Quality Operations Specialist

3 days ago


Singapore NUSANTARA PRIME CONSULTING PTE LTD Full time

**Responsibilities**:

- Main responsibilities include overseeing batch record review and incoming material quality audit
- Provide quality oversight of GMP manufacturing and manufacturing support, including technical operations, engineering, QC laboratory and supply chain activities
- Review completed incoming material inspection packages, Batch Records, Manufacturing Logs, product changeover/line-clearance activities and administration of Quality Logs, e.g., QA Hold, QA tag out
- Release incoming material, process, and product batches
- Participate in investigations arising out of non-compliance in incoming materials, QC testing, manufacturing processes, warehousing, and product
- Participate in change management, including change coordinator and/or QA oversight roles to ensure change plan is managed and complies with applicable policies
- Ensure site and global quality compliance
- All other responsibilities of QA Ops related.
- Any other task as assigned by Supervisor/Manager
- Based in Tuas

**About You**:

- Bachelor Degree with at least 1-2 years' experiences in pharma or biotech facility preferably familiar with biopharma QA Operations. Fresh graduates with GMP internship experience are welcome to apply
- Knowledge of quality management system, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a pharma or biotech facility
- Relevant QA Operations background from pharma or biotech environment is preferred
- Familiar with Health Authorities standards (e.g., FDA CFR and EU)
- Must be team player, meticulous, strong analytical and organizational skills

**Salary**: $3,000.00 - $5,000.00 per month

**Experience**:

- Quality and/or Compliance (GxP) environment: 2 years (preferred)



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