Alapati Madhuri
Quality Officer at APC Ltd- Claim this Profile
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Topline Score
Bio
Credentials
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Internal QMS Audit (ISO 9001:2015)
Kelmac GroupJan, 2020- Nov, 2024
Experience
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APC
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Ireland
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Pharmaceutical Manufacturing
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200 - 300 Employee
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Quality Officer
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Oct 2019 - Present
Quality Management System •Develop, enhance and maintain the Quality Assurance program to meet best in class standards. •Enhance the regulatory understanding and capability of the team. •Ensure the organization meets its statutory obligations in all Quality areas and supports the fostering of a workplace that focuses on ‘right first time’. •Ensure all SOPs, forms, logs, protocols and summary reports are completed and reviewed against Quality standards. Issue laboratory notebooks and equipment logbooks as required. •Support the development and implementation of the QMS program across the organization. •Ensure that all quality SOPs and programs are adhered to and are regularly reviewed, updated and communicated. Prepare Quality compliance metrics as required. •Ensure that all CAPAs and deviations are documented, investigated and recommended improvements implemented. Audit Readiness & Continuous Improvement •Provide subject matter expertise to Technical Operations on various Quality related topics. •Support any external Quality audits with the co-ordination of audit activities and action plans. •Conduct internal quality audits e.g. walkthrough audits, system audits, report issuance, CAPA follow-up, and closure. Ensure that follow-up actions are completed. •Ensure compliance of Quality and use analytics to measure compliance across the organization. •Facilitates ‘as is’ mapping and root cause analysis. Use continuous improvement tools to instigate actions for improvements. Collaboration & Engagement •Provide Quality oversight for assigned projects within Technical operations. Actively participate in projects by attending meetings (internal and external). •Contribute to and participate in the After-Action Review (AAR) meetings. •Collaborate with HR and Training on LMS and training activities. •Participate in relevant forums e.g. QMS/SMS, training, equipment as required to improve awareness of Quality. Show less
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Granules India Limited
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India
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Pharmaceutical Manufacturing
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700 & Above Employee
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Formulation Scientist
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Nov 2017 - Jan 2019
• Assisted research and development manager is determining R&D strategies and plans. • Established project goals and priorities, by collaborating with both marketing and sales departments. • Researched, designed and evaluated materials, processes and equipment. • Planned, conducted and interpreted formulation and process development experiments for drugs. • Reviewed the documents related to clinical studies and their outcomes. • Monitored and participated in design and production of pharmaceutical products in the form of capsules, powders, and tablets. • Wrote and maintained master formulas, manufacturing records, test reports and related protocols. • Interpreted and followed FDA and other governmental regulations for product formulations. • Worked in the lab and gave directions to technicians in the lab in utilizing the appropriate equipment and facilities to achieve target goal. • Involved in all stages of product development, from initial to final approval by FDA to market the product. • The ultimate- goal was to develop a stable, pharmaceutically and bioequivalent product compared to the Innovator. • Led a team of associates, scientists, and support staff in performing extensive and complex research and development in support of creating new pharmaceuticals. • Actively liaised between such departments as Regulatory Affairs, Analytical Development, Stability, Technical Services, Planning, Change Control, Production, Specifications, Packaging, Purchasing, Quality Operation, Material Management, Process Improvement, and Pharmaceutical Services, Marketing, and Legal Services. Show less
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Education
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2011 - 2017
Vaagdevi College of Pharmacy, Ramnagar, Hanamkonda, Warangal
Doctor of Pharmacy - PharmD, Pharmacy -
2008 - 2010
CV Raman Junior College
BiPC, Biology, General -
2007 - 2008
Geetanjali Vidhyanikethan
SSC, General
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