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Quality assurance

4 months ago


Kuala Lumpur, Kuala Lumpur, Malaysia Recruit Express Sdn Bhd Full time
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 & LuxurySpecialization IT - BA/ QA / PMOthersLocation Kuala LumpurEmployment Type Contract / TempSalary MYR 4, 501- MYR 6, 000 / mthTo 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.