Quality Assurance Specialist

Job Description

• Review and approve CCRs and manage SOP review and approval process
• Responsible for timely completion of the SOP reviews
• Setup and ensure timely completion of the employee trainings
• Be Trainings and Document control site representative and manage all the activities for these implemented programs
• Maintain client test methods and specification data bases
• Perform internal audits and follow ups for effectiveness.
• Maintain vendor evaluation program
• Coordinate with clients and legal for quality agreements, maintain the data base and records
• Participates in the regulatory and client audits.
• Work as a backup in some designated areas in the absence of QA management.
• Overlooks as a QA, the equipment qualification, calibration and maintenance program; overview the technical SOPs for completeness.
• Approve method / specifications assessment form if provided. Review all CCR / technical memo of methods / protocols and reports
• Work on special projects as assigned by the Management
• Be backup for QA Associate
• Be active back up for review and approval of all OOS and deviation investigations
• Review and approve stability protocols, reports and CCRs.
• Review and approve equipment related protocols, and reports

Qualifications