Role Summary
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, and result verifications.
2. Documentation & Batch Release
- Review and approve technical manufacturing documents, including PFDs, Master Batch Records (MBRs), and executed Batch Production Records (BPRs).
- Audit electronic data from production equipment, facility monitoring systems, and laboratory instruments.
- Oversee the review and approval of GMP drawings and SOPs; draft or revise Quality-specific SOPs to ensure continuous compliance.
3. Quality Systems & Compliance
- Initiate, investigate, and approve Quality Events, including Deviations, Change Controls, and CAPAs.
- Apply Quality Risk Management (QRM) principles to assess configuration changes and computer system events.
- Manage the Acceptable Quality Level (AQL) inspection process during Visual Inspection stages.
- Oversee specialized quality programs, including Site Pest Control management.
4. Audit & Client Management
- Support internal site audits and external regulatory inspections (e.g., HSA, FDA, EMA).
- Participate in Product Quality Reviews (PQR) and provide technical quality support for assigned client projects in the CDMO workflow.
Requirements
- Bachelor's degree or higher in Pharmacy, Microbiology, Biotechnology, Biomedical Science, or a related life sciences field.
- Minimum 6 - 8 years in pharmaceutical production or quality management with 3 years of direct experience in QA Oversight for biologics or sterile dosage forms.
- Regulatory Knowledge: Deep familiarity with global GMP regulations (e.g., US FDA 21 CFR, EU GMP Annex 1, and PIC/S Guides).
- Strong understanding of sterile manufacturing, aseptic techniques, and environmental monitoring.
- Proven ability to troubleshoot complex quality issues and coordinate corrective actions.
- Strong planning and prioritization of activities without supervision.
