Job Description

About Kyowa Kirin

Kyowa Kirin strives to create and deliver novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company with a more than 70-year heritage, the company applies cutting-edge science including an expertise in antibody research and engineering, to address the needs of patients and society across multiple therapeutic areas including Nephrology, Oncology, Immunology/Allergy and Neurology. Across our four regions \xe2\x80\x93 Japan, Asia Pacific, North America and EMEA/International \xe2\x80\x93 we focus on our purpose, to make people smile, and are united by our shared values of commitment to life, teamwork/Wa, innovation, and integrity. You can learn more about the business of Kyowa Kirin at: https://www.kyowakirin.com



Kindly note that only undergraduates based in Singapore can be candidates for this position.

JOB PURPOSE

This position is to assist APAC QA department on management and maintenance of regional and local quality management system procedures and its associated system or processes.

KEY RESPONSIBILITIES

• Assist APAC Quality System (QS) Manager to manage and follow up on activities that implement to improve the organization\xe2\x80\x99s Quality Culture
• Assist QS Manager to create, maintain and monitor quality KPI dashboard and implement initiatives to improve quality Metrics across APAC region.
• Work closely with QA department and other Business Operations department to develop (include design and establish) and review standard operating procedures and work instructions.
• Assist in generation of training material and plan training schedule.
• Assist in developing checklist for Global Consistency Check Project
• Assist the QA Manager in coordinating, establishing and documenting risk management programs (such as FMEA) on the quality management system processes and establish risk/aspects/hazards/harms control measures through documentations and records, maintain the effectiveness of the quality management system through reviews and trainings.

POSITION REQUIREMENTS

Education:Pursuing a Diploma or Degree in Pharmaceutical Science, Quality Engineering, Biomedical Engineering, Chemical Engineering, Supply Chain and/or equivalent from University in Singapore

Experience:

• No industrial experience required.
• Must have ability to design systems through mind-mapping and creating chain-of-thoughts with great understanding of possible solutions and consequences.
• Experience in IT/Computer \xe2\x80\x93 system / database admin or equivalent.

Knowledge, Skills & Abilities:

• Strong interest in Quality Management System, Quality Assurance and Quality Control scope of work.
• Determination to learn new skills/abilities, keen on acquiring new knowledge and self-improvements.
• General knowledge on GxP (GDP, GMP, GPV, GDocP etc.) is preferred.
• Proficient in MS Office applications (Excel, Words and Power-point) and strong IT skills (to utilize SharePoint sites, team sites, local repositories and etc).
• Ability to work within cross-functional team environments.

SUPERVISION PLAN

• Intern will be assigned to more than 1 Mentor within the department (QS/QA Manager)
• Basic Functional Training, induction program and access to eQMS will be provided within 1 month of joining
• Set up OJT and expectation at the start of the program
• Assignment will be issued based on the department need may cover some or all of the key responsibilities area
• Expected to develop project management skill when assignment is issued.
• Weekly review of project progress with mentor

Application Instructions

Please apply for this position by submitting your text CV using InternSG.
Kindly note that only shortlisted candidates will be notified.

InternSG