Total 2 Fresh/Entry Level Product Safety Manager inKuala Lumpur job vacancies in Quality Assurance / Control category in The United States of America

The Role:

• Assist in arranging sampling & testing for various materials such as starting materials, packaging materials & finished products etc;
• Assist in managing work allocation of frontline QC staff to ensure all QC resources are fully utilized in an effective way;
• Devise and review GMP documents such as various material specifications, SOPs, training materials;
• Review and manage various Batch Production Records, various record forms & test reports;
• Involve in various validation activities, equipment calibration activities and product stability studies;
•  Assist in EM / compressed air and purified water monitoring program
•  Provide and maintain training program for all QC staff with preset schedule;
• Assist in Quality Management System Implementation such OOS investigation, Risk Assessment, Deviation & Incident Investigation Management, Product Quality Complaint & CAPA etc.

• Degree holder in Chemistry, Chinese Medicines, Microbiology, Biochemistry, Pharmaceutical Studies or related disciplines.
• Having at least 3 years’ experience in pharmaceutical industry
• Experience in chemical analysis of TCM and/or pharmaceuticals, and preferably with microbiological analysis experience.
• Familiar with PIC/s GMP is an advantage.
• More experienced, you will be considered as QC Supervisor.

• Casual Dress Code: Freedom to dress comfortably at work.
• Health & Wellness: Comprehensive health insurance (available on the first day of work).
• Free Shuttle Bus: with less than 1 hour journey from all around Hong Kong 
• Annual Health Check-ups: Regular health screening at no cost.
• Generous Leave Policies: Paid annual Leave, birthday leave, study leave, Vacation leave.
• Company Discount: Reduced prices on company products and partnered restaurants and stores.
• Growth: Rapid growth opportunities for strong performers.
• Great Opportunities: Chance to work on cutting-edge marketing projects.

Responsibility :

This Safety Assurance Engineer is reporting directly to the Safety Assurance Manager.

This Engineer is responsible of implementing and improving all required processes in Telecommunication, Signalling and Revenue Collection Service (AFC) domains to ensure compliance to EN50126/EN50128/EN50129/EN50159 for solutions, bids and projects.

Mission :

• Ensure RAMS strategy is flowed down throughout the organisation
• Implement the GTS Safety Maturity Model and RAMS Processes
• Define and perform RAMS activities under supervision of Safety Assurance Manager
• Interface the customer for project RAMS management
• Interface the organisation management for RAMS activities internal reporting
• Lead or participate to Hazard Identification and Analysis Workshops with Customer/Interfacing Parties
• Prepare or support preparation of Safety Case
• Coordinate with Independent Safety Assessor (ISA)
• Maintain KPI on RAMS activities including : Quality, Cost and Deadlines
• Puts in place Assurance Gates for : Installation, Testing and Commissioning
• Ensure all Testing & Commissioning evidence are validated from Safety Point of view
• Work with other members of the Safety Assurance team
• Other tasks as assigned by the Safety Assurance Manager

Pre-requisite :

QUALIFICATIONS

• Tertiary qualification in Engineering Fields of Mechanical, Electrical, Electronic, Computer Science, Information Technology or related discipline (essential)
• Higher degree qualifications are desirable
• Good knowledge on CENELEC (EN) Railway RAMS Standards (desirable)

ESSENTIAL EXPERIENCE

• 2-3 years experience in an RAMS role.
• New Graduates are also considered and welcome to apply

DESIRABLE EXPERIENCE

• Knowledge of Thales Products and Processes
• Experience working within a full Systems Engineering lifecycle
• Experience in Transport (MRT, LRT) Projects