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QA Validation

No deviation Pte Ltd

Singapore

On-site

SGD 20,000 - 60,000

Full time

Yesterday
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Job summary

A dynamic engineering consultancy in Singapore is seeking a QA Validation professional to provide quality oversight and ensure compliance with GMP in validation activities. The ideal candidate will have a Diploma or Bachelor's degree and 3–8+ years of experience in QA Validation within GMP-regulated environments. This role involves reviewing validation documentation, supporting audits, and ensuring validation activities adhere to regulatory guidelines. Join us to make a real difference in the pharmaceutical industry while advancing your career.

Benefits

Generous Leave Policy
Comprehensive Health & Wellness Coverage
Professional Development Opportunities
Inclusive Culture

Qualifications

  • 3–8+ years of experience in QA Validation or Quality Assurance within GMP-regulated environments.
  • Hands-on experience reviewing validation documentation for process equipment and cleanrooms.
  • Strong understanding of GMP and validation lifecycle concepts.

Responsibilities

  • Provide QA oversight for validation activities.
  • Review validation strategies and documentation.
  • Support internal and regulatory inspections.

Skills

QA oversight
Regulatory compliance
Documentation review
Stakeholder engagement
Detail-oriented

Education

Diploma or Bachelor's degree in Science, Engineering, Pharmacy, Biotechnology

Tools

Computer System Validation (CSV)
Job description
About No deviation

No deviation is dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. We are a dynamic engineering consultancy in Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, seeking individuals excited to contribute to impactful projects and drive innovation.

We believe that Empathy, Integrity, and Transparency guide our actions. We foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

The QA Validation professional provides quality oversight, review, and approval of validation and qualification activities to ensure compliance with GMP, regulatory expectations, and internal quality systems. This role ensures that validation deliverables are scientifically sound, risk-based, and inspection-ready, while supporting cross-functional project execution in a GMP-regulated environment.

Key Responsibilities
  • Provide QA oversight for equipment, facility, utility, process, and cleaning validation and qualification activities
  • Ensure validation approaches align with GMP, data integrity principles, and regulatory guidelines (e.g., FDA, EMA, PIC/S).
  • Review validation strategies to ensure compliant, risk-based execution.
  • Review and approve validation lifecycle documentation, including:
    • Validation Master Plan (VMP)
    • Risk assessments (e.g., FMEA, SRA)
    • URS, DQ, IQ, OQ, PQ
    • Cleaning validation protocols and reports
  • Computer System Validation (CSV) documents, where applicable
  • Ensure validation documentation is complete, traceable, and audit-ready
  • Review and assess validation-related deviations, non-conformances, and investigations
  • Ensure appropriate root cause analysis and CAPA implementation
  • Support change control activities and assess validation impact
  • Support internal, customer, and regulatory inspections related to validation scope
  • Act as a QA validation subject matter representative during audits
  • Support timely closure of validation-related audit observations
  • Collaborate closely with Engineering, CQV, Manufacturing, QC, IT, and external vendors
  • Provide QA guidance during project phases, including new equipment introduction, upgrades, and revalidation
  • Support project timelines while maintaining compliance
  • Contribute to continuous improvement of validation and QA processes
  • Support updates to SOPs, templates, and validation standards
  • Promote a strong quality culture and right-first-time mindset
Required Qualifications
  • Diploma or Bachelors degree in Science, Engineering, Pharmacy, Biotechnology, or a related discipline
  • 3–8+ years of experience in QA Validation, CQV, or Quality Assurance within GMP-regulated environments
  • Hands-on experience reviewing validation documentation for:
    • Process equipment
    • Utilities (e.g., WFI, clean steam, compressed gases)
    • Facilities and cleanrooms
    • Cleaning validation
  • Experience with Computer System Validation (CSV) is an advantage
  • Strong understanding of GMP, data integrity, and validation lifecycle concepts
  • Familiarity with FDA, EMA, and PIC/S regulatory expectations
  • Strong documentation review and compliance mindset
  • Ability to challenge constructively while enabling project delivery
  • Good stakeholder engagement and communication skills
  • Detail-oriented, structured, and inspection-focused
  • Comfortable working in project-based and fast-paced environments
Why join us?
  • Generous Leave Policy
  • Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs
  • Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company
  • Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated
  • Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career
How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

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