QA Csv Specialist

2 days ago


Singapore NUSANTARA PRIME CONSULTING PTE LTD Full time

**Job description**:
**Responsibilities**:

- POC and coordinator for data integrity projects, ensure company’s quality requirements and agencies’ requirements are met.
- Quality oversight for automation qualifications (Delta V and BAS) and GMP equipment qualifications
- Review and approve of qualifications
- related documentations (protocols and reports)
- Ensure that the qualification strategy is sound and adhere to company standards and regulatory requirements.
- Review and approve SOPs
- Review and approve associated deviations
- Ensure that the appropriate Quality standards are applied consistent with internal Quality Standards and expectations.

**About You**:

- Bachelor Degree with at least 3 years' experiences in CSV QA validation preferably in biotech facility
- Knowledge of validation lifecycle, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a biotech facility
- Automation background from biotech environment who wants to venture as CSV QA validation
- Familiar with Health Authorities standards (e.g. FDA CFR and EU)
- Must be team player, curious with strong analytical and organizational skills

Note: Contract length 6 months to 12 months. Renewal opportunity.

Required to be based in Tuas.

All staff to observe MOH regulations and practices.

**Job Types**: Full-time, Contract
Contract length: 6-12 months

Schedule:

- Monday to Friday

Supplemental pay types:

- Overtime pay

COVID-19 considerations:
All staff to observe MOH regulations and practices.

**Experience**:

- CSV QA Validation: 3 years (preferred)


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