Senior Quality Officer - Shift Lead

Want a 3D Career? Join Norgine. At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community. We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits. Bring everything about yourself that you're proud of, whether that's your passion for making a difference, focus on others' well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community. In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people's wellness as much as you do. Because at Norgine, we transform lives with innovative healthcare solutions.

The person holding this position will report to 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 issue to ensure compliance to GMP.
• Maintain, support and improve the QMS employed with Norgine, Hengoed and to promote continuous improvements, whilst maintaining compliance with regulations and standards for medicinal product and medical devices.
• To support the QP in the execution of their legal and routine duties.
• To support the batch documentation review process.
• Ensure the provision of validation advice and support to site initiatives as required.
• Supporting delivery of site Quality objectives and support of wider business objectives.

KEY RESPONSIBILITIES & ACCOUNTABILITIES:

• Quality Assurance: Monitor production processes to ensure compliance with established GMP protocols and quality standards. Conduct regular inspections and audits of production areas and equipment.
• Documentation & Reporting: Maintain accurate and comprehensive records of quality checks, deviations, and corrective actions. Prepare and review quality-related documentation, including batch records, SOPs, and product specifications.
• Training & Support: Provide on-the-job training to production staff on quality standards and GMP compliance. Support the implementation of quality initiatives across the production team.
• Deviation Management: Investigate non-conformities and quality issues; document findings and coordinate corrective and preventive actions (CAPAs) with relevant stakeholders.
• Collaboration: Work closely with cross-functional teams, including Production and Engineering to ensure alignment on quality objectives and to facilitate continuous improvement initiatives.
• Compliance Oversight: Assist in the preparation for external audits and inspections. Ensure all quality practices are in line with industry regulations and company policies.
• Trend Analysis: Monitor quality metrics and analyse trends to identify opportunities for process improvements. Provide recommendations to enhance product quality and operational efficiency.

MAIN TASKS:

• To perform batch review as a delegated duty from the QP.
• To assist and facilitate the identification, assessment, investigation and reporting of Quality incidents.
• To provide advice and training on all Quality related matters including but not limited to GMP, ISO standards, validation, and auditing.
• To maintain an overview of Quality compliance through the effective use of key indicators.
• To review and approve Quality related documents for the site.
• Lead, participate and support projects to enable continuous improvements.
• Preparation of Quality related documentation, including but not limited to the SMF, GMP training, monthly and quarterly reports, validation summaries.
• To maintain expertise and current knowledge of all areas of Quality, relevant legislation and production processes to fully support maintenance and improvements of equipment and processes, providing advice as required.
• Comply with all statutory and company requirements for health and safety.
• The above list is not exhaustive and the job holder may be expected to perform other reasonable tasks within the boundaries of their skills, in the interest of the job and the company's performance.

RELATIONSHIPS: Maintains excellent working relationships with all departments across Hengoed site.

Skills & Knowledge:

• A degree or equivalent in a science or engineering subject is preferred.
• A minimum of 5 years relevant experience in a Quality environment in the pharmaceutical industry.
• Line management experience.
• Strong communication and supervisory skills are essential.
• The ability to introduce, co-ordinate, complete and report on projects.
• A high level of self-motivation is necessary.
• Attention to detail.
• Able to rationally persuade.
• Influencing skills.
• Ability to perform audits, internally and externally.

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

Sound good? Find out more about the career you'll have with Norgine, then apply here.