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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