QA Shift Officer - 12 month FTC

Norgine B.V.; Cefn Hengoed; On-site; GBP 42,000 - 56,000; Full time

Job summary

Norgine B.V. is seeking a Quality Assurance Officer to provide independent QA oversight during shift activities, ensuring GMP compliance and adherence to Norgine standards. The role safeguards product quality and patient safety while enabling efficient site operations.

You will review batch documentation, support deviations and CAPAs, and promote data integrity. Join a team focused on excellence in pharmaceutical quality and regulatory readiness.

Qualifications

• 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.

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

Quality assurance methodologies

Risk management

Attention to detail

Written communication

Data management

Policies & Health & Safety

Education

Bachelor's degree in a scientific discipline

Job description

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.,

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

What Success Looks Like at Norgine

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.

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.