Job Title: Quality Assurance Specialist
In this pivotal role, you will be responsible for ensuring the quality of our products and processes. Your meticulous approach to documentation, coupled with your analytical skills, will enable you to identify areas for improvement and implement corrective actions.
Key Responsibilities:
* Review and assess batch, cleaning, and testing documentation
* Document and address Laboratory Out of Specification (OOS) and process deviations
* Support deviation investigations and process performance monitoring
* Identify root causes and implement corrective actions
* Maintain validation status through quality requirements
* Ensure continuous improvement through feedback on recurring issues
* Document and complete changes controls
* Create, review, and approve quality procedures
Required Skills and Qualifications:
* Degree or post-graduate qualification in Science, Pharmacy, or equivalent
* Knowledge of Quality IT systems desirable
* Spray drying experience desirable
* LLean/Continuous Improvement expertise
* GMP Requirements for Electronic/Paper-Free Operations experience
* High Potency Manufacturing experience desirable
This is an exciting opportunity for a detail-oriented professional to join our team and contribute to the success of our organization.