Validation & Compliance Specialist

CUTE MARINE SERVICES PTE. LTD.; Singapore; On-site; SGD 90,000 - 150,000; Full time

Job summary

CUTE MARINE SERVICES PTE. LTD. seeks a senior specialist in Quality Management Systems to lead validation and data integrity initiatives. You will drive validation of computerized systems, review CAPA and deviation investigations, and coordinate documentation control across facilities.

You will partner with cross-functional teams to ensure GMP/GDP compliance and prepare for internal and external audits, incorporating latest regulatory expectations and best practices.

Qualifications

• Minimum 5 years in Quality Management Systems and proficient in leading Validation, Computerized Systems/SDLC, Change Management, Deviation Investigation, Data integrity, Audits and Compliance, Documentation Control, Training Management and CAPA management.
• Minimum bachelor's or master's degree in a related field.
• GMP & GDP Certification is a plus and regulatory guideline familiarity is required.

Responsibilities

• Hands-on experience with automated systems supporting manufacturing, IT, engineering and operations.
• Review and prepare process/production equipment validation and computer systems validation.
• Review and approve Data Integrity activities and training, including periodic reviews.
• Act as Validation Point of Contact for facilities, utilities and equipment documents.
• Train site personnel in validation, prepare for audits and investigations.
• Ensure compliance with USFDA, EU GMP, PDA, ISPE and other regulatory expectations.

Skills

Quality Management Systems

Validation

Computerized Systems/SDLC

Change Management

Manufacturing Quality

Deviation Investigation

Data integrity

Audits & Compliance

Documentation Control

Training Management

CAPA management

Education

Bachelor's or Master’s degree

Tools

GMP & GDP Certification

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 ,GAMP5, ISO, WHO etc