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Post : Solution Advisor - CSV
Job Description:
· Demonstrateability to analyze problems, develop solutions, and communicate results
· Complexproblem-solving abilities across operational, organizational, and strategicmatters
· Strongcommunication (both written and verbal English), and organizational andinterpersonal relationship-building skills
· Firmunderstanding and practical experience with FDA cGxP regulations and some ofthe following: EMEA, HC, ICH, 21 CFR Part 820, 21 CFR Part 11, PIC/S, ISO,MHLW, MHRA, PDMA, and 510(k) Submission Process
KeySkills:
· Industrysub segment experience (e.g., pharmaceutical, medical device, biotechnology) inthe areas of manufacturing, quality assurance/quality control or regulatorycompliance ·Operational area (e.g., R&D/clinical, operations/manufacturing, qualityassurance/control, IT, supply chain, commercial)
· Processknowledge and experience (e.g., drug safety/pharmacovigilance, product lifecycle management, computerized system validation, manufacturing execution,quality systems, IT quality systems, aggregate spend, records management)
·Functional or technical computer system knowledge and experience (e.g., EDMS,EQMS, SAP, Oracle, LIMS, Documentum,MES, PLM)
· Specificquality business process knowledge and experience (e.g., adverse eventreporting, change control, document management, CAPA, product testing, GMOauditing, risk assessments)
Additional Information:
Experience : BE, B.Tech, MCA, M.Tech./M.S.
Qualification :4-6 years
Location : Bangalore/Hyderabad
Industry Type : Pharma / Biotech / Clinical Research
Functional Area :ServiceLine/Market Offering: Regulatory and Compliance ‑ Healthcare
Last date : 30th August, 2016
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