Job for B.Sc, M.Sc, M.Tech as Deputy Manager in Biocon - BANGALORE : "D"

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Requirement	Deputy Manager - HC/JC/3398/2013
Job Category	Quality Control
Location	Bangalore
Experience	8.00 to 12.00 years
Education	B.Sc, M.Sc, M.Tech
Skills	1. Adherence to cGMP and cGLP 2. Adherenece to product specifications. 3. Good communication skills
Industry Type	Biopharmaceuticals
Posted On	27-Sep-2013
Job Description	1.      Audits: internal auditor and auditee for customary/regulatory/internal audits. 2.      Corrective and preventive actions as and when applicable. 3.      Allocate work within the department. 1.      Raw materials/in-process/finished/stability samples inspection, review and approval. 2.      Production process control in co-ordination with production. 3.      Review of maintenance and calibration records of measuring and testing equipment belonging to the quality control laboratory in co-ordination with maintenance department. 4.      Authority to handle complaints related to quality of the product (Customer as well as regulatory bodies). 5.      Product traceability - Reserve Samples. 6.      Identification, recording, evaluation and disposition of all nonconforming products and out of specification reports. 7.      Review of analysis reports and quality control records. 8.      Review of bacterial endotoxin test analysis, reports and approval. 9.      Review of sterility test analysis, reports and approval. 10.  Identification of training needs and training of personnel in quality control. 11.  Implementation and adherence to laboratory safety. 12.  Process validation: review of protocol and report. 13.  Investigation of OOS results. 14.  Analytical Method Validations and method transfers: review of protocol and report. 15.  Analytical method development. 16.  Issue of log sheets/checklists/other documents of QC lab for recording entries. 17.  In process quality control checks during the process. 18.  Qualification, validation, calibration and maintenance of measuring and testing equipment belonging to the Quality control laboratory in coordination with Maintenance department. 19.  Budgeting for quality control department. 20. Review of standard operating procedures, instrument/equipment operating procedures, general analytical   methods, packing/raw material/in process/finished product specifications. 21.  Review of certificate of analysis. 22.  Ensuring effective implementation of EHS management system in the organization. To follow the established procedures and policies of the company pertaining to EHS and report on the performance to the management.