Quality Assurance & Regulatory Affairs Description Principal Function As a Quality Assurance (QA) and Regulatory Affairs (RA) Executive, you will play a key role in ensuring compliance with relevant regulatory requirements and maintaining the highest standards of quality across our organization. You will collaborate closely with cross-functional teams to implement and maintain quality management systems and regulatory processes.
Key Responsibilities 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 Possess 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 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 Amanda Loo.For further discussion about this role, please find contact details of Amanda Loo as below:
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