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