![Ani Asia-Pacific Holdings Pte Ltd](https://media.trabajo.org/img/noimg.jpg)
Regional Quality Assurance Intern
1 month ago
POSITION SUMMARY:
The Regional Quality Assurance Intern will provide valuable support to the Regional Quality Assurance (RQA) Team in maintaining and enhancing Quality Management Systems of the regional office to help the APAC commercial business activities.
KEY RESPONSIBILITIES:
1. Quality Management System
- Assist in tracking and updating internal and external audit findings, CAPA, and Change Controls
- Handle Records & Data Control and Maintenance – Organizing records and documents
- Contribute to developing regulatory compliance procedures, guidelines, and templates as needed
- Review and adjust procedures to align with standards, regulations, and practices changes
- Participate in internal and external audits to ensure compliance requirements are fulfilled
- Review and close non-conformances (NC) and CAPA cases
2. Aid RQA in Product Quality Complaints Management
- Support the QMS in managing quality complaints
- Collaborate with local quality stakeholders and manufacturers on product complaints
- Assist in investigating product complaints and ensuring their resolution
- Maintain the product complaint database and conduct Product Complaint Trend Analysis
- Conduct periodic reconciliation with Pharmacovigilance (PV)
3. Assist RQA with Incoming Release activities:
- Conduct incoming release checks to ensure products comply
- Assist in product quality investigations as necessary
- Coordinate with supply chain and quality assurance to resolve compliance issues
- Maintain quality records
4. Support RQA Training Coordinator in:
- Updating training plans for departments based on job requirements
- Collaborating on training plan maintenance and material documentation
- Acting as a point of contact for employees regarding training needs
- Keeping training records up to date
5. Contribute to other assigned projects.
- Implement Electronic QMS (TrackWise) across APAC Regional and Local QA departments
- Execute Documentum across APAC Regional and Local QA
- Engage in MILab – Product study and Process development
KEY REQUIREMENTS:
1. Experience and qualification
- Hold a Diploma or degree in science or a related discipline
- Proficient in MS Office and Google Workspace applications
2. Competencies and soft skills
- Growth Mindset
- Passionate about making enhancements and driving change
- Proactive, independent, and capable of working under pressure
- Task-oriented, motivated, and able to work within deadlines
- Skilled at engaging stakeholders and navigating ambiguous environments
- Effective communication skills, both verbal and written
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