Associate Director Quality Assurance, (Sterile/Biologics)

As a key member of the Quality Assurance team, you will provide critical shop-floor oversight for biologics manufacturing. You will ensure that all aseptic processes, documentation, and quality events align with global cGMP standards (FDA, EMA, and PIC/S) to guarantee the safety and purity of client products.

Location: Tuas Biomedical Park, Company shuttle bus is provided island

Key Responsibilities

1. Manufacturing Oversight & Sterile Assurance

• Provide on-site quality oversight to ensure biologics production complies with internal SOPs and international cGMP regulations.
• Perform Room Release after line clearance and confirm Critical Process Parameters (CPPs) during active production.
• Conduct CCTV footage reviews of aseptic manufacturing processes to verify grade-A zone interventions and compliance.
• Lead the review and approval of Aseptic Process Simulation (APS/Media Fill) protocols, risk assessments...