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QA CSV Specialist


  • 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 5 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

  • Willing to be placed in Tuas

Submit your resume to
Only shortlisted candidates will be contacted. 
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