CQV Consultant

NO DEVIATION PTE. LTD.; Singapore; Hybride; SGD 90 000 - 140 000; Plein temps

Résumé du poste

NO DEVIATION PTE. LTD. in Singapore seeks a CQV, Validation & Quality Consultant with a hybrid profile to support end-to-end commissioning, qualification, validation and quality assurance across pharma, biotech and medical device projects.

You will lead CQV activities, develop validation protocols, prepare QA documents, support regulatory compliance and collaborate with engineering, QA and digital teams to deliver compliant solutions.

Qualifications

• Bachelor's or master's degree in Engineering, Life Sciences or Pharmacy
• Minimum 3 years' CQV/validation/quality experience in pharma/biotech/medical devices
• Strong GMP knowledge and validation protocol experience
• Hands-on equipment/utilities qualification and CSV
• Excellent documentation and English communication
• Singapore/APAC experience is a plus

Responsabilités

• Lead and execute CQV for equipment, utilities, facilities and CSV
• Develop, review and execute DQ/IQ/OQ/PQ and cleaning/process validation
• Prepare and optimize QA documents (SOPs, reports, risk assessments)
• Support GMP/FDA/EMA/PIC/S or HSA Singapore regulatory compliance
• Manage client audits, inspections and remediation actions
• Collaborate with engineering, QA and digital teams for project delivery
• Advise on data integrity and participate in digital validation projects
• Provide technical expertise and training to client teams

Connaissances

CQV

Validation

Quality Assurance

Documentation

English Communication

Project Management

Formation

Engineering/Life Sciences/Pharmacy degree

Outils

GxP Systems

CSV & Qualification Docs

Description du poste

CQV, Validation & Quality Consultant (Hybride Profile) | Singapore

We are seeking a highly versatile CQV, Validation & Quality Consultant (Hybrid Profile) to join our team in Singapore. As a key member, you will deliver end-to-end support for commissioning, qualification, validation, and quality assurance activities across pharma, biotech, and medical device projects.

Your Responsibilities:

• Lead and execute Commissioning, Qualification & Validation (CQV) activities for equipment, utilities, facilities, and computerized systems (CSV)
• Develop, review, and execute validation protocols (DQ, IQ, OQ, PQ), cleaning and process validation
• Prepare and optimize Quality Assurance documents (SOPs, technical reports, risk assessments)
• Support regulatory compliance with GMP, FDA, EMA, PIC/S, and HSA Singapore standards
• Manage and support client audits, regulatory inspections, and remediation actions
• Collaborate with engineering, QA, and digital teams to ensure successful project delivery
• Advise on data integrity and participate in digital transformation/validation projects
• Provide technical expertise and training to client teams

Your Profile:

• Bachelor’s or Master’s degree in Engineering, Life Sciences, Pharmacy or related field
• Minimum 3 years’ experience in CQV, validation and quality roles within pharmaceutical, biotech, or medical device environments
• Solid knowledge of GMP, regulatory requirements, quality systems, and validation protocols
• Proven hands-on experience with equipment/utilities qualification and CSV
• Strong documentation, problem-solving, and communication skills in English
• Adaptable, collaborative, and proactive mindset; able to manage multiple projects
• Experience in Singapore/Asia-Pacific region is an advantage