Job description : Senior Consultant / Assistant Manager  Firm : KPMG  Service line : ITA - Risk Consulting- CSV  Job level : Senior Consultant / Assistant Manager   Specific skill set required : Experience in Life Sciences Industry, functional knowledge of Pharmaceuticals, Biologics, Medical Devices & Diagnostics and FDA regulations, knowledge of analytics and reporting tools, 21 CFR part 11, 210, 211 Part 820, ICH Q9, QSR's, ISO 13485, GAMP, SDLC methodologies   Graduation / Post Graduate - BE/ B Tech, MCA/MBA./M.S   Professional qualification : Experience in Life Sciences / Pharma regulatory domain  Work experience : 4 - 7 years of total work experience with at least 4 -6 years experience in Life Sciences regulatory compliance and/or in life sciences / pharmaceutical / medical devices industry  The key job responsibilities include the following :  - Ensures documentation and practices meet quality standards, applicable regulatory compliance and company guidelines/policies  - Review functional or technical requirement documents and develop test cases to the stated requirements including positive and negative testing  - Review the accuracy and completeness of software validation deliverables created by other process teams (e.g., Requirements, IQ, OQ, UAT, Data Migration, SOPs, and Work Instructions)  - Create Traceability Matrices linking approved requirements to test cases in HPQC (both automated and manual)  - CSV experience in instruments / equipment's etc  - Works with fellow validation and project team members in a dynamic environment with shuffling priorities and responsibilities  - Provide expertise in the review of all deliverables across the project lifecycle, ranging from requirements documentation to final protocol reports  - Accurately report the status of assigned deliverables and support other compliance work as necessary  - Play a lead role in project management planning, economics, and billing  - Play a lead role in internal and external communication/deliverable quality including technical content of reports, proposals etc  - Travel across locations and regions  The key skills required are as follows :  - At least 5 years of computer system validation in a pharmaceutical/medical devices environment  - Experience in the validation of software and tools in a FDA regulated environment.(e.g,, ERP, Solution Manager, Document Management, CAPA and HPQC.) and Infrastructure Qualification  - Good knowledge of regulations and software lifecycle approaches (e.g., 21 CFR part 11, 210, 211 Part 820, ICH Q9, QSR's, ISO 13485, GAMP, SDLC methodologies)  - Ability to understand and write business processes as well as technical requirements  - Experience in development of Validation Master Plans for systems or facilities.  - Experience in Project execution within at least one area of systems validation - e.g., laboratory equipment, facilities, utilities, manufacturing equipment, information systems etc.  - Experience with MS Office applications including: Word, Excel, PowerPoint  - Strong communication skills, proficiency in MS Office suite  Other details :  Work timing : 9:30 a.m. to 6:00 p.m.  Location : Hyderabad, Gurgaon, Bengaluru  Preferred Companies to hire from : Sunpharma, Novartis, Dr Reddy, Philips healthcare

Delhi NCR

Bangalore

Hyderabad

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KPMG - Senior Consultant/Assistant Manager - ITA - Risk Consulting - CSV 

KPMG - Senior Consultant/Assistant Manager - ITA - Risk Consulting - CSV  ,Job Description for KPMG - Senior Consultant/Assistant Manager - ITA - Risk Consulting - CSV  in KPMG in  Delhi NCR Bangalore Hyderabad Others for (5-7) years of experience. Apply Now!

Job Description for KPMG - Senior Consultant/Assistant Manager - ITA - Risk Consulting - CSV  in KPMG in  Delhi NCR Bangalore Hyderabad Others for (5-7) years of experience. Apply Now!