Ann Saira Email & Phone Number

Ann Saira is a Bhat Biotech (P) Ltd at Bhat Biotech (P) Ltd.com. She possess expertise in clinical research, quality auditing, molecular cloning.

Listed skills include Clinical Research, Quality Auditing, and Molecular Cloning.

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  Engineer

  Bhat Biotech (P) Ltd.Com

  Aug 2011 - Present - Bangalore

   Analysis of Active and non active Raw Materials, Intermediates and in process testing & Finished products as per ISO 13485:2003 Stability and Self life testing & control sample activity and periodical sample analysis as per GLP Maintaining and cross checking the documents, assemblies, products and components and services related to production & management and conducting product inspection processes for Total Quality Management Handling Customer complaints & Product return and trouble shooting for defectiveness Sending the samples and equipments to the external laboratory and cross checking and maintaining the certificates Batch release of materials and maintaining production and release related reports  Creation and update of SOPs, validation protocols, validation reports and method validation/verifications and equipment qualifications Validation and Calibration of pipettes ,oven, Incubator ,Refrigerator and other equipments used in the production process Ensure compliance with current Good Manufacturing Procedures (cGMP) and other regulatory requirements at all times Prepare data summaries for inclusion in monthly reports, protocol, summary, document change requests and investigational reports. Participate directly in regulatory ISO and customer inspections/audits Perform other duties as assigned.