Quality Assurance Executive | GMP & Quality Systems #HMS
Summary
Oversee pharmaceutical quality systems, ensure GMP compliance, and maintain regulatory documentation for a manufacturing-focused healthcare company in Singapore.
Quality Assurance Executive | GMP & Quality Systems
Passionate about Quality Assurance, GMP compliance, and pharmaceutical manufacturing? Join a dynamic team where you'll play a key role in maintaining quality systems, ensuring regulatory compliance, and driving continuous improvement.
π― Your Role
As a Quality Assurance Executive, you will support and enhance the company's Quality Management System (QMS), ensure compliance with GMP and regulatory requirements, and work closely with manufacturing and cross-functional teams to uphold product quality and compliance.
π Key Responsibilities
- Maintain and continuously improve the Quality Management System (QMS).
- Manage quality documentation, including SOPs, work instructions, specifications, forms, records, and quality reports.
- Ensure compliance with GMP, PIC/S, ICH, ASEAN Guidelines, FDA, and other applicable regulatory standards.
- Coordinate change control activities, including impact assessments, implementation, and timely closure.
- Support deviation investigations, root cause analysis, and CAPA implementation.
- Provide QA support to manufacturing operations and resolve quality-related issues.
- Prepare and review Annual Product Quality Reviews (APQR) and Management Review reports.
- Handle customer complaints, product recalls, returns, and counterfeit investigations.
- Review packaging artwork, specifications, and technical documents for compliance.
- Support equipment qualification, validation activities, machine testing, and trial runs.
- Monitor stability programmes and ensure Good Documentation Practices (GDP) and data integrity.
- Participate in quality improvement projects and support the implementation of electronic Quality Management Systems (eQMS).
Interested candidates, do submit your resume to : jocelynchan@recruitexpress.com.sg OR telegram @jocelynchan
Jocelyn Chan| Consultant | Recruit Express Pte Ltd (Healthcare & Lifescience)
Company EA Licence number : 99C4599
Personnel EA License: R1331820