1. Oversees and coordinates the quality assurance (QA) program governing companies Laboratory Operations.
- Develops, interprets, and implements QA policies, manages quality systems, and facilitates regulatory compliance.
- Manages QA change control process, SOP preparation/revisions, and GMP training programs.
- Analyze data relating to process validations, process controls, and continuous process improvement efforts. Coordinate the necessary quality adjustments.
- Oversee the following investigations: nonconforming product, defects, customer complaint, laboratory out-of specification, and corrective and preventive action. Ensure all investigations are performed and closed in a timely fashion. Monitor and report adverse events.
- Review relevant GMP documents for compliance to company SOPs, quality systems, and regulatory requirements.
- Provide guidance, interpretation, support, training, and input on the interpretation and implementation of regulations, guidelines, company procedures, and policies. Develop and work with staff to implement quality process controls relating to all areas of operation, including the following systems: quality, facilities and equipment, materials management, production, packaging, and labeling.
- Prepare and conduct the Quality Management Review meetings with senior management.
- Manage GMP training initiatives
The Alexandria Group - 15 months ago