Job Title: Quality Assurance Specialist
Company Overview: Our client is a global pharmaceutical company with a presence in multiple countries.
Role Summary: The Quality Assurance Specialist will play a crucial role in supporting multiple capital projects taking place onsite. This includes reviewing and approving manufacturing batch documentation, SOPs, cleaning verification/validation data, and other documents as necessary. The specialist will also drive effective writing and revising of operational procedures, training materials, and maintenance procedures for various quality-related systems.
* 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/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 the Quality Specialists/QP/QA Lead to resolve queries relating to batch manufacturing process.
* Provide effective real-time on-the-floor support for day-to-day manufacturing operations, such as area clearances, batch record reviews, and aseptic operations.
* Provide quality input into decision-making processes on the shop floor, 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.
Requirements:
1. Relevant experience in a quality role, ideally in a pharmaceutical manufacturing environment.
2. Knowledge of US and European cGMP guidelines and other international regulatory requirements, as applicable to the site.
3. GMP audit experience in the pharmaceutical industry.
4. Third-level degree qualified in a Science/Technical or related discipline.