Position Summary
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.
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Key Responsibilities
Quality Systems & Change Control
* Assess GMP impact of changes in accordance with site Change Control procedures for:
o Facilities and utilities
o Laboratory and manufacturing equipment
o Control and automation systems
* Ensure changes are appropriately evaluated, documented, and approved for GMP compliance.
Validation & 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:
o Regulatory requirements
o SOPs
o 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)
Capital Projects & Design Review
* Review and approve GMP-relevant design aspects of major capital projects, including:
o New facility construction
o Facility upgrades
o New manufacturing equipment and support systems
Cross-Functional Collaboration
* 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.
Regulatory & Quality Standards
* Ensure quality systems are implemented and executed in compliance with:
o ICH Q7
o EudraLex
o 21 CFR requirements
o Site Quality standards
* Support data integrity initiatives, including compliance with GMP data integrity requirements and regulatory expectations.
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Skills & Competencies
* 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
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Minimum Requirements
* 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