Quality Assurance & Regulatory Affairs Executive

Quality Assurance & Regulatory Affairs Executive (Mandarin Speaker) #MSL

Description

Job Scope

•Implement quality assurance policies and procedures to ensure compliance with applicable regulations and standards.

•Support all aspects of the Quality Management System including updating QMS manuals, SOPs and forms, conducting internal audits, and follow-ups on NC/CAPA.

•Investigate and resolve quality issues, including customer complaints and non-conformances, in a timely and effective manner.

•Responsible for new product registration – assess requirements, compile dossier, including liaising with distributors and other related processes.

•Complete the relevant steps for product changes/renewals including communications with distributors and local authorities, and reviewing regulations and guidelines.

•Review advertisements such as digital ads, in-store collaterals, social media contents and related processes.

•Stay abreast of regulatory developments and industry trends to ensure timely compliance with evolving requirements.

•Support the development and implementation of training programs to enhance awareness and understanding of quality and regulatory requirements across the organisation.

•Support in any other QA and RA matters on an ad-hoc basis.

Requirements

•At least a Bachelor’s degree in science from an accredited university, preferably relevant to Pharma/Medical related topics.

•Excellent verbal and written communication skills with strong English proficiency.

•Good proficiency in Mandarin  will be preferred (to review ads) and ability to comprehend in the Japanese language will be a plus point.

•Minimum 2 years of experience in quality assurance and regulatory affairs.

•Strong understanding of regulatory requirements, especially in the Cosmetic and Pharmaceutical industry will be an advantage.

•Experience with quality management systems, such as ISO 9001 and GDP.

•Ability to work independently and communicate effectively with cross-functional teams and external stakeholders.

•Detail-oriented with a commitment to excellence and continuous improvement.

Industry

FMCG, Retail & Luxury

Specialization

IT - BA/ QA / PM
Others

Location

Kuala Lumpur

Employment Type

Contract / Temp

Salary

MYR 4, 501- MYR 6, 000 / mth

To apply online please click the 'Apply' button below. For email a detailed resume in Word format to Stella Lee.

For further discussion about this role, please find contact details of Stella Lee as below:
Email:
Tel:
*All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.