We are seeking a dedicated and experienced Quality Assurance Specialist to oversee quality operations at our manufacturing facility. This role is ideal for a proactive and detail-oriented individual with a background in quality assurance, preferably within the pharmaceutical or graphics industry.
Key Responsibilities:
* Lead and manage site quality documentation and quality systems.
* Provide support to the production department on quality-related topics.
* Oversee and approve production batches (delegated to Quality Control).
* Manage internal and external deviations and CAPA plans.
* Conduct risk assessments and drive continuous improvement projects.
* Lead process validations and change management activities.
* Execute internal and supplier audits; participate in third-party audits.
* Monitor and report on KPIs; analyse data and implement improvement actions.
* Train other departments on quality procedures and tools.
* Oversee measuring instruments management.
Requirements:
* Minimum 3 years' experience in a Quality role, preferably within GMP, pharmaceutical, or graphic industries.
* Third level quality-related degree or relevant to the relevant industries above.
* Knowledge of ISO 9001, GMP requirements, ISO 19011.
* Experience with risk analysis, CAPA, and documentation systems.
* Lean Manufacturing, 8D reporting, and project management are preferred.
* Proficiency in Microsoft Word, Excel, email platforms, and ERP systems.