Experience

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  Foxx Life Sciences

  • Bengaluru, Karnataka, India

  • Quality Assurance Manager-Global operations

    • Sep 2022 - Present
    • Bengaluru, Karnataka, India

    i. Leading the organisational onsite requirements for the quality management systems as per ISO 13485, ISO 9001,21 CFR, ISO 20417,ICH and ISO 14971 and ensuring all statutory regulatory requirements are complying for new products.ii. Ensuring Design quality,Qualifications(IQ/OQ/PQ)and ISO 13485 & CE certifications requirements about medical devices.iii. Ensuring the changes implemented in the License, specifications, testing methods,and procedures etc.iv. Co ordinating with other cross functional departments for data collection and compilation for regulatory approvals.v.Direct manufacturing process development to meet or exceed the company's quality metrics and process metrics for current business and new business,vi.Communicate and coordinate with management,administrative, operations, quality and engineering departments,vii.conduct suppliers audits and internal audits.

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  Biocon

  • BANGALORE

  • Associate Manager

    • Jul 2015 - Sep 2022
    • BANGALORE

    Quality Management Systems: i. Responsible for reviewing and approving of quality management system procedures like Site Master File, Quality manual, Organogram, Validation master plan, Deviations, change controls, APQR’s, SOP’s, Protocols and reports (Qualification and Validations) and Quality agreements and CAPA reports routed through Documentation system. ii. To ensure, processes needed quality management systems are established, implemented and maintained for new products.iii. Responsible for reviewing and approving of Qualification documents / Contract testing lab agreements / service provider documents and to ensure updation of documents periodically.iv. Identifying training needs of team members and conducting training programs for the team as per regulatory requirements.v. Reviewing of Risk assessment protocols and Reports and ensuring documents are complying as per current regulatory requirements.Audit management: i. Performing Internal audits and, follow-up on the response, until ensuring satisfactory response and CAPA implementation from auditee end.ii. Also ensure CAPA response provided by CFTs and vendors is adequate and implemented and ensuring closure as per requirements.iii. Conducting the Internal audits for cross functional departments as per schedule, and ensuring satisfactory closure of Audit reports.Supplier Quality Management: i. Manage centralized vendor qualification and Audit activity. Responsible for Vendor qualification for all materials supplied to Biocon Ltd. ii. Review and Monitor the Qualification documents / credential of KSM, excipient and packing material vendors and also to complete Successful Qualification report. iii. Periodic updation of Qualification documents to maintain the Compliance. iv. Responsible for Review the proposal for alternate vendor source documents and evaluate the feasibility and qualification documents of proposed vendors.

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  Himalaya Herbal Healthcare

  • Bengaluru Area, India

  • sr.executive

    • Sep 2011 - Jul 2015
    • Bengaluru Area, India

    Reviewing of Analytical test data sheets (FP, SFG, RM), ensuring all analytical data as per Specifications, checking data integrity and releasing in LIMS (Laboratory information Management system).• Preparation of all laboratory documents as per regulatory requirements, and Compliance with, cGMP, cGLP, ISO guidelines, FDA and other regulatory bodies. Follow up with user Departments for in time closing of change controls and documents.• Practical understanding and experience resolving analytical testing deviations like OOS, OOT, CCF’s, and Incidents etc.• Root cause investigations of failures and implementing effective CAPA’s and giving training to Analysts.• Preparation of Method validation protocols, method validation reports and stability reports.• Responsible for issuance, storage, retrieval & destruction of Master and Controlled documents as per retention period.• Preparation of Qualification, calibration and validation reports.

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  Dr. Reddy's Laboratories

  • Hyderabad Area, India

  • Junior Manager

    • Jan 2009 - Jan 2011
    • Hyderabad Area, India

    ANALYTICAL: • Calibrations of HPLC, GC, FTIR, UV- Visible Spectrophotometer, Auto Titrator and other instruments and Preparation of SOP’s.• Maintenance of lab instruments and trouble shooting in analysis.• Analysis of RM, FP, IP and reaction intermediates by HPLC.• API analysis. Related substances, assay, Residual solvents and other tests.• Analytical method Development for new projects• Analytical method validations and analytical method transfer to Quality control.• Maintain the Laboratory as per cGLP. MICROBIOLOGY: • Media preparation. Culture maintenance, Preparation of Culture Suspensions and performing of GPT for regular Media.• Environmental Monitoring by Settle Plate Method, Volumetric Air Sampling, Surface Swab Method & Personal monitoring.• Microbial limit Test of Raw Materials and Finished products.• Identification of Environmental & Water isolates and lab cultures up to Species Level.• Handling Microbiology OOS, OOT’S, and CCF’S and finding root causes.• Maintenance of personal hygiene.• Preparing documents for the above listed microbiological operations and maintenance of all Microbiology records.

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  Vimala scientific services Pvt Ltd

  • Secunderābād, Telangana, India

  • Sr.Analyst

    • Jun 2006 - Jan 2009
    • Secunderābād, Telangana, India

    Distribution of samples and monitoring analysis basing on priority.• Maintenance of lab instruments and trouble shooting in analysis.• Preparation of standardization of volumetric solutions.• Preparation of standard operating procedures and calibration records.• Training of junior chemists on method of analysis.• Preservation of control samples and record maintenance.• Calibrations of HPLC, FTIR, UV- Visible Spectrophotometer and other instruments.