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 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