QA Data Integrity & Laboratory Compliance Consultant

Overview

An international pharmaceutical organisation is seeking an experienced QA Data Integrity & Laboratory Compliance Consultant to support laboratory compliance activities across a GMP-regulated environment. This position will work closely with Quality Assurance, Compliance, and Laboratory Operations teams to strengthen inspection readiness, ensure robust data integrity practices, and drive compliance across analytical testing activities.

The consultant will play a critical role reviewing analytical data packages, identifying compliance risks, supporting GMP oversight activities, and ensuring laboratory processes remain aligned with internal procedures and regulatory expectations. This opportunity would suit individuals with strong experience within pharmaceutical QC laboratories, laboratory compliance, data integrity, GMP auditing, or QA oversight functions.

Key Responsibilities

Data Integrity & Documentation Review

• Perform independent reviews of analytical data packages including release testing, stability studies, method validation, and laboratory investigations.
• Verify data accuracy, completeness, traceability, and compliance with GMP and data integrity requirements.
• Identify discrepancies, inconsistencies, documentation deficiencies, and potential compliance risks.
• Escalate findings appropriately and support resolution activities with laboratory and quality stakeholders.
• Ensure analytical records and supporting documentation meet regulatory expectations and internal quality standards.

Laboratory Compliance Support

• Support the Compliance Team in monitoring and maintaining GMP compliance across laboratory operations.
• Assist with implementation and execution of laboratory compliance programmes.
• Participate in compliance monitoring activities and laboratory walk-throughs.
• Support QA check rounds and routine laboratory quality oversight activities.
• Monitor adherence to established procedures, quality systems, and regulatory requirements.

Inspection Readiness

• Support inspection readiness initiatives across laboratory functions.
• Conduct documentation reviews and readiness assessments.
• Ensure required records, procedures, and supporting evidence are complete, current, and inspection-ready.
• Assist with preparation for regulatory inspections, client audits, and internal quality assessments.
• Work collaboratively with laboratory personnel to address identified readiness gaps.

Quality Systems & Continuous Improvement

• Support compliance-related quality processes including:
  • Sample management
  • Training compliance
  • Non-conformance handling
  • Documentation management
  • Corrective and preventive actions
• Contribute to continuous improvement initiatives focused on compliance performance and laboratory quality systems.
• Support enhancement of data review procedures and compliance monitoring processes.
• Assist in strengthening laboratory controls and inspection preparedness programmes.

Stakeholder Support

• Provide guidance to laboratory personnel on:
  • GMP requirements
  • Data integrity principles
  • Good documentation practices
  • Compliance expectations
• Collaborate effectively with Quality Assurance, Compliance, QC Laboratories, and operational teams.
• Build strong working relationships across multiple functions to drive compliance outcomes.

Required Experience

• Master's degree in a Scientific Discipline (Chemistry, Pharmaceutical Sciences, Biotechnology, Biochemistry, Microbiology, or related field).
• Proven experience working within a GMP-regulated pharmaceutical or biotechnology laboratory environment.
• Strong understanding of:
  • GMP regulations
  • Data Integrity principles (ALCOA+)
  • Good Documentation Practices
  • Quality Systems
  • Laboratory compliance requirements
• Experience reviewing analytical documentation and laboratory records.
• Previous exposure to QC laboratories, stability testing, analytical testing, method validation, or laboratory investigations.
• Strong risk assessment and critical thinking capabilities.
• Ability to identify compliance gaps and drive appropriate actions.
• Strong organisational skills with the ability to manage multiple priorities and strict deadlines.
• Excellent written and verbal communication skills.
• Fluent English language skills.

Ideal Consultant Profile

The ideal consultant will have experience in one or more of the following areas:

• QA Data Integrity
• Laboratory Compliance
• QC Compliance
• GMP Auditing
• Quality Systems
• Quality Assurance Oversight
• Analytical Data Review
• Stability Programme Support
• Inspection Readiness
• Pharmaceutical Laboratory Operations

Key Skills

• GMP Compliance
• Data Integrity (ALCOA+)
• Analytical Data Review
• Quality Assurance
• Laboratory Compliance
• Regulatory Inspection Readiness
• Documentation Review
• Risk Assessment
• CAPA Support
• Change Control Awareness
• Deviation Awareness
• Root Cause Analysis
• Cross-Functional Collaboration
• Continuous Improvement

Why This Opportunity?

This assignment offers the opportunity to work at the intersection of Quality Assurance, Compliance, and Laboratory Operations, playing a key role in maintaining inspection readiness and ensuring the integrity of analytical data within a highly regulated pharmaceutical environment. The successful consultant will have significant visibility across quality and laboratory functions while contributing directly to GMP compliance and operational excellence initiatives.