Quality Control & Assurance

• To design an appropriate Quality Management System (QMS)
• To implement any corrective and prevention actions
• To review and approve all documents (e.g. Validation and Test Plans, Test Protocol and Validation Summary Reports…), Validation Master Plan.
• To review and provide approve Standard operating procedures.
• Quality service according to guidelines stipulated by regulatory bodies.
• Independent review of  DATA
• Comprehensive review of calibration procedures;
• Review of Laboratory Investigation Procedures for Deviation and Out of Specification handling meeting FDA regulations.
• Implementing Effective Internal audit program with effective CAPA system.
• Co-ordinating inspections and audits by regulatory bodies and customers
• Database audits
• Site qualification/audits
• Quality Systems audits