Quality Assurance Manager

6 days ago

Singapore FEI FAH MEDICAL MANUFACTURING PTE LTD Full time

Implement QA & QC procedures in accordance with Audit outcomes
- Perform internal audits and **BMPR **checks in accordance with **cGMP **standards on production batches to ensure quality
- Main Coordinator for renewal of **GMP **with **HSA **& other authorities, reporting to management
- Conduct training for all personnel in matters of quality processes and auditing
- Maintain quality manual and SOPs for quality procedures, and create new procedures and SOPs where required
- Maintain quality records including **BMPR, SPC chats **, **stability records **, laboratory tests, and validation records
- Maintain calibration records and standards for the equipment in the company
- Handle product registrations from health regulators ( **HSA, FDA, HK HD, TGA **) to successful completion
- Assist in the development of new products with quality and product expertise
- Assist in product registration and listing with local authorities and customers
- Promote, develop, and implement quality management strategies and plans throughout the organization
- Manage all quality audits and inspections conducted by health authorities both local and foreign
- Inspect all goods according to the drawing specification and related instruction
- Any other ad-hoc duties assigned by superior

**Job Requirements**
- Required language(s): English, Chinese (in order to conduct training for all English and Chinese-speaking personnel in matters of quality processes and auditing and also, to assist in product registration and listing with local authorities and Chinese-speaking customers.)
- At least 3 Years (s) of working experience in the related field is required for this position.
- Specialized in Quality Control / Assurance or equivalent
- Able to start work immediately or within short notice

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