Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Petaling Jaya

Description

Position Summary
As an “IT Validation” you will provide Software Development Lifecycle oversight to a multicultural team supporting various regulated pharmaceutical applications. You are also responsible to support the project and business team to deliver systems in compliant manner and review software documentation according to local/EU and FDA guidance. You also assist team in the development and approval of computerized systems requirements in accordance with guidance and policy documents.
Years of relevant working experience
1  year experience in GxP and GAMP
Academic Requirement
Master’s degree or equivalent work experience
Key competencies
Quality mindset
Understanding the importance of processes in regulated environments
Teaching others
Openness
Key responsibilities
Validation Support for Roche Global System (with a support of the more experienced team members)
Review of software documentation according to SSV corporate SOP’s, EU and FDA guidance
Observation of governance processes, escalation areas for improvement and assistance in the implementation of IT solutions in regulated it environments.
Mandatory skills
Foundation experience  validation in projects and system maintenance in various areas
Experience in the quality maintenance and support of regulated applications
Foundation experience with maintenance and support of applications under global inspection agencies, CFR 21 FDA Part 11, Annex 11
Good in stakeholder management
Desire to learn
English skills good in speaking and writing

About the company

Roche is a Swiss global health-care company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange.

The company headquarters are located in Basel and the company has many pharmaceutical and diagnostic sites around the world – including: Tucson, AZ; Pleasanton, CA; Vacaville, California, Oceanside, California, Branchburg, NJ; Indianapolis, Indiana; Florence, South Carolina; and Ponce, Puerto Rico in the US; Welwyn Garden City and Burgess Hill in the UK; Clarecastle in Ireland; Mannheim and Penzberg in Germany; Mississauga and Laval in Canada; Shanghai in China; Mumbai & Hyderabad in India; São Paulo and Rio de Janeiro, Brazil; Segrate, Milan in Italy; Johannesburg in South Africa; Karachi, Islamabad and Lahore in Pakistan. There are 26 manufacturing sites worldwide.

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