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
