Quality Assurance Specialist
The Role:
* 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 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 carried out in line with same.
* Support development and implementation of improved quality reporting measures.
* Liaise with 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, e.g., area clearances, batch record reviews, aseptic operations.
* Provide quality input into decision-making processes on the shop floor to maintain product quality.
* 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 like change controls where applicable.
Required Skills & Qualifications:
* Excellent communication and problem-solving skills.
* Ability to work effectively in a team environment.
* Strong analytical and critical thinking skills.
* Familiarity with quality management systems and regulatory requirements.
Benefits:
* Opportunity to work in a dynamic and innovative industry.
* Chance to develop your skills and expertise in quality assurance.
* Collaborative and supportive work environment.