QA Csv Specialist

2 weeks 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.

Contract length: 6-12 months

**Salary**: $3,500.00 - $8,500.00 per month

Schedule:

- Monday to Friday

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

**Experience**:

- CSV QA validation: 3 years (preferred)
- Pharma Industry: 3 years (preferred)

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