Senior Quality Officer - Shift Lead

Because at Norgine, we transform lives with innovative healthcare solutions.

We have an exciting opportunity for a Senior Quality Officer - Shift Lead to join Norgine.

The person holding this position will report to the Senior Quality Assurance Manager and be a member of the Quality Team.

Working a 4-shift pattern (4 on 4 off) of 12 hours per shift.

Main Purpose

• Work closely with Production leadership to offer advice and support on any quality-related issues to ensure GMP compliance.
• Maintain, support, and improve the QMS employed with Norgine, Hengoed, promoting continuous improvements while maintaining compliance with regulations and standards for medicinal products and medical devices.
• Support the QP in executing their legal and routine duties.
• Assist in the batch documentation review process.
• Provide validation advice and support to site initiatives as required.
• Support delivery of site Quality objectives and broader business goals.

Key Responsibilities & Accountabilities

• Monitor production processes for GMP compliance, conduct inspections and audits.
• Maintain accurate records of quality checks, deviations, and corrective actions; review batch records, SOPs, and product specs.
• Provide training to production staff on quality standards and GMP compliance.
• Investigate non-conformities and quality issues; document findings and coordinate CAPAs.
• Collaborate with cross-functional teams to ensure quality objectives are met and continuous improvement initiatives are supported.
• Assist in preparing for external audits and inspections, ensuring compliance with industry regulations.
• Monitor quality metrics, analyze trends, and recommend process improvements.

Main Tasks

• Perform batch review delegated from the QP.
• Identify, assess, investigate, and report Quality incidents.
• Provide advice and training on GMP, ISO standards, validation, and auditing.
• Maintain oversight of Quality compliance via key indicators.
• Review and approve Quality-related documents.
• Lead and support projects for continuous improvement.
• Prepare Quality documentation such as GMP training, reports, validation summaries.
• Maintain expertise in Quality, legislation, and processes to support equipment and process improvements.
• Ensure health and safety compliance.

Relationships

Maintain excellent working relationships across all departments at the Hengoed site.

Skills & Knowledge

• A degree or equivalent in science or engineering preferred.
• Relevant pharmaceutical Quality experience.
• Line management experience.
• Strong communication and supervisory skills.
• Project coordination and reporting skills.
• Self-motivation, attention to detail, influencing skills, and audit capability.

Benefits

Benefits vary by location; please consult the Norgine TA representative for details.

If you're interested, learn more about your potential career with Norgine and apply here.

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