Cell Therapy Solutions Expert

2 weeks ago

Singapore beBeeInfrastructure Full time

Our company is a contract research development and manufacturing organization that enables scientists to translate their work into commercially available products at affordable prices.

We utilize cells as a final product or derive products from cells which often we use cells as the factory to derive our target product.

We are pioneers in cell-based meat production, being first in the world to be certified for cultivated/cell-based meat to FSSC 22000 and by a competent food regulatory body.

We have full capabilities from Drug Substance and small-scale fill & finish for final Cell Therapy Product. The candidate will be a key member of the Systems and Infrastructure team.

Responsibilities include:

  • Managing user access controls and ensuring data integrity across GMP-related IT systems.
  • Drafting, reviewing and maintaining IT-related SOPs and policies in compliance with GMP and regulatory requirements.
  • Ensuring electronic data from GMP systems are securely backed up and retained in accordance with approved SOPs, policies, and data integrity principles.
  • Implementing and maintaining systems and services across all environments in accordance with Company standards and policies.
  • Reviewing or proposing remediation solutions to address vulnerabilities identified and ensuring timely implementation.
  • Managing software/system upgrades and patches.
  • Providing remote and onsite support to computer users.
  • Executing daily tasks including hardware maintenance, backup status check, support and optimized key functional areas such as network, server, data communication, telecommunications system and security.
  • Participating in infrastructure improvement activities.
  • Ensuring proper IT infrastructure policies, standards, procedures and risk controls are followed during issue resolution.
  • Tracking and responding to deviations, incidents, and CAPAs related to IT systems.
  • Collaborating with cross-functional teams (Quality, Manufacturing, R&D) to implement and maintain compliant IT solutions.

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