4 years pharmaceutical quality/compliance experience in North America, and over 7 years pharmaceutical-related experience in China• Deep understanding the way of thinking in North American• Experience in response to regulatory-body (FDA, etc.) audits• Proficient in ralph lauren polo shirts a variety of instruments and equipment calibration, analytical method validation Lacoste Polo Shirts and transfer requirements• Excellent communication, coordination ability.
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Participates in Internal Audit Program, which includes the annual self-inspection and an on-going compliance evaluation through on-floor presence and periodic Cheap Lacoste Polo Shirts checks of the quality systems, procedures and practices.• Participates in preparation and support during regulatory-body audits. Involved in drafting responses, maintaining files, tracking commitments, and reporting on status until deficiency items have been completely addressed.• Monitors chi hair straightener trends of CAPA (Corrective Action/Preventive Action), prepares chi flat iron reports and provides recommendations with respect to continual quality improvements.• Writes, updates and reviews Standard Operating Procedures. Reviews intra- and inter-departmental change control chi flat iron requests for impact on related documents/procedures, and provides recommendation and/or guidance to members of other departments during documentation revisions.• Perform vendor evaluations and generate reports on introduction or change of new process/key material.• Coordinates, investigates and documents Product Complaints and Returned Goods ensuring that appropriate corrective and preventative actions are recommended, followed through and closed.• Monitors internal quality and compliance program, identifies issues, recommends training needs and participates in development of effective training cGMP modules to meet company needs. Schedules and delivers training to personnel, conducts assessments of the effectiveness of training and ensures adequate training records are maintained.• Reviews and approves protocols and reports relating to the Qualification of Equipment, Systems (such as utilities/computer) & facilities (DQ, IQ, OQ, PQ).• Co-ordinates the process, cleaning and computer validation programs.• Manage stability program (sampling, tracking and analysis).
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