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Computer System Validation (CSV) is part of the ITOT organization located in Singapore with primary focus on CSV strategy and validation activities for site ITOT products. Scope of CSV activities for ITOT product covers Local software instances qualification for Global/Core system such as MES, local vendor product software qualification, IT infrastructure (eg. server/workstation/network switches).
Work closely with site CSV Lead in on 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.
Safety, Health & Environment:
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.
Lean Production System:
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.
Who You Are
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.
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.