Quality Assurance Specialist
3 weeks ago
Norgine is seeking a highly motivated and detail-oriented Quality Assurance Officer to join our team. As a Quality Assurance Officer, you will play a critical role in ensuring the quality and compliance of our medicinal products and medical devices.
Key Responsibilities:- Review batch documentation and deviations to ensure compliance with regulations and standards.
- Maintain and improve the Quality Management System (QMS) to promote continuous improvements and compliance.
- Manage and perform internal self-inspections and external audits, including vendors and suppliers.
- Support the Quality Person (QP) in their legal and routine duties.
- Maintain key quality documents, including the site master file and inspection evidence files.
- Coordinate and perform investigations related to product quality complaints and liaise with market Quality Management Representatives.
- Supply information for and coordinate the execution and review of the Product Quality Review process.
- Support the ONE Norgine model, particularly with regards to Global Quality.
- Deliver site quality objectives and support Global Quality objectives.
- Create Quality Agreements for commercial partners.
- Perform batch review, either as a delegated duty from the QP or as a QP, in support of the certification process.
- Assist and facilitate the identification, assessment, investigation, and reporting of quality incidents.
- Provide advice and training on all quality-related matters, including GMP, ISO standards, validation, and auditing.
- Maintain an overview of quality compliance through the effective use of key performance indicators.
- Review and approve quality-related documents for the site.
- Support and facilitate internal and external inspections.
- Report quality-related KPIs to the site and globally.
- Lead, participate, and support projects to enable continuous improvements.
- Prepare quality-related documentation, including the site master file, GMP training, monthly, and quarterly reports.
- Maintain manufacturing site licenses.
Maintain excellent working relationships with all departments across the Hengoed site.
Liaise with other manufacturing sites within Norgine and through the External Network Structure.
Requirements:- A degree or equivalent in a scientific discipline is preferred, with experience in a Quality environment in the pharmaceutical industry.
- Strong communication skills are essential.
- The ability to introduce, coordinate, 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.
Our benefits may vary per location. Please liaise with the Norgine Talent Acquisition representative to obtain more information.
Norgine is a leading healthcare organization that transforms lives with innovative healthcare solutions. We offer a fully-rounded experience with no limits, where you can bring everything about yourself that you're proud of and unleash your intellectual curiosity in a fast-paced environment and supportive community.
At Norgine, we care about people's wellness as much as you do. We have an exciting opportunity for a Quality Assurance Officer to join our team and contribute to our mission of transforming lives with innovative healthcare solutions.
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