Quality Assurance Specialist - Pharma Role
This is a 11-Month Contract opportunity to support multiple capital projects at 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, and 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, and rolling out of accurate operational procedures, training materials, and maintenance procedures for various Quality related systems.
* Support the development and implementation of improved quality reporting measures.
* Liaise with Quality Specialists, QP/QA Lead to resolve queries relating to batch manufacturing process.
* Provide real-time on-floor support for day-to-day manufacturing operations, such as area clearances, batch record reviews, and aseptic operations.
* Ensure product quality is maintained through quality input into decision-making processes on the shopfloor.
* Provide training in all aspects of Quality Management Systems and GMP.
* Facilitate compliance direction 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, applicable to the site.
* GMP Audit experience in the pharmaceutical industry.
* Third-level degree qualified in a Science/Technical or related discipline.