[ref. d40009017] QA / RA Specialist - Geylang
Private Advertiser Geylang 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 LTDGeylang
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...
Super Bean International Pte LtdGeylang
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...
Leong Guan Food Trading Pte LtdWoodlands, 17 km from Geylang
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...