•9 years of Quality assurance experience, in Healthcare industry and in variety of environments Bio-pharmaceutical and Medical devices.
•Expertise in Handling Regulatory Audits and inspections including Mock FDA Inspection and Handling USFDA,ANVISA Inspections.
•Experienced team leader, including hiring, mentoring, and performance appraisals.
•Extensive experience in production process controls, Design controls, Regulatory audits, Design transfers, supplier transfers, vendor evaluations and qualification.
•Experienced in facilitating transfer of New Products from R&D to manufacturing.
•Experienced in handling new facility development and existing facility modifications and improvements.
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