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Manager - IT-CSV (Pharma)

10.00 to 20.00 Years   Noida, Chennai, Hyderabad, Gurugram   09 Jun, 2022
WHITESLIPS GLOBAL SERVICES PRIVATE LIMITED
Job LocationNoida, Chennai, Hyderabad, Gurugram
EducationNot Mentioned
SalaryRs 24 - 36 Lakh/Yr
IndustryPharma / Biotech
Functional AreaCustomer Service (Domestic)Operations Management / Process Analysis
EmploymentTypeFull-time

Job Description

    Electronic Data Compliance (EDC)of GxP (GMP, GLP, and GCP) systems with respect to 21 CFR Part 11, EU Annex 11, GAMP 5, WHO Annex 5, ISO 13485 guidelines with exposure on Data Integrity and Reliability controls and risk-based approach.Computerized System Life Cycle Management (CSLCM)includes the conceptualization, assessment, evaluation, implementation, validation, operation, and retirement stages of a computerized system. With effective project management and problem-solving skills.Computer System Validations (CSV)with the risk-based approach as per GAMP 5 guidelines. CSV include Lab & Production systems, Enterprise systems, Excel Sheets, Network Qualification etc.,Quality Management System (QMS)for Change controls, Incidents, Investigations, RCA, CAPA, Audits, Quality Risk Management etc., functions.IT Services, Digital Transformation, Process Automations & Data Analytics(application/technology implementation/management, implementation of enterprise-level IT solutions, and data analysis using various tools and dashboards)Implementation of scientificApplications(like CDS, LIMS, LES, SDMS, Lab Standalone Systems, Instrument interfacing etc.,)Production Applications(like MES, DAS, SCADA, IPQC, BMS, ASRS, WMS, Material Handling System, Track & Trace Serialization System etc.,)Peer Training onEDC related regulatory guidelines and industry best practicesSoftware Development & Implementations(Development of web/windows applications of various Bespoke) for processautomation forbetter performance and effectiveness.Thorough knowledge on CSV functions includingvalidatingenterprise applications like Empower, Chromeleon, SAP, LabWare LIMS, NuGenesis SDMS, Analyst, Eurotherm, DAS, SCADA, Microsoft Excel Worksheets etc.,Assessmentslike Risk, GxP, ER/ES, Traceability etc.,Equipment Qualifications, Network Qualificationsper organizations Validation Master Plan and respective Protocols and Procedures.Able to work on owninitiative andas part of a team. Proven leadership skills involving managing, developing and motivating teams to achieve their objectives and organizationalgoals. First-class analytical, design and problem-solving skills. Dedicated to maintaining high-quality standards. Excellent computer skills. Versatile to new tasks/skills quickly.Good working knowledge on various pharmaguidelines likeGAMP 5, 21 CFR Part 11, EU Annex 11, WHO Annex 5, ISO13485, GDPR, SOX, ITIL.Thorough functional and technicalknowledge of various Pharma software systems and instruments likeLabWare LIMS, Waters Empower CDS, NuGenesis SDMS, LES, Chromeleon CDS, Lab Solutions, Software for Clinical Studies, Data loggers, EMS, MES, PLC, HMI, DAS, SCADA, Firmware and other Pharma Industry related software with deployment, configuration, customization, user training, writing and executing the validationsThorough knowledge of the various business processes involved in the pharmaceuticalindustry.Witnessed various internationalaudits likeFDA, WHO, MHRA, TGA, ANVISA, EU-GMP, and USFDA.

Keyskills :
quality managementprocess automationsoftware developmentpharma

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