Alka Mishra

Experience

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  Cipla

  Jun 2005 - Dec 2009

  Review of Development strategy and ensure that the Development is done as per the strategy. Review of Product development report (Technical Report) as in line with ICH guidelines and developmental stages. To efficiently resolving the queries governed by regulatory related to new product .Review of Master manufacturing guide and technical analytical docket as in line with critical quality attributes decided during development of product.Review of Master BMR / Mater BPR and Process Validation Protocol / Report.Handling of the technology transfer activity during new product transfer from R&D to manufacturing location. Handling and review of QMS documents such as change control / Incident / Deviation/ investigation and CAPA.Handling of Software for Extrapolation of shelf life of product as per ICH Q1 E. Handling of Software for the T/R calculation of Nasal spray (calculation 90% confidence). Show less Responsibility for the audit of Store, Packing area in Manufacturing location . Managing work force independently with respect to work allocation of Packing QA Team, to ensure and Improvement of Quality, dispatch activity etc. To responsible for the in-process quality checks and line clearance inspection effectively.Handling of dispatch activity of finished product and Review of document for the clearance of dispatch such as BMR, BPR and ATR (Analytical Test Report)To coordinate with QC and production for the timely dispatch of the finished product.Handling of failure investigation, market complaint related to Packing /dispatch activity.Handling of document such as; Validation Protocol / Report.Active Lead member of QA team for qualification of Utility systems (such as water system, steam supplier, heat air supplier , HVAC) of new facility and implementation of Regulatory and Quality system. Show less

  • QA

    Mar 2007 - Dec 2009

  • QA

    Jun 2005 - Mar 2007
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  Ipca Laboratories Limited

  Dec 2009 - Jan 2023

  QA

  My Responsibilities include preparation of the Audit program and Audit Plan and conduct the Audit according to the Plan. To prepare the Observation Report and follow-up for the corrective action response.To Review the Audit compliance response and verification of the implementation of the Audit compliance response. To Review of Pharmaceutical product development Report and Analytical Method Validation Report as per the Analytical Method Validation Protocol and preparation of the Review report.Handling and review of QMS documents such as Change control / Incident / Deviation/ investigation and Corrective action.Reviewing the Qualification Protocol, General & Operation SOP, Annexure Format. Identification of training needs and imparting it to increasing the Quality / productivity efficiently. Show less

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  Tata Consultancy Services

  Dec 2022 - now

  Change Control Specialist