Quality Assurance Executive - Geylang - ref. o52358119

Job Descriptions:

• Maintain and continuously improve the Quality Management System (QMS).
• Serve as the document controller for the Quality Manual, Standard Operating Procedures, Specifications, Work Instructions, Forms, Charts, Records and Quality Reports.
• Ensure compliance with GMP, PIC/s, ICH, ASEAN Guidelines, FDA, and other regulatory requirements.
• Prepare the annual Product Quality Review Report and Management Review Reports.
• Manage and follow up on change controls.
• Conduct process deviation investigations and follow up on CAPA implementation for closure.
• Handle quality issues in manufacturing operations.
• Manage customer complaints, product recalls, returns, and counterfeits cases.
• Review and control artwork and drawings for packaging materials.
• Ensure machine testing, trial runs, qualifications, and validation meet compliance requirements.
• Monitor accelerated and real-time stability programs.
• Ensure that Good Documentation Practices and traceability are in place.
• Undertake any additional tasks as assigned from time to time.

Job Requirements:

• Degree in Pharmaceutical Science, Engineering, or a related field.
• At least 2 years of experience in quality assurance within the pharmaceuticals, manufacturing, or medical devices industries
• Strong knowledge of QMS (e.g. ISO 9001, cGMP) with hands-on experience in documentation control and implementation.
• Proven expertise in QA processes, including investigations, change control, CAPA management, audits, and process validation.
• Excellent follow-up, communication, and interpersonal skills
• Meticulous and well-organised, and detail-oriented.
• Proficient in Microsoft Office applications.

Working Hours: 5 days week (8.00am – 5.15pm)