[ref. a62518702] QA / RA Specialist - Toa Payoh
Private Advertiser Toa Payoh Full-time
- Coordinates the process of product registration and market access approval in the designated countries including providing all required documents and certificates within the specified timeframe proactively to complete product registration.
- Provides advice to internal and external teams in interpreting relevant guidance documents and standards.
- Contact local authorities and organizations for both regulatory problems solving and obtain updated information on current and developing regulations.
- Review and approve documents to support Post Market Change notification (including labelling changes) to comply with international regulations and standards.
- Remain up to date on regulations and communicate any key changes to stakeholders in the broader organization.
- Provide training when necessary and assist with the development of the respective countries’ Regulatory Affairs infrastructure to facilitate greater speed to market.
- Take charge of QA (complaint reporting etc) for all subsidiaries.
- Analyze and make recommendations regarding complaints received and whether they are reportable within the designated areas; participate in post-market surveillance activities as necessary.
- Submit complaint reports to factory, and follow up with investigation with factory, subsidiaries and/or customer.
- Report Field Safety Correction Action (FSCA) and adverse events to Authorities when necessary.
- Coordinate recall activities.
- Maintain database of all complaints and generating summary reports when necessary.
- Responsible for Good Distribution Practice for Medical Devices (GDPMDS) for Singapore office.
- Conduct and participate in support internal and external audits when required.
- Maintain and submission of National Environmental Agency (NEA) Mandatory Packaging Reporting (MPR).
- Responsibility for all regulatory-related issues to machines.
- Coordinate with Japan counterparts Team and the QA/RA team.
- Follow up Customer Experience Report.
- Follow up daily activity of Technical Management system (Service software) with regional countries daily.
- Maintain Machine installation data based. (using sales data)
- Coordinate with respective countries to get updated installation information monthly.
- Any other ad-hoc duties which the superior may assign from time to time.
MANPOWER STAFFING SERVICES (SINGAPORE) PTE LTDToa Payoh
and calibration of instrument / equipment.
• Assist QA Engineer in quality evaluation.
• Provide quality information & data to support QA Engineer in decision making.
• Report to QA Engineer all gags, fixtures and measuring equipment which are out of calibration...
Leong Guan Food Trading Pte LtdWoodlands, 13 km from Toa Payoh
safety systems (ISO, HACCP, SFA) are rock-solid and audit-ready
• Lead and coach junior QA staff across both fresh noodle and tofu product lines
• Conduct internal audits at our production lines and our logistics
• Run food safety training...
Super Bean International Pte LtdToa Payoh
Job Description
• To conduct regular visits to stores for audit purposes
• Prepare Halal / QA audit and investigation reports
• Assist in performing product or Food Quality check & adherence as expected and directed by the Company
• Ensure...