Quality System Specialist 5WORKING DAYS #HKF
Location: Ubi
Salary: Up to $3,800/month
Working hours: Mon to Fri office hours
Key Responsibilities
- Ensure compliance with federal, state, local regulations, and internal policies.
- Conduct compliance assessments, including facility, equipment, and record inspections.
- Review SOPs, protocols, batch records, and quality documents (deviations, CAPAs, etc.).
- Support regulatory inspections and client audits by preparing relevant documentation and responses.
- Contribute to corrective and preventive action (CAPA) recommendations.
- Conduct internal facility inspections and maintain audit records.
- Assist with reagent release activities and review of customer test reports.
- Participate in the analysis of quality metrics via QMS and support Quality Management Reviews (QMRs).
- Engage in process improvements, internal QA projects, and basic regulatory training.
- Audit subcontractors, vendors, and suppliers, as needed.
- Respond to customer regulatory inquiries in a timely manner.
Required Qualifications
- Min. Bachelor’s degree, preferably in a life science discipline.
- Min 2 years in a Quality Assurance role in a regulated environment (GLP/GMP/ISO preferred).
- Strong verbal and written communication skills
- Exceptional attention to detail
- Proficient in Microsoft Office
- Ability to work independently and follow instructions
If interested, please email me at Kellyn@recruitexpress.com.sg or telegram @kellynlytan
Kellyn Fullviana
(CEI.No: R25157445 | Recruit Express Pte Ltd (Healthcare & Life Science))