Location: Ubi
Salary: Up to $3,900/month
Working Hours: Monday to Friday, Office Hours
Key Responsibilities:
- Ensure compliance with federal, state, local regulations, and internal policies.
- Perform compliance assessments (e.g. process/facility inspections, equipment reviews, record audits).
- Review SOPs, batch records, deviations, change controls, and CAPAs.
- Support sponsor site visits, regulatory inspections, and client audits.
- Recommend and help implement corrective and preventive actions (CAPA).
- Conduct regulatory training sessions and maintain training records.
- Perform internal facility inspections and maintain audit documentation.
- Approve customer test reports and support reagent release processes.
- Monitor and help correct regulatory risk areas.
- Assist in audits of vendors, subcontractors, and suppliers.
- Collect and analyze Quality Metrics for QMR and QMS dashboards.
- Support Quality Assurance projects and continuous improvement efforts.
- Provide regulatory responses and documentation for customer qualification.
Qualifications:
- Min. Bachelor's Degree in Life Sciences or equivalent.
- Min. 2 years in a Quality Assurance role.
- Proficient in Microsoft Office applications.
- Excellent written and verbal communication.
- Strong attention to detail and organizational skills.
- Ability to follow instructions and work independently.
If interested, please email me at [Confidential Information] or telegram @kellynlytan
Kellyn Fullviana
(CEI.No: R25157445 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599
