Quality Assurance Specialist Role Overview
This is an exciting opportunity to join a dynamic environment and contribute to the continuous enhancement of quality and regulatory standards. As a Quality Assurance Specialist, you will play a crucial role in maintaining and enhancing the quality systems to ensure compliance with industry standards, regulatory requirements, and internal procedures.
Key Responsibilities:
* Support Compliance Efforts: Assist the Quality Manager and Qualified Person in ensuring adherence to Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Quality Systems, and both local and international regulations.
* Continuous Improvement Projects: Contribute to the development and execution of continuous improvement initiatives within the Quality Department, especially as the company grows its compounding services division.
* Quality Procedure Updates: Collaborate with operational staff to define and regularly update Quality Procedures, ensuring alignment with regulatory and industry standards.
* Quality Review Board Preparation: Gather and organize data for presentations and discussions at Quality Review Board meetings.
* Internal Audits: Participate in the auditing of GMP/GDP systems, ensuring corrective actions are effectively planned, implemented, and assessed for long-term effectiveness.
* Training & Compliance: Educate personnel on updated GMP/GDP documentation and ensure understanding of the Quality Management System (QMS).
* Incident Reporting: Document, investigate, and report any deviations or incidents to the Quality Manager and Qualified Person, helping to resolve issues promptly.
* Risk Management: Assist in risk assessments and the development of countermeasures with relevant process owners.
* Supplier Audits: Conduct audits and assessments of suppliers to ensure compliance with quality standards.
* Technical Agreement Management: Oversee the management and updates of Technical Agreements to ensure they remain current.
* Change Control Management: Handle documentation and execution of change control processes, ensuring completion and compliance.
* Stability Monitoring: Oversee the stability schedule and manage data related to stability, supporting accurate expiry dates.
* Complaint Management: Coordinate and investigate customer and supplier complaints, including compiling reports and identifying trends.
* Product Recalls: Assist with the coordination and documentation of product recalls, including conducting mock recalls.
* Support Regulatory Activities: Provide support for Pharmacovigilance, Medicovigilance, and overall compliance as needed.
* Protocol Management: Issue protocol and report numbers while maintaining associated logs.
* Report Compilation: Prepare and deliver reports within designated timeframes.
* Resource Allocation for Investigations: Ensure that necessary resources are assigned to investigations and that sufficient information is obtained.
* Corrective & Preventive Actions: Monitor the implementation, closure, and effectiveness of Corrective and Preventive Actions (CAPAs).