Head of Information Technology

1 month ago


himachal pradesh, India Acme Generics Full time

Key Responsibilities

  • 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) which includes conceptualization, assessment, evaluation, implementation, validation, operation and retirement stages of computerized system. With effective project management and problem-solving skills.
  • Computer System Validations (CSV) with risk-based approach as per GAMP 5 guideline. 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 Scientific Applications (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 on EDC related regulatory guidelines and Industry best practices
  • Software Development & Implementations (Development of web/windows applications of various Bespoke) for process automations for better performance and effectiveness.
  • Thorough knowledge on CSV functions including validating enterprise applications like Empower, Chromeleon, SAP, LabWare LIMS, NuGenesis SDMS, Analyst, Eurotherm, DAS, SCADA, Microsoft Excel Worksheets etc., Assessments like Risk, GxP, ER/ES, Traceability etc., Equipment Qualifications, Network Qualification as per organization’s Validation Master Plan and respective Protocols and Procedures.
  • Able to work on own initiative and as part of a team. Proven leadership skills involving managing, developing and motivating teams to achieve their objectives and organization goals. 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 Pharma guidelines like GAMP 5, 21 CFR Part 11, EU Annex 11, WHO Annex 5, ISO 13485, GDPR, SOX, ITIL.
  • Thorough functional and technical knowledge various Pharma software systems and instruments like LabWare 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 validations.
  • Thorough knowledge of the various business processes involved in Pharmaceutical industry.
  • Witnessed various international audits like FDA, WHO, MHRA, TGA, ANVISA, EU-GMP, USFDA.
  • Good in software development (both web and windows with client-server based).



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