DCH Auriga (Malaysia) Sdn Bhd is looking for new potential candidates to fill in for Supervisor - Quality Assurance position. If you currently looking for new healthcare job opportunities and qualified with the job desc, feel free to apply this job.
As a Management Representative (MR) having the following authority and responsibility according to the requirements of ISO & GDMPD including:
a) Ensuring that processes of the quality management system are established and maintained.
b) Reporting to top management on the performance of the quality management system, and any need for improvement.
c) Ensuring the promotion of awareness of customer requirements throughout the organization.
d) To liaise with external parties on matters relating to the quality system.
1. Maintenance of Quality and Regulatory requirements in accordance to the service scope contracted with existing and future Clients. All in accordance to the requirements of the industry by regulatory agencies and the Ministry of Health.
2. Develops reviews and maintains quality procedures and records to ensure compliance with quality regulations and best practices
3. Develops and/or updates company complaints management and inspection procedures to ensure issues are captured and investigations occurs, as well as proper categorization of complaints by product- or distribution- related, severity of the consequences of the complaints and proper documentation of complaints.
4. Lead/ conduct internal audit & participates in internal &external quality audits.
5. Collaborates with cross functional personnel to provide root cause investigation and develop corrective actions to respond to:
- Complaints logged
- internal and external audit findings
6. Responsible for the organizational structure, roles and day-to-day operations of the Quality Control team for Medical Devices / Pharmaceuticals
7. Builds expertise and ownership to establish and continually improve validation quality system and to ensure accuracy, completeness and compliance.
8. Supports the execution of process or equipment validations, revalidations, re-qualifications, and on-site projects.
9. Ensure there is prompt and effective communication both internally and externally to keep all interested parties informed proactively. This includes but not limited to superiors, subordinates, colleagues, principals and customers.
10. Reviews and executes validation protocols and summary reports and ensures those are technically correct and comply with internal and external requirements
11. Ensures products meet all quality standards and are in compliance with the necessary quality requirements / regulations prior to product release
12. Participates in quality improvement projects
13. Foster close working relationships with the Management Team and all Business Department/Section Heads in communication, development and follow-up of quality assurance implementation of validation to support the company’s Quality Management System for Central Warehouse
14. Ad Hoc duties as instructed by immediate superior.
15. Develops a high performing Quality Assurance culture within the team and Company.
16. Identifies training needs and coaching opportunities to develop highly skilled team.
- Candidate must possess at least a Diploma, Advanced/Higher/Graduate Diploma, Bachelor's Degree, Post Graduate Diploma, Professional Degree, Logistic/Transportation, Others, Quantity Survey or equivalent.
- Required language(s): Bahasa Malaysia, Mandarin, English, Tamil
- At least 2 year(s) of working experience in the related field is required for this position.
- Preferably Junior Executives specializing in Healthcare - Pharmacy or equivalent.
- Full-Time position(s) available.
How To Apply
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