QA Analyst

The QA Analyst will be responsible for ensuring the quality and compliance of pharmaceutical products through various stages of manufacturing testing and distribution. This role involves implementing and maintaining quality systems conducting audits and providing support for regulatory inspections.
Review and approve documents related to manufacturing packaging labeling and testing to ensure compliance with regulatory standards (e.g. FDA EMA).
Conduct batch record review and release activities in accordance with standard operating procedures (SOPs).
Monitor and evaluate manufacturing processes to identify and address quality issues and deviations.
Implement and maintain quality management systems including document control change control and CAPA (Corrective and Preventive Action) systems.
Develop and update SOPs protocols and other qualityrelated documents as needed.
Facilitate training programs to ensure staff compliance with quality standards and procedures.
Conduct internal audits to assess compliance with GMP (Good Manufacturing Practices) and other regulatory requirements.
Coordinate external audits and inspections by regulatory agencies and customers.
Collaborate with crossfunctional teams to address audit findings and implement corrective actions.
Identify opportunities for continuous improvement in quality processes and systems.
Participate in quality risk assessments and develop risk mitigation strategies.
Support validation activities for equipment processes and analytical methods.