Quality Assurance and Regulatory Affairs Executive

3 months ago


Kuala Lumpur, Malaysia Recruit Express Service Sdn Bhd Full time

**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.

**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.

**Job Type**: Contract
Contract length: 24 months

Pay: RM3,500.00 - RM5,000.00 per month

Schedule:

- Fixed shift
- Monday to Friday

**Experience**:

- Quality assurance: 2 years (preferred)

**Language**:

- Mandarin (preferred)


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