Senior Validation & Compliance Specialist, GMP & Regulatory

CUTE GREEN VENTURES PTE. LTD.; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

CUTE GREEN VENTURES PTE. LTD. is seeking a senior role focused on Quality Management Systems and Validation.

The candidate will lead validation efforts for computerized systems, equipment, and processes across manufacturing, IT, and operations, ensuring data integrity and regulatory compliance. The role demands experience with GMP/GDP, regulatory guidelines (USFDA, EU GMP, ISO), and the ability to train staff and prepare for audits and investigations.

Qualifications

• 5+ years leading Validation, Data Integrity and CAPA in QMS.
• Bachelor’s or Master’s degree required.
• GMP & GDP knowledge; familiarity with USFDA/EU GMP/regulations.

Responsibilities

• Hands-on experience with automated systems supporting manufacturing, IT, engineering and operations.
• Review and approve Data Integrity activities and prepare management status reports.
• Train site personnel in validation and be SME for validation activities.
• Coordinate validation/qualification documents for facilities, utilities and equipment.
• Prepare for internal and external audits and investigations.
• Support Computerized Systems Validation per GAMP5/21 CFR and related standards.

Skills

Quality management systems

Validation leadership

Data integrity

Audits & compliance

Documentation control

CAPA management

Change management

SDLC

GMP/GDP knowledge

Education

Bachelor’s or Master’s degree

Tools

GAMP5

21 CFR familiarity

Job description

CUTE GREEN VENTURES PTE. LTD. is seeking a senior role focused on Quality Management Systems and Validation.

The candidate will lead validation efforts for computerized systems, equipment, and processes across manufacturing, IT, and operations, ensuring data integrity and regulatory compliance. The role demands experience with GMP/GDP, regulatory guidelines (USFDA, EU GMP, ISO), and the ability to train staff and prepare for audits and investigations.