Job Description
- Performing visual inspections of white stock and finished products to ensure quality standards are met.
- Reviewing batch production records for compounding, filling, and packaging processes, ensuring all critical steps meet specifications prior to release.
- Assessing autoclave reports for compounding and filling operations.
- Conducting annual inspections of retention samples, including identification, segregation, and disposal, and maintaining the Retention/Reserve Sample Program.
- Approving Engineering Change Notices (ECNs) and managing updates to the Bill of Materials (BOM).
- Investigating and resolving deviations before batch release.
- Coordinating the review of alarm reports and supporting impact assessments for critical alarms.
- Supporting the preparation and administration of Master Documents such as SOPs, Forms, Templates, and MBRs.
- Assisting in the generation of Annual Product Quality Review (APQR) reports.
- Setting up finished goods inspection plans for new products in SAP.
- Tracking Master Batch Record (MBR) submissions and reporting weekly performance metrics.
- Conducting aseptic audits of manufacturing processes and facilities.
- Performing in-process checks and critical quality attributes during production shifts (e.g., IPC, IBA, line clearance approval).
- Maintaining 5S standards and good housekeeping in the Lot Release area.
- Monitoring key performance indicators (KPIs) and escalating issues as necessary.
- Collaborating cross-functionally to support quality operations and continuous improvement.
Requirements
- Minimum Diploma in Science, Engineering, or equivalent with at least 1-3 years of relevant experience in Quality Assurance within a manufacturing environment.
- Experience in GMP/GDP-regulated industries, such as pharmaceuticals or medical devices.
- Strong understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Experience with cleanroom operations is an advantage.
- Familiarity with MES and SAP systems is also preferred.
For interested candidates, please submit your latest resume to jacquelinefong@recruitexpress.com.sg
Jacqueline Fong Hsin Ting (R21103226)
Recruit Express Pte Ltd
Company Reg. No. 199601303W
EA License Number: 99C4599