QA Shift Officer - 12 month FTC

Norgine; Hengoed; On-site; GBP 35,000 - 48,000; Full time

Job summary

Norgine, a leading pharmaceutical company, is seeking a Quality Assurance Officer to provide independent QA oversight of manufacturing operations during shift activities. You will ensure GMP compliance, review batch documentation, and support deviations, CAPAs, and change controls to safeguard patient safety.

This 12-month fixed-term contract with shift work offers the chance to contribute to an inspection-ready site, coach operations on quality standards, participate in audits, and maintain

Qualifications

• Experience in a GMP-regulated pharmaceutical, medical device, or similar environment.
• Understanding of GMP and Good Documentation Practice requirements.
• Familiarity with pharmaceutical quality systems including deviations, CAPA, change control, risk assessment, and document control.
• Experience analysing quality issues and supporting compliance-driven decisions.

Responsibilities

• Provide QA oversight across manufacturing, packaging, warehouse, engineering and related activities.
• Conduct shop-floor GMP inspections and support compliance monitoring.
• Assess quality issues and make timely, risk-based quality decisions.
• Review batch documentation and quality records to support batch disposition, deviations, CAPAs, change controls, and quality events.
• Promote GMP, Good Documentation Practice, and Data Integrity compliance.
• Coach and support operational teams on quality standards and best practices.
• Participate in audits and regulatory inspections, ensuring continued inspection readiness.
• Maintain effective communication and quality handovers between shifts.

Skills

GMP knowledge

Quality systems

Data integrity

GxP understanding

Education

Bachelor's degree in science

Tools

CAPA processes

Change control

Documentation review

Job description

Transforming Lives Through Quality

At Norgine, we have been bringing transformative healthcare solutions to patients for over a century. We are guided by our values to Drive performance, Dare to innovate, and Develop people and partnerships. If you're passionate about quality, collaboration, and making a meaningful impact on patient lives, we'd love to hear from you.

The Role

As a Quality Assurance Officer, you will provide independent quality oversight of manufacturing operations during shift activities, ensuring compliance with GMP, regulatory requirements, and Norgine standards. You will play a critical role in safeguarding product quality, supporting patient safety, and maintaining an inspection-ready environment while enabling efficient site operations.

12-Month Fixed-Term Contract (FTC) with Shift Working

Key Responsibilities

• Provide QA oversight across manufacturing, packaging, warehouse, engineering, and related operational activities
• Conduct shop-floor GMP inspections and support compliance monitoring
• Assess quality issues and make timely, risk-based quality decisions
• Review batch documentation and quality records to support batch disposition activitiesManage and support deviations, CAPAs, change controls, and quality events
• Promote GMP, Good Documentation Practice, and Data Integrity compliance
• Coach and support operational teams on quality standards and best practices
• Participate in audits and regulatory inspections, ensuring continued inspection readiness
• Maintain effective communication and quality handovers between shifts

Skills & Experience Required

• Experience within a GMP-regulated pharmaceutical, medical device, or similarly controlled environment
• Working knowledge of GMP and Good Documentation Practice requirements
• Understanding of pharmaceutical quality systems, including deviations, CAPA, change control, risk assessment, and document control
• Experience analysing quality issues and supporting compliance-driven decision-making

Preferred Qualifications

• Bachelor's degree, or equivalent qualification, in a scientific discipline
• Key Skills
• Quality assurance methodologies
• Risk management and problem solving
• Strong attention to detail
• Written and verbal communication
• Data management and documentation review
• Understanding of policies, procedures, and Health & Safety requirements
• Ability to work effectively in a fast-paced operational environment

What Success Looks Like At Norgine

• Drive - Takes ownership, delivers results, and makes decisions that matter
• Dare - Challenges constructively, embraces innovation, and acts with courage
• Develop - Collaborates effectively, values different perspectives, and helps others succeed

Why Join Norgine?

At Norgine, you'll be part of an inclusive environment where diverse perspectives are valued. You will have opportunities to develop your career while making a meaningful impact on patients' lives.
Bring your curiosity, creativity and drive. However you work best, you will find the support to succeed.

We are committed to building an inclusive workplace and welcome applications from all backgrounds.

AI Transparency Statement

To help us create clear and engaging job adverts, we may use AI-assisted drafting based on an approved job description. Every advert is reviewed and approved by our recruitment team before publication to ensure it accurately reflects the role and our organisation.

Benefits

Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.