Quality Specialist

Warman O'Brien; Slough; Hybrid; GBP 40,000 - 60,000; Full time

Job summary

Warman O’Brien is seeking a Quality Specialist to maintain and continuously improve the Quality Management System in a GxP environment. The role focuses on Deviations, CAPAs, audits and supplier qualifications to ensure regulatory compliance.

Ideal candidates have a life sciences background and 5+ years in pharma quality, with attention to detail and the ability to work independently and collaboratively.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• 5+ years’ experience in a pharmaceutical Quality role preferred.
• GDP experience advantageous.
• Strong organisational, communication and problem-solving skills.

Responsibilities

• Manage and maintain quality records including Deviations, Change Controls, Complaints and CAPAs.
• Provide Quality support to cross-functional stakeholders across GxP activities.
• Identify quality risks and improvement opportunities and support corrective actions.
• Monitor and trend quality metrics and support Management Reviews.
• Coordinate Annual Product Quality Reviews and local stability programmes.
• Maintain Quality training curricula and ensure training completion and effectiveness.
• Support product traceability, returns, recalls and falsified product processes.
• Support self-inspections, audits, regulatory inspection readiness and follow-up actions.
• Oversee local vendors, including qualification, Quality Agreements, audits and monitoring.
• Support customer and supplier qualification activities.
• Ensure GxP documentation is accurately maintained within electronic quality systems.

Skills

Quality Management

GxP Compliance

CAPA handling

Deviation management

Audit support

Regulatory liaison

Cross-functional collaboration

Documentation

Education

Bachelor's degree in Life Sciences

Tools

Quality Management Software

Electronic Quality Systems

Quality Metrics/Analytics

Job description

Hybrid working (up to 3 days per week onsite in Berkshire)

About the Role

We are seeking a Quality Specialist to support the maintenance and continuous improvement of the Quality Management System and ensure compliance with applicable GxP requirements.

Key Responsibilities

• Manage and maintain quality records, including Deviations, Change Controls, Complaints and CAPAs.
• Provide Quality support and guidance to cross-functional stakeholders across GxP activities.
• Identify quality risks and improvement opportunities and support appropriate corrective actions.
• Monitor and trend quality metrics and support Management Reviews.
• Coordinate Annual Product Quality Reviews and local stability programmes.
• Maintain Quality training curricula and ensure appropriate training is completed and effective.
• Support product traceability, returns, recalls and falsified product processes.
• Support self-inspections, audits, regulatory inspection readiness and follow-up actions.
• Oversee local vendors, including qualification, Quality Agreements, audits and ongoing monitoring.
• Support customer and supplier qualification activities.
• Ensure GxP documentation is accurately maintained within electronic quality systems.

About You

• Bachelor’s degree in Life Sciences, such as Biology, Chemistry or Pharmacy.
• Ideally 5+ years’ experience in a pharmaceutical Quality role.
• GDP experience is advantageous.
• Strong organisational, communication and problem-solving skills.
• Ability to work independently and collaboratively.
• Excellent attention to detail and ability to manage complex situations.