Quality Assurance and Regulatory Affairs Executive
6 months ago
Adopt policies and processes for quality assurance to guarantee adherence to relevant laws and guidelines.
- 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 promptly address quality-related concerns, such as non-conformances and customer complaints.
- In charge of registering new products: evaluate specifications, put together a dossier, communicate with distributors, and handle other relevant procedures.
- Complete the relevant steps for product changes/renewals including communications with distributors and local authorities, and reviewing regulations and guidelines.
- Examine marketing materials, including digital ads, in-store collateral, social media posts, and associated procedures.
- Stay abreast of regulatory developments and industry trends to ensure timely compliance with evolving requirements.
- Encourage the creation and execution of training initiatives aimed at raising organizational awareness and comprehension of quality and regulatory standards.
- Support in any other QA and RA matters on an ad-hoc basis.
**Requirements**:
- Acquire a science degree from an accredited university, especially with a focus on pharmacology or medicine.
- 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.
- It will be advantageous to have a solid awareness of regulatory regulations, particularly as they relate to the cosmetic and pharmaceutical industries.
- Experience with quality management systems, such as ISO 9001 and GDP.
- The capacity to collaborate with external stakeholders and cross-functional teams while operating autonomously and communicating well.
- Detail-oriented with a commitment to excellence and continuous improvement.
**Job Types**: Full-time, Contract
Contract length: 24 months
Pay: RM3,500.00 - RM5,000.00 per month
Schedule:
- Monday to Friday
**Education**:
- Bachelor's (preferred)
**Experience**:
- Quality assurance: 2 years (preferred)
- Regulatory Affairs: 2 years (preferred)
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