Dhanunjayrao Valluri
Lead -e Compliance @Sandoz
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WORK HISTORY
Lead -e Compliance @Sandoz
Hyderabad, IN
Review and/or approve the key validation documents for computerized systems with a business line, divisions, and business unit scope (e.g, Systems Inventory, Quality Plan/Validation Protocol, GxP Risk Assessment, Validation Report, and GxP relevant changes and deviations, and site Validation plans). Review and approval of global QMS elements. Review and approval of Global STDs- SOPs. Review and approval of D.I Plan. Ensure in implementation of global systems in compliance at the sites. Ensuring that computerized systems activities are being carried out within the framework of local regulations and by all applicable Quality Modules and with the local requirements defined in SOPs. Alignment and coordination with the quality team and the operational IT team Review plans and documents of global projects and application documents as required. Ensure quality and support follow-up of Computerized Systems-related audits and inspections. Responsible for ensuring that all instrument/equipment software is compliant with MHRA and 21 CFR Part 11 data integrity requirements Support of inspection preparation activities Lead and/or support Computerized Systems topic-related work streams. Active member of Audit Teams and addresses the Audit Observations raised during the self-inspection and other Audits. Review/Approve instrument qualification data as SME. Monitoring of external IT service provider for the following and Compliance with IT life cycle change management. Verifying gaps against 21 CFR part 11, EU annexure 11, and other regulatory guidance’s and compliance with global procedures.
EDUCATION
Barkatullah University, Bhopal
Master's degree, Biotechnology
ABOUT DHANUNJAYRAO VALLURI
COVER LETTER Dear Sir/ Madam, To brief myself, I Dhanunjay Rao. Valluri, I had a total of 16+ years of experience in quality assurance in the field of Pharma and Biopharmaceutical formulations. Currently Working as a Standing senior Manager in Sanofi –Hyderabad- India till Date. As key role player Quality management System essentials*Change Control -Deviations -CAPA-Ers for various levels Presentation, Audits & Compliance-Suppler qualifications In-process Quality assurance, Validation-process/UtilitiesComputer systeams, GXP applications, Supporting SAP Team for Variolous /Applications for Warehouse. Plant Mainatanice QC ex. With a positive attitude and empowerment skills as inbuilt, I always like to take initiative and new challenges and enjoy working with people from various cross functionals. Going forward, I am keen to get explored and expertise in the relevant field, with broad experience. I enclose my curriculum vitae to give you an overall idea of my experience so far, which includes my strengths and skills too. Hope my application will draw your attention and I will get an opportunity to meet you with all my testimonials. I am confident that, I can make a difference and bring potential value to the organization, by meeting its core mission and business needs. Key Skills Garnished experience by working in Regulatory Plant with exposure to different Regulatory audits viz. USFDA, MHRA, WHO, MCC, TGA, to mention a few. GAP assessment, Global Documents compliance, Site procedure always in line with current Regulatory guidelines of USFDA & EU Experienced in handling various QMS-activities-Change control, Deviation, Investigations, CAPA thereof. Audits and compliance Supplier qualification, preparation of vendor audit calendar, vendor quality assurance by supplier auditing, and control of sub-contractor. Validation and qualification of process, equipment & Utilities,Cleaning Validation, and Moist Heat Serialization & to ensure Quality ComputerizedSystem Validation 4.0 / Pharma 4.0 principles are embedded into their evolution. Review and influence the future of operational and quality systems (i.e. deviation and change management, batch management, validation, training, etc.)
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