Susmitha Palakurthy
Quality Management System (Qms) Manager @Azurity Pharmaceuticals
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WORK HISTORY
Quality Management System (Qms) Manager @Azurity Pharmaceuticals
Lead and mentor the Quality Assurance Standards team responsible for quality systems to ensure compliance with SOPs and regulations. Manage Azurity Quality Standards team of 6 individuals responsible for document control, quality systems which include deviations, investigations, CAPAs, Change Controls, Annual Product Reviews, internal audit program. Review and approve Standards Operating Procedures, Specifications, Validation protocols and reports. Review and approve GMP records to ensure compliance with SOPs and regulations. Review and approve deviation investigations, CAPAs, Change Controls. Manage Change Control program for internal Azurity changes according to internal procedures. QA Support for implementation of Trackwise Digital for quality systems including deviation, CAPAs, Change Controls and Document Management System. Manage Internal Audit Program according to internal procedures. This includes publishing internal audit schedules, audit execution, report issuance and follow up to audit commitments. Support regulatory audits and a state of continuous inspection readiness. Manage, author and/or review Annual Product Reviews for internal and external products. Gather, track and report QMS metrics to Quality Management. Support cGMP Triages for Deviations, CAPAs and Complaints
EDUCATION
Campbell University
Masters, Pharmaceutical Sciences
Jawaharlal Nehru Technological University
Bachelor, Pharmacy
SKILLS
ABOUT SUSMITHA PALAKURTHY
Diligent professional possessing a master’s degree in Pharmaceutical Sciences combined with 16+ years of cGMP Quality experience in Pharmaceutical and Biotech industry. Background includes working in Quality Assurance Management, Quality Systems, Document Control, Quality Control, Regulatory Audits, Customer Complaints, Deviations, CAPAs, Change Controls, Root Cause Analysis, QA for Validation, Batch record review and lot disposition, Annual Product Reviews, Quality procedures. Worked under cGMP regulations in a high-volume, fast-paced environment, managed QA Compliance team, analytical QC Chemistry work experience and Quality oversight for QC Lab. Demonstrated outstanding team management & leadership abilities, extraordinary attention to detail, excellent organizational skills, and the ability to communicate effectively with management, peers, subordinates, and external vendors. Strong presentation skills, both oral and written. Excels independently, within a team and leading a team.SKILLS• Detail-oriented• Leadership, team management• Quality Assurance Operations & Standards • Document control• Change controls• Deviations• Out-of-specification investigations• Corrective and preventative actions • Product quality customer complaints• Knowledge in US cGMP Regulations and guidance• Batch Record reviews, Lot dispositions• Standard operating procedures• Internal, External Audits and experience in FDA Regulatory audits• Annual product reviews• TrackWise, SOLABS• Excellent communication skills• Decision making, planning and organizing • Proactively solving Quality issues while providing a safe and compliant process
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