Validation and Compliance Specialist

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

Responsibilities

• Hands-on experience and understanding of automated systems supporting manufacturing, IT infrastructure, Engineering and operations.
• Strong understanding and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, and 820 and local regulatory expectations.
• Promoting GMP awareness and a culture of continuous improvement and facilitating manufacturing process improvements, laboratory operational excellence and validation activities, including latest trends in validation and best practices.
• Assist in review and preparation of process/production equipment validation and computer systems validation
• Review and approval of all Data Integrity – related activities and training including periodic reviews and status report to management
• Improve and add to existic Data Integrity knowledge base, identify training requirements and serve as SME for the same
• Serve as Validation Point of Contact and thus review all validation/qualification documents related to facilities, utilities and equipment.
• Train all site personnel in validation area, provide training and prepare for both internal and external audit and investigations that follow
• Hands on Computerized Systems Validation GAMP5/21CFR

Requirements

• Minimum 5 years in Quality Management Systems and Proficient in leading Validation, Computerized Systems/SDLC, Change Management, Manufacturing Quality, Deviation Investigation, Data integrity, Audits and Compliance, Documentation Control, Training Management and CAPA management
• Minimum bachelor’s or master’s degree
• GMP & GDP Certificate is plus
• Well versed with Regulatory Guidelines – USFDA, EU GMP, PDA, PICS, 21CFR, BPE, ISPE, USP <1050>, GAMP5, ISO, WHO etc.