QA Systems Validation Specialist

Walker Cole International is supporting an exciting opportunity within a pharmaceutical manufacturing site in the appointment of a QA Systems and Validation Specialist on a 12-month contract basis.

This opportunity will play a key role in supporting quality systems and validation activities across facilities, utilities, laboratory, and manufacturing equipment within a GMP-regulated environment.

The role will focus on change control, validation oversight, and ensuring compliance with global regulatory standards, while supporting capital projects and ongoing site operations.

Key responsibilities:

• Assess changes for GMP compliance in line with site change control procedures across facilities, utilities, laboratory, manufacturing equipment, and control systems.
• Review and approve GMP design aspects of capital projects, including new facility builds, upgrades, and implementation of manufacturing equipment and support systems.
• Ensure quality systems are implemented and maintained in compliance with ICH Q7, EudraLex, 21 CFR, and site quality standards.
• Provide validation expertise to ensure alignment with current regulatory requirements, industry guidelines, and best practices.
• Review and approve qualification and validation documentation, including protocols, reports, and associated data.
• Support validation activities including equipment, utilities, computer systems, and laboratory systems.
• Collaborate cross-functionally with Manufacturing, QC, Utilities, Engineering, and other site functions.
• Support new product introductions (NPIs) and other validation-related projects.
• Participate in additional quality systems and validation projects as directed.

Required experience and skills:

• Degree (BSc/BEng) in Chemistry, Engineering, or a related scientific discipline.
• Minimum of 5 years’ experience within the pharmaceutical industry, ideally in a QA or validation-focused role.
• Strong knowledge of GMP, change control, and documentation management systems.
• Understanding of validation principles across equipment, utilities, computer systems, and laboratory environments.
• Knowledge of regulatory requirements including Data Integrity and GMP standards.
• Familiarity with site functions such as QC, Operations, Engineering, and IT.
• Experience in project management or operational excellence is advantageous.
• Strong interpersonal, communication, and organisational skills.

Working pattern:
Full-time Onsite

Employment type:
Contract

Location:
The Randstad

Duration:
12 months

Keywords:
QA Systems | Validation Specialist | GMP | Change Control | Data Integrity | CSV | Qualification | Pharma | Life Sciences | Quality Systems | Validation

ID:
102253