Specialized Staffing & Consulting for Life Sciences and Pharma & Connecting Talent Compliance and Innovation for Sustainable Growth

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Quality Assurance & Validation Staffing

Providing validation and QA experts for consistent, audit-ready processes.

Ensuring Quality, Compliance, and Reliability

Our validation staffing solutions ensure that IT systems, equipment, and processes meet the highest quality standards. With experts in CSV/CSA, QMS, and CAPA, we help organizations stay compliant and inspection-ready.

CSV/CSA and equipment qualification experts
QMS audits, SOP development, and CAPA support
Data integrity validation (ALCOA/ALCOA+)
Application and infrastructure validation
Let's Develop Together

Why Quality Assurance & Validation Staffing?

The most critical time to ensure compliance, efficiency, and reliability is before scaling operations. Our QA & validation staffing solutions provide you with skilled professionals who safeguard quality systems, regulatory readiness, and inspection success.

Process Validation

We provide experts to validate manufacturing processes, ensuring consistency, reproducibility, and compliance with FDA, EMA, and global standards.

Equipment Qualification

Our staff supports IQ, OQ, and PQ activities for equipment, utilities, and facilities, reducing risks and meeting GxP and Annex 11 requirements.

Computer System Validation

Specialized consultants ensure that your IT and lab systems meet CSV/CSA requirements, data integrity (ALCOA+), and 21 CFR Part 11 compliance.

Audit & Inspection Readiness

We deliver professionals skilled in preparing documentation, conducting internal audits, and supporting CAPA to keep you inspection-ready at all times.

We are a Full-Service QA Partner
From computer system validation to equipment qualification and QMS audits, we provide end-to-end staffing solutions that cover all aspects of quality assurance and validation needs.
Flexible Engagement Models
Whether you need short-term support for audits or long-term staffing for CSV, SOP management, or CAPA, our tailored agreements adapt to your business requirements and compliance timelines.
Compliance-Focused Expertise
Our consultants bring hands-on knowledge of FDA, EMA, Annex 11, and GxP frameworks, ensuring your operations remain inspection-ready, efficient, and globally compliant.
Our approach

How We Help You Ensure Compliance and Build Confidence

Through our experienced QA & validation professionals, we help organizations strengthen quality systems, meet regulatory requirements, and minimize compliance risks. Our approach ensures every process is reliable, inspection-ready, and aligned with global standards.

Validation Strategy & Planning
We design comprehensive validation strategies, covering CSV/CSA, equipment qualification, and infrastructure assurance, ensuring all activities meet FDA, EMA, and GxP requirements.
Process & System Documentation
Our experts support SOP creation, periodic reviews, audit trails, and QMS documentation, making sure processes are consistent, reliable, and audit-ready.
Risk & Gap Assessments
We perform in-depth assessments to identify vulnerabilities in quality and validation systems, recommending corrective and preventive actions (CAPA) for long-term compliance.
how it work?

Our Consulting Process

We provide specialized QA & Validation services, ensuring compliance, consistency, and long-term operational growth.

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1

Initial Assessment

We begin with in-depth discussions to understand your current quality systems, regulatory requirements, and staffing needs, ensuring alignment with industry standards.
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2

Resource Planning

Our experts design a tailored validation strategy and staffing plan, identifying qualified professionals for CSV/CSA, equipment qualification, or QMS documentation support.
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3

Validation Execution

Assigned experts perform validation activities, create SOPs, support CAPA, and conduct system checks, ensuring readiness for inspections and audits.
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4

Ongoing Compliance

We provide continuous monitoring, audit readiness training, and periodic reviews, ensuring your operations remain compliant and inspection-ready at all times.

Let’s Collaborate with Us!

    Let’s Collaborate with Us!

    Collaboration drives innovation. At ClinixHire, we work hand-in-hand with pharmaceutical, biotech, and life sciences organizations to deliver staffing and consulting solutions that ensure compliance, accelerate research, and power sustainable growth.
    Let’s Build Together