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Roche

Computer System Validation Internship

Roche
BiopharmaCentral SingaporeFull-time2 weeks ago
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About the role

AI summarised

This is an internship position in Computer System Validation (CSV) at Roche's ITOT organization in Singapore. The intern will support CSV activities for ITOT products, including generating deliverables, managing lifecycle documentation, and generating protocols for commissioning and qualification, while adhering to quality standards and safety requirements.

BiopharmaFull-timeGeneral

Key Responsibilities

  • Work closely with site CSV Lead in to generate CSV deliverables for product software, IT infrastructure (eg. server/workstation/network switches) during projects for systems that are maintained by ITOT team.
  • Work with local ITOT and cross functional teams (eg. Quality Validation, MSAT Automation, Manufacturing, Quality Control etc) for assessment such as System Impact Assessment, Critical Assessment, Data Integrity Assessment, Audit Trail Assessment etc.
  • Manage the maintenance of life cycle documentation.
  • Generate protocols for commissioning and qualification activities for ITOT products.
  • Adhere to the requirements specified in Automation and ITOT related Roche & quality policies/quality standards or related SOP.
  • Adopt Roche's good engineering practice documents as guidance documents when performing the work function.
  • Comply with all RSTO's Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.
  • Observe all RSTO's site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.
  • Embody PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives.

Requirements

  • Diploma or B.S in Computer Science, Chemical Engineering, Electrical Engineering or equivalent degree and relevant work experience/training.
  • Experience/familiar with IT/Automation system support in biotech/pharmaceutical manufacturing GMP environment is a plus.
  • Knowledge on CSV activities is a plus.
  • Candidates must be able to work well with others as a team member in an in a results-oriented work environment.
  • Self-driven. Must have good communication skills (both verbal and written), and be able to work collaboratively with colleagues.