Quality Operations Specialist

2 weeks ago

Tuas, Singapore NUSANTARA PRIME CONSULTING PTE LTD Full time

Quality Operations Associate must assist site management to oversee the quality system execution on the manufacturing and production areas at all times. The personnel are required to observe, document, discuss, and report quality adverse events related to the manufacturing of the product and are responsible to ensure highest quality and compliance of released batches.

**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, Electronic 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, Singapore

**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

**Job Type**: Contract
Contract length: 6 months

Pay: $3,000.00 - $5,000.00 per month

**Benefits**:

- Health insurance

Schedule:

- Monday to Friday

**Experience**:

- GMP/cGMP: 1 year (preferred)
- Electronic batch record: 1 year (preferred)
- QA/QC: 1 year (preferred)
- investigation process: 1 year (preferred)

Work Location: In person

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