Shaikh Karim Mohammad

Experience

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  Encore Healthcare paithan Aurangabad

  Sept 2011 - Nov 2013

  Officer

  Microbiological water sampling. Media preparation. GPT. Water analysis. MLT of liquid oral solid dosage forms. PET. Autoclave operation and validations of Autoclave.

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  Wockhardt Ltd

  Nov 2013 - Jan 2016

  Senior Officer
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  Wockhardt Ltd.

  Jan 2016 - now

  Junior Executive

  Quality Assurance : Software Track Wise (EQMS), SABA (LMS), DMS(Document Management System), TMS, SAP, MS-CIT Handling of Change controls. Deviations Management. Incidence in microbiology laboratory.Review and commenting on change control and deviation initiated by Cross functional team.Preparation and review of protocols and SOPs. Participate in investigations using various investigation tools. Participation in regulatory audit response.Planning and fulfilling the requirement of Regulatory audits like USFDA, MHRA, ANVISA, HPRA,WHO, ,KENYA,UGANDA etc. Review of OOS during analysis, investigations.Resolution and establishing the Corrective and preventive action. Preparation and review of media fill protocol. Execution of media fill activity. Intervention management. Excursions investigation Phase I, Phase II EM. Area qualification of Sterile and non sterile facilities. Establishment of alert and Action levels for EM.Executing the qualification activity of Grade maintaining devices (LAF, BSC, DPB), Incubators, Steam sterilizer, air samplers, compressed air Samplers. As a Team leader for Environment monitoring section Planning and execution for Environmental Monitoring Programme Sampling and monitoring of sterile SVP,CRT PFS facilities and WHD LOSD non sterile facilities. Conducting training on SOP’s and Protocols. Training and qualification of newly appointed analysts. Sterility Close Canister, Open and Direct inoculation methods. Complete Sterility session organization and compilation of sterility documents.Water sampling of potable, purified, pure steam and water for injection. Microbial analysis of potable, purified, pure steam and water for injection as per USP, BP Ph.Eur, IP.Water system validation. Bioburden analysis of different In-process. Media preparation and maintenance of records.Operation of Autoclave.Autoclave validation. Compilation of all qualification reports and protocol, as part of GDP.Disinfectant Efficacy Testing. Show less