Quality Assurance Specialist - Pharma
With worldwide demand for life-changing oncology treatments increasing, one of our global pharmaceutical clients is seeking a Quality Assurance Specialist to support multiple capital projects onsite.
This is a fantastic opportunity to work on a state-of-the-art fill-finish facility and the company's first stand-alone vaccine and biologics plant outside the US.
Role Summary:
* Review and approval of all manufacturing batch documentation including electronic batch records, real-time reports, master data using site systems.
* Review and approval of SOPs, cleaning verification/validation data, and other documents as necessary for the IPT department.
* Drive effective writing/revising/rolling out of accurate operational procedures, training materials, and maintenance procedures for various quality-related systems; ensure all work is subsequently carried out in line with same.
* Support the development and implementation of improved quality reporting measures.
* Liaise with Quality Specialists/QP/QA Lead to resolve queries relating to batch manufacturing processes.
* Provide effective real-time on-floor support for day-to-day manufacturing operations, e.g., area clearances, batch record reviews, aseptic operations.
* Provide quality input into decision-making processes on the shopfloor ensuring product quality is maintained.
* Provide training in all aspects of quality management systems and GMP.
* Ensure all work is carried out in line with SOPs, training, or other quality systems such as change controls where applicable.
* Facilitate compliance direction for the site by assisting in adherence to divisional policies and guidelines as well as regulatory requirements.
Experience, Knowledge & Skills:
* Relevant experience in a quality role, ideally in a pharmaceutical manufacturing environment.
* Knowledge of US and European cGMP guidelines, and other international regulatory requirements, as applicable to the site.
* GMP Audit experience in the pharmaceutical industry.
* Third-Level Degree qualified in a Science/Technical or related discipline.