About No deviation
At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.
We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why 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.
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.
