QA Shift Officer - 12 month FTC

Norgine; Hengoed; On-site; GBP 32,000 - 46,000; Full time

Job summary

Norgine is seeking a Quality Assurance Officer to provide independent QA oversight of manufacturing operations during shift activities, ensuring GMP compliance and alignment with Norgine standards. You will review batch documentation and support batch disposition while advising on quality issues.

This 12-month fixed-term contract with shift work requires experience in GMP environments, deviations, CAPA, change controls, risk assessment and data integrity.

Qualifications

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

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 disposition.
• Manage 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

Risk assessment

Documentation review

Data integrity

Education

Bachelor's degree in a scientific discipline

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 activities.
• Manage 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

Essential Experience

• 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

We're looking for someone who demonstrates our values every day:

• 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.

This advert summarises the key responsibilities of the role and is not exhaustive. Norgine may adjust responsibilities to meet business and organisational needs.

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.

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