Quality Assurance Specialist

3 weeks ago

Hengoed, Caerphilly County Borough, United Kingdom Norgine Full time
Quality Assurance Officer

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.
Main Tasks:
  • 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.
Relationships:

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.
Benefits:

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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