Designation: Computer system Validation Lead(CSV) Exp: 7-9 yrs Job Location: Bangalore Mode Of Hire: Permanent Job description: Expertise in validation of enterprisewide quality IT SYSYEMS using CSV(Computer system Validation) GAMP5 AND FDA guidelines must Strong background in FDA
Should have FDA approval in Chemical/Micro. Should be well versed with chemical and instrumental analysis involving spectroscopy, HPLC, GC etc. Should be familiar with SAP and/ LIMS systems. Should have good experience of handling National/ International inspections and audits. Should have good
with respects to ISO, CE , India FDA . Etc. Maintenance of Good House Keeping, Safety and Correct use of Micro lab equipments. Maintenance of microbiological testing material / culture stock and records. Support Sterilisation Validation with respect to Microbiological test Liasion with external laboratory
Supports the business in addressing and solving quality problems- Conduct internal audits & participate in corporate and FDA audits- Support process validation programs for new product development- Work with cross-functional/cross - cultural teams to develop regulatory guidelines and procedures-
position, Software Sales preferably. Industry knowledge of the Pharmaceutical, Biotechnology or Chemical. Knowledge of Software solutions like Chromatography Data Software, Data Management, Electronic Lab Notebook, Laboratory Information Management Systems etc. Knowledge on FDA 21 CFR Part 11, Computer
formulation Salary Range: 10-12 Lacs per annum Job Profile: · Experience in compilation, review and submission of CTD dossiers to foreign drug agencies in ROW markets as well as general laisoning with the local FDA. · Interacting with the R&D centre as well as respective manufacturing Please refer the given job description for detailed information
validation reports, training records, BPCR distribution records). The retention periods for these documents should be specified. To prepare written procedures describing the receipt, identification, quarantine, storage, handling, sampling, testing and approval or rejection of material. To establish To carryout S. W. O. T analysis of your department and lay down short term and long term objectives for improvement ...
experience in dFMEA, DFM, Basic GD&T, Tolerance Stack-up. Concept design and development. Knowledge of manufacturing process. Very good Knowledge of Engineering Change Process. Design Verification and Validation. Design and Risk Management documents. Knowledge of Microsoft Project, SharePoint etc ...
supporting Utility equipments, Preventive maintenance, maintain records of all up to date Engg. Drawings, Documentation, Qualifications, Validations, Site maintenance, Preventive maintenance & execution of its schedule, Calibrations, etc. build up systems & SOPs. 5. Responsible for monitoring production