Job Description

Brief Role : Regulatory Analyst - Information Technology Role: To act as Business process improvement manager, meet functional heads to understand relevant processes, and collaborate to design/ implement their IT needs with the help of in- house IT team and consultants Responsibilities: To prepare SOPs, policies, reviews in- line with current regulatory environment and maintain them periodically To ensure and conduct training activities (both internal & external) to upgrade staffs technical competency on the new and existing software solutions, IT SOPs etc. To prioritise multi- tasks effectively; taking into account factors such as project scope, deadlines, and urgency of need, and to ensure desired business results To act as a liaison with the vendor for finalising project requirements, defining project timelines and ensuring/ establishing SLA\'s to meet all internal expectations To align organisational reporting needs& goals with help of IT anddata analysis skills and systems To assist in management audits (internal & external) including audits ofUS- FDA, EU, MHRA, ANVISA, MCA, TGA, WHO, etc. To coordinate with site QA team, manage preparation of validation activities, and review of documents like validation plan, specifications (user requirements, functional, design, etc.), risk assessment, test plan &script, traceability matrix, validation summary report, user training manual & others for software and equipment To ensure compliance for computer system validation requirements, policies &procedures in line with the applicable regulatory requirements (GAMP5, 21CFR Part 11, EU Annex 11) To provide written and verbal communication including status reports, progress reports, and documentation to management & business partners.Salary:INR 5, 00, 000 - 15, 00, 000 P.A Industry:Pharma / Biotech / Clinical Research Functional Area:Analytics & Business Intelligence Role Category:Analytics & BI Role:Business Analyst Desired Candidate Profile Experience in : Project implementation: IT CGMP and Regulatory Affairs Periodic compliance evaluation of IT systems, to maintain the validated state: user access reviews and system configuration reviews Computer System Validation (FDA - 21 CFR Part 11, EMEA, etc.), QMS i.e. change controls, deviations, investigations, risk assessment/ FMEA, etc. SDLC and STLC: specialised in developing validation test strategies & plans IT governance & risk management in view of GxP, SoX compliance, IT projects delivery aligned with GAMP5 methodology to ensure compliance to pharmaceutical regulatory requirements IT service delivery for various GxP critical applications Exposure of International laboratory establishment inregulate environment USA/ EU Handling CCN, OOT, OOS, LER, deviation etc. 21 CFR Part 11 compliance and EU annexure XI requirements for Waters, Dionex, Shimadzu and Agilent softwares (electronic signature and auto calculation) Educational Qualification: Preferred Certifications: Short term courses regarding ITIL/ ITSM/ compliances & regulations, etc. Personal Attributes: Good communication skills, pleasant personality, team management capabilities, managing multiple responsibilities and partnering with different stakeholders. Education- UG: B.Tech/ B.E. - Computers, Electronics/ Telecommunication, B.Pharma - Pharmacy, B.Sc - Any Specialization, Computers PG:M.Tech - Any Specialization, Computers, Electronics/ Telecommunication, M.Pharma - Pharmacy

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