Accomplished, high-performing, and results-driven cGMP quality expert with 13 years of extensive experience across multiple functions within pharmaceutical organizations, specialized in OSD manufacturing. Proven ability to develop, implement, and maintain effective Quality Management and Compliance Systems. Committed to delivering high-quality and safe products to patients while ensuring regulatory compliance with integrity. Experienced in In-process quality checks, audit trail reviews, handling of Process non conformance and investigations related to manufacturing, Review of batch processing records at different stages of manufacturing processing Area and Equipment validation and ensuring preventive maintenance and calibration of process equipments and utilities. Results-driven Quality Assurance Executive with expertise in regulatory compliance, critical negotiations, and deviations management. Proven track record of enhancing production quality and driving successful quality control initiatives. Dynamic Quality Assurance professional with extensive experience in leading quality control procedures and conducting thorough audits. Recognized for exceptional problem-solving skills and ability to collaborate with cross-functional teams to ensure compliance and address quality issues effectively. Detail-oriented quality assurance leader with a robust background in implementing quality control measures and ensuring regulatory compliance. Known for strong people management skills and effective in conducting in-process checks to drive quality improvement initiatives. Highly experienced in senior executive roles with a focus on quality assurance. Strong background in developing and implementing robust quality control processes, enhancing product reliability, and maintaining compliance with industry standards. Demonstrated strengths include leadership, strategic planning, problem-solving skills, and ability to drive continuous improvement initiatives. Notable impact made by improving operational efficiency and minimizing errors in previous organizations.
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