Job Title:
Quality Assurance Specialist
We are seeking a Quality Assurance Specialist to support day-to-day QA activities on-site.
Key Responsibilities:
* Participate in the cross-functional team managing production right first time at site.
* Review and approve batch, cleaning, and testing documentation.
* Ensure Laboratory Out-of-Specification (OOS) and process deviations are documented, assessed, and associated CAPA identified.
* Provide support to deviation investigations and process performance monitoring.
* Perform trending on deviations raised to identify improvement initiatives.
* Provide detailed knowledge of quality systems in place and ensure root cause is identified and corrective actions completed.
* Provide guidance on quality requirements to maintain validation status, including participation in process/product Risk Assessments.
* Provide feedback on re-occurring issues ensuring continuous improvement to systems/processes.
* Ensure changes controls raised are documented, assessed, and completed.
* Prepare Annual Process and System Reviews.
* Act as lead/team auditor to support internal GMP walkdown and scheduled audits.
* Participate in generating and communicating quality metrics.
* Creation, review, and approval of quality procedures as required.
Requirements:
* Degree or postgraduate qualification in Science, Pharmacy, or equivalent.
* Knowledge of Quality IT systems desirable (e.g., SAP, Trackwise).
* Spray drying experience desirable.
* Knowledge and demonstrated expertise in Lean/Continuous Improvement.
* Experience and knowledge of GMP Requirements for electronic/paper-free operations.
* Experience in High Potency Manufacturing desirable.
Essential Skills:
* Excellent written and oral communication skills.
* Organizes and delivers information appropriately.
* Interacts with people effectively.
* Uses sound judgment to make good decisions based on gathered and analyzed information.
* Adapts to changing work environments, priorities, organizational needs, and diverse people.
* Displays energy and enthusiasm.
* Maintains high productivity and self-direction.