Job description : Consultant   Firm : KPMG  Service line : ITA - Risk Consulting - CSV  Job level : Consultant  Specific skill set required : Computer System Validation / Software Tester in Pharma or Life Sciences domain/ 21 CFR Part 11  Graduation / Post Grad - BE/ B Tech/ MCA/MBA./M.S  Professional qualification : Experience in Life Sciences domain   Work experience : 3 - 4 years of total work experience with at least 2 years of experience in Life Sciences regulatory compliance and/or in life sciences / pharmaceutical / medical devices industry  The key job responsibilities include the following :  - Work on computer system validation life cycle on Life Sciences engagements  - Draft and review SDLC deliverables  - Work on Testing life cycle in life sciences regulated environment   - Demonstrate ability to analyze problems, develop solutions, and communicate results  - Work with Software testing tools HPQC, document management and change control tools  - Strong communication (both written and verbal English), and organizational and interpersonal relationship-building skills  - CSV experience in instruments / equipment's etc  - Good understanding and practical experience with FDA cGxP regulations: 21 CFR Part 11, EMEA, ICH Q9, 21 CFR Part 820,, PIC/S, ISO   - Travel across locations and regions  The key skills required are as follows :  - Industry sub segment experience (e.g., pharmaceutical, medical device, biotechnology) in the areas of manufacturing, supply chain, quality assurance/quality control or regulatory compliance   - Operational area (e.g., R&D/clinical, operations/manufacturing, quality assurance/control, IT, supply chain, commercial)   - Process knowledge and experience (e.g., ERP, drug safety/Pharmacovigilance, product life cycle management, Infrastructure qualification, manufacturing execution, quality systems, IT quality systems, records management)   - Functional or technical computer system knowledge and experience (e.g., EDMS, SAP, Oracle, LIMS, Documentum, MES, PLM)   - Specific quality business process knowledge and experience (e.g., adverse event reporting, change control, document management, CAPA, product testing, auditing, risk assessments)  Location : Hyderabad, Gurgaon, Bengaluru

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KPMG - Consultant - ITA - Risk Consulting - CSV 

KPMG - Consultant - ITA - Risk Consulting - CSV  ,Job Description for KPMG - Consultant - ITA - Risk Consulting - CSV  in KPMG in  Delhi NCR Bangalore Hyderabad Others for (3-4) years of experience. Apply Now!

Job Description for KPMG - Consultant - ITA - Risk Consulting - CSV  in KPMG in  Delhi NCR Bangalore Hyderabad Others for (3-4) years of experience. Apply Now!