-contractors for on-time supply of treatment process, as well as meeting technical requirement.
8. Review / prepare, administer and implement Quality Assurance Plans, Inspection Test Plans and other Operational procedures in accordance to the technical specifications, customer's surveillance requirements, and good manufacturing / engineering practices, and enforce the same on Operations in their execution.
9. Work closely among inter-department to ensure committed schedules are met in a timely and effectively manner.
10. Review and approve disposition program / action for nonconforming products.
11. Ensure that processes needed for the quality management system are established and implemented.
12. Report to top management on the performance of the quality management system, and note needed improvements.
13. Ensure the promotion of awareness of statutory, regulatory and customer requirements throughout the organization.
14. Ensure and coordinate the implementation of risk assessment and risk control of medical devices

The Quality Assurance Manager plays a crucial role in business by ensuring that products meet certain standards of quality. He/She plans, directs or coordinates quality assurance programs and formulate quality control policies. He/She also works to improve an organisation's efficiency and profitability by reducing waste. He/She prepares and update quality documentation, basing their processes on a recognised standard such as ISO 9000 – Quality Management, published by the International Organisation for Standardisation. He/She supervises teams of inspectors who carry out the detailed assessment of products and their components at different stages of production. He/She recruits and trains supervisors, and provides them with documented quality standards as guidelines for their daily work. He/She also selects quality inspection tools and software to support the inspection team.

Competence Requirements:

• Diploma in Mechanical Engineering / Quality Engineering or equivalent.
• Minimum 6 years of solid experience in Quality Management in similar or related industry and 3 years in management level.
• Good knowledge in implementing and up keeping Quality Management System.
• Strong leadership and good interpersonal skills.
• A team player with strong sense of responsibility to ensure plant effective quality performance.

~ Assist in the implementation of company quality systems.
~ Conduct Quality Assurance audit.
~ Manage cause investigation for non-conformance.
~ Manage company quality systems.
~ Manage departmental activities and deployment.
~ Able to commute between Tuas Plant and Loyang Plant.

JOBSCOPE OVERVIEW

1. Represent QA/QC department in 2G Management Meetings or other meetings required by Directors.

2. Create and maintain standard operating procedure (SOP’s), protocols, guidelines that ensure consistency and efficiency throughout the QA cycle.

3. Acts as Committee of all ISO audits.

4. Supervise and manage QA/QC team and interns.

5. Conduct physico-chemical and microbiological test for Chemicals and Incoming Paper.

6. Liaise with suppliers and third-party agencies.

7. Provide technical support to the sales and marketing team regarding product specifications, sample requirement & others.

8. Document those methods in standard operating procedures (SOPs) and production records, quality assurance activities with internal reporting and audits.

9. Review and compile documents for Audits (Batch Record: Prod sheet, Quality control test Reports; FG and RM Reports, Mixing records).

10. Ensure that on time calibration program of equipment (mechanical and lab instruments, weighing scales and test weights) are executed.

11. Assist to do in compounding and mixing when Mixer Operator is on leave.

12. Liaise with Overseas factory (China and Indonesia) to ensure that product or service meets specified requirements.

13. Review method validation study reports, ensure proper documentation of findings, and assist in approval or re-validation recommendations. Prepare summary reports of validation activities, results, and recommendations for management review.

14. Investigate validation failures or deviations, identify CAPA, and ensure implementation. Collaborate with cross-functional teams to enhance the efficiency and effectiveness of validation activities.

15. Identify risks in testing methods, implement mitigation strategies, and ensure data integrity during validation to maintain accuracy, reproducibility, and regulatory compliance.

16. Review and approve method validation documentation, ensuring accuracy, completeness, and compliance with quality standards. Maintain up-to-date records of validation activities, deviations, CAPA, and ensure proper version control for all related documents.

17. Provide training on method validation processes and best practices, and support Production, QC and R&D teams in executing protocols and analyzing data accurately.

18. Any other area of responsibilities that the company deems necessary.

A. QUALITY CONTROL

1. Manage product complaints or non-conformances; thoroughly investigate process failure, determine the root cause, and take prompt corrective actions.

2. Conduct physical, physico-chemical test and microbial analysis of finished product.

3. Track the materials (chemicals and fragrance) that are present in the chemical room and know whether additional supplies need to be ordered.

4. Calibrate all equipment for In-house verification Example – pH meter, weighing scale etc. and arrange external calibration with external party.

5. Train new production operators in quality control.

6. Any other area of responsibilities that the company deems necessary.

B. LIAISE WITH SUPPLIERS (Services):

1. DI Water System Maintenance (Requirements: According to Contract): Loop Sterilization, UV-Lamp etc.

2. Complete Water Quality Testing (annual) by External Lab

3. Monitor the consumable supplies from different suppliers for DI Water (Column, filters, gauges).

4. Wet Wipes Monthly External Microbial testing

5. Monitor the annual cleanroom Certification.

6. External Calibration of Equipment

7. Any other area of responsibilities that the company deems necessary.

C. PRODUCT TECHNICAL SUPPORT

1. Support Export Sales and Marketing for preparation of documentation for regulatory use (COA, Ingredient’s list, FG and RM spec etc).

2. Collaborate with development, QC, and regulatory teams to plan, execute, and review method validation protocols, ensuring compliance with applicable guidelines (e.g., ICH, FDA, EMA) and company procedures, while meeting regulatory standards for intended use.

3. Support on the process validation on the manufacturing of the product.

4. Any other area of responsibilities that the company deems necessary.

Job Description

To perform inspection by using CMM & other measuring equipments

To ensure parts are according to customer's requirements

Job Requirements

Higher NITEC level in technical engineering or GCE 'O' level

Minimum 1 year related working experiences

Able to operate CMM machine independently is an advantage

Able to commit overtime

Good team player

Independent