Quality Assurance

3 months ago

Kuala Lumpur, Malaysia Recruit Express Service Sdn Bhd Full time

**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.

This role will report to the QA & RA Manager based in Singapore.

**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.

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

Pay: RM3,500.00 - RM5,000.00 per month

**Benefits**:

- Opportunities for promotion
- Professional development

Schedule:

- Monday to Friday

Application Question(s):

- What is your expected salary?

**Experience**:

- QA & RA: 3 years (preferred)

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