Senior Manager - Cdmo It

Lambda CRO

Ahmedabad, India
On-site
Csv frameworks and policies
Gxp, gamp5, she compliance
Data integrity (di) requirements
Lead the planning and implementation of IT infrastructure and network for the process and analytical functions of CDMO

Job Summary

  • Lead the planning and implementation of IT infrastructure and network for the process and analytical functions of CDMO.
  • Develop, implement, and ensure consistent and documented compliance to required CSV frameworks, policies, and procedures in alignment with pharmaceutical industry regulations.
  • Responsible for preparation and review of documentation related to qualification of LIMS, ELN and any other digital platforms.

Matching Summary

Lead the planning and implementation of IT infrastructure and network for the process and analytical functions of CDMO.

Skills & Requirements

Must-have

  • CSV frameworks and policies
  • GxP, GAMP5, SHE compliance
  • Data Integrity (DI) requirements
  • SAP ERP, Document Management Systems
  • SCADA, PLCs, MES, LIMS systems
  • Computerized system validation
  • IT system administration and user management

Nice-to-have

  • Cross-functional collaboration
  • Strong communication skills
  • Innovative technology application
  • Commitment to quality

Key Requirements

  • 8 to 12 years of relevant work experience
  • Bachelor/Master’s in Computer Applications/Information Technology
  • Prior experience in Information Technology, CSV digital platforms
  • Work experience on digital compliance in Pharmaceutical / Bio-pharmaceutical

Work Rights

Not specified

Tailored Resume

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