Quality Assurance Associate

Job Description:

• Contribute to Life Science projects for Antaes Asia clients
• Review and verify executed component batch records for accuracy and compliance with GMP/GDP requirements.
• Perform timely release of raw materials, buffers, and media in SAP in accordance with approved specifications and procedures.
• Support Electronic Batch Record (EBR) review activities for production operations.
• Participate in Quality on the Floor (QOTF), GEMBA walks, and provide real-time guidance to operations personnel on documentation practices and GMP compliance.
• Assist in identifying and escalating documentation or process deviations during record review or shopfloor interactions.
• Collaborate cross-functionally with Production, QC, and Material Management teams to resolve discrepancies or issues related to material release and batch documentation.
• Support QA team in continuous improvement initiatives and data gathering for metrics and trend analysis.
• Contribute to the promotion of Antaes services on top of assistance provided to clients

Job Requirements:

• Diploma in Biomedical Engineering, Biotechnology, Life Science or equivalent
• 1 - 2 years of Quality Assurance/ Manufacturing within a GMP-regulated biologics or pharmaceutical environment.
• Familiarity with Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP).
• Exposure to SAP and Veeva Vault would be preferred
• Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills
• Excellent communication skills, both written and verbal, in English - to liaison with English speaking counterparts