The QA Systems & Validation Specialist is responsible for ensuring that all GMP-related changes, systems, and validation activities comply with regulatory requirements and site Quality standards.
This role provides subject matter expertise across change control, validation, and quality systems, supporting manufacturing, laboratory, engineering, and IT operations within a regulated pharmaceutical environment.
Assess GMP impact of changes in accordance with site Change Control procedures for:
Facilities and utilities
Laboratory and manufacturing equipment
Control and automation systems
Ensure changes are appropriately evaluated, documented, and approved for GMP compliance.
Provide validation expertise to ensure compliance with current industry regulations, guidelines, and best practices.
Review and approve master and executed qualification and validation documentation, including protocols, reports, and supporting data, ensuring conformance with:
Regulatory requirements
SOPs
Specifications and acceptance criteria
Validation activities include but are not limited to:
Qualification of premises, equipment, and utilities
Computer System Validation (CSV)
Laboratory equipment validation
Support of New Product Introductions (NPIs)
Review and approve GMP-relevant design aspects of major capital projects, including:
New facility construction
Facility upgrades
New manufacturing equipment and support systems
Work closely with Manufacturing, Quality Control, Utilities, Engineering, Automation, and IT teams.
Participate in cross-functional projects as directed by the Quality Systems & Validation Manager.
Ensure quality systems are implemented and executed in compliance with:
ICH Q7
EudraLex
21 CFR requirements
Site Quality standards
Support data integrity initiatives, including compliance with GMP data integrity requirements and regulatory expectations.
Strong interpersonal, communication, and presentation skills
Excellent organisational, time management, and multi-tasking abilities
Strong attention to detail and risk-based decision-making skills
Ability to work independently and collaboratively in a regulated environment
BSc or BE ngin Chemistry, Engineering, or a science-related discipline
Minimum 3 years’ pharmaceutical industry experience, ideally in a QA role
Experience with Change Control, documentation management, and GMP compliance
Knowledge or appreciation of site operations including QC, Manufacturing/Operations, Engineering, and IT
Familiarity with Data Integrity regulatory requirements
QA Systems and Validation Specialist • US
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