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[QUOTE=Guest;260543]B. N.M.MANOHAR [b][i][u]E-Mail [/u][/i][/b]: madhubalishetty AT gmail.com [b][i][u]OBJECTIVE [/u][/i][/b]: To work as a task oriented/Quality specialist in a highly regulated, ever-changing Pharmaceutical industry where in I can put all my acquired skills and abilities to the optimum use to bring out the best for the company and myself. [b][i][u]EDUCATIONAL QUALIFICATION [/u][/i][/b]: M.Sc Bio chemistry from National P.G. college, Nandyal in the year 2010-2011 with an average of 60%. B.Sc. Bio technology, Bio chemistry & Chemistry from Sri Ramakrishna Degree Autonomous college, Nandyal in the year 2006-2008 with an average of 60%. Intermediate from the Board of Intermediate Education, A.P. S.S.C from Board of Secondary Education, A.P [b][i][u]Computer Skills [/u][/i][/b]: Computer Applications – Experience with MS Office, Internet, C etc… [b][i][u]PROFESSIONAL EXPERIENCE [/u][/i][/b]: (1Y) Orem Access Bio. Inc., Hyderabad, [b][i][u]Designation [/u][/i][/b]: Executive-QA [b][i][u]AREA OF INTERST [/u][/i][/b]:Quality Assurance,Research and Developement [b][i][u]HIGHLIGHTS OF EXPERIENCE [/u][/i][/b]: - Exposure in all aspects of Pharma QA – Documentation - Exposure in all Raw material and Packing material inspections. - Exposure in maintenance of controlled samples and their records. [b][i][u]KEY RESPONSIBILITIES [/u][/i][/b]: [b][i][u]- Control of Documents [/u][/i][/b]: Control of all master documents and obsolete documents like 1. Standard Operating Procedure, Operating Instructions, Cleaning Procedure, Guidelines. 2. Packing Material, Intermediates, Finished Product, Stability Specification/ Test Procedure & General Test Procedures. 3. Validation Protocols and their Status. Site Master File, Validation Master File & Quality Manual. [b][i][u]- Distribution & Retrieval of Documents [/u][/i][/b]: 1. All the approved documents – user copies distribution as per the SOP and retrieval of obsolete documents promptly. 2. Maintaining Issue Records for all controlled documents. [b][i][u]- Issue, Retrieval & Archival of Documents [/u][/i][/b]: 1. Issue of Batch Manufacturing records, Batch Traceability Records, Batch Packing Records, Record of Analysis, Registers, Usage Log Books, etc..., retrieval of the same after execution and archive till their retention period as per SOP. 2. Archiving documents systematically for easy retrieval. [b][i][u]- Co-ordination to Change Controls [/u][/i][/b]: - Promptly following for implementing, documents revision, approval, training, effective & disposal of change controls. - Support for Incidents, Deviations, and Market complaints. - Good exposure in close the Customer/Market complaints. - Create the Complaint forms and investigation Report Records. - Review of SOPs, Guidelines, and Formats etc… - Preparation of all master lists and updating as on date. - Co-ordination to in plant and on the job trainings. - Good exposure in MS Word, Excel presentations. - Arranging documentation support to Internal and Regulatory Audits. [b][i][u]- Raw Material and Packing Material inspections [/u][/i][/b]: - Raw material and Packing Material tested as per the given supplier COA. - Good exposure in Online inspections of manufacturing products. - To given the COA’s and Test Reports and labels of finished products to concern departments. [b][i][u]- Maintain control samples and Records [/u][/i][/b]: - To maintain the control samples and control samples records as per related SOP. [b][i][u]DECLARATION [/u][/i][/b]: I here by declare that the information furnished above is true to best of my knowledge. [b][i][u]Place [/u][/i][/b]: Hyderabad [b][i][u]Date [/u][/i][/b]: 05.01.2013 (Manohar.B)[/QUOTE]
