Quality Assurance Specialist Opportunity
We are seeking a Senior Quality Assurance Specialist to support multiple capital projects at our site in Ireland. This role offers a unique opportunity to work on state-of-the-art facilities and contribute to the company's first vaccine and biologics plant outside the US.
Key Responsibilities:
* Review and approve manufacturing batch documentation, including electronic records and real-time reports.
* Approve SOPs, cleaning verification/validation data, and other documents related to the IPT department.
* Develop and implement operational procedures, training materials, and maintenance procedures for quality-related systems.
* Support the development of improved quality reporting measures.
* Liaise with Quality Specialists to resolve queries related to batch manufacturing processes.
* Provide real-time support for day-to-day manufacturing operations.
* Ensure product quality is maintained through effective decision-making and input.
* Provide training in Quality Management Systems and GMP.
Experience, Knowledge & Skills:
* Relevant experience in quality roles, ideally in pharmaceutical manufacturing environments.
* Knowledge of cGMP guidelines and international regulatory requirements.
* GMP Audit experience in the pharmaceutical industry.
* Degree qualified in a Science/Technical or related discipline.