Head of IT Operations

6 days ago

Delhi, Delhi, India Acme Generics Full time
Job Title: Head of Information Technology

Acme Generics is seeking a highly skilled and experienced Head of Information Technology to lead our IT operations and drive digital transformation across the organization.

Key Responsibilities:
  • Electronic Data Compliance (EDC): Ensure compliance with GxP regulations, including 21 CFR Part 11, EU Annex 11, GAMP 5, and ISO 13485, with a focus on data integrity and reliability controls.
  • Computerized System Life Cycle Management (CSLCM): Oversee the conceptualization, assessment, evaluation, implementation, validation, operation, and retirement of computerized systems, with effective project management and problem-solving skills.
  • Computer System Validations (CSV): Lead risk-based CSV efforts as per GAMP 5 guidelines, including lab and production systems, enterprise systems, Excel sheets, and network qualification.
  • Quality Management System (QMS): Manage change controls, incidents, investigations, RCA, CAPA, audits, and quality risk management functions.
  • IT Services and Digital Transformation: Implement enterprise-level IT solutions, data analysis using various tools and dashboards, and process automations.
  • Scientific Applications and Production Applications: Implement CDS, LIMS, LES, SDMS, lab standalone systems, instrument interfacing, MES, DAS, SCADA, IPQC, BMS, ASRS, WMS, and material handling systems.
  • Peer Training and Software Development: Provide training on EDC regulatory guidelines and industry best practices, and develop web/windows applications for process automations.

Requirements:

  • Thorough knowledge of CSV functions, including validating enterprise applications like Empower, Chromeleon, SAP, LabWare LIMS, NuGenesis SDMS, Analyst, Eurotherm, DAS, SCADA, and Microsoft Excel Worksheets.
  • Assessments like risk, GxP, ER/ES, traceability, equipment qualifications, and 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, with proven leadership skills, first-class analytical, design, and problem-solving skills, and dedication to maintaining high-quality standards.
  • Excellent computer skills and versatility to new tasks/skills quickly.
  • Good working knowledge of various Pharma guidelines like GAMP 5, 21 CFR Part 11, EU Annex 11, WHO Annex 5, ISO 13485, GDPR, SOX, and ITIL.

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