Computer System Validation

Key Responsibilities:

• Deliver consulting projects to support introduction, upgrade and maintenance of laboratory equipment with computerised system in the Life Sciences clients.
  
  
• Draft CQV and CSV deliverables such as URS, risk assessment, audit trail assessment, ERES assessment, IOPQ protocols, specifications and RTM.
  
  
• Execute CQ and CSV activities.
  
  
• Support equipment integration with other system such as network, manufacturing system and enterprise system.
  
  
• Support system configuration and CS activities such as backup and restore, access management, periodic review, etc.
  Draft, revise and review SOPs, forms and related operational and maintenance documents.
  
  

Requirements:

• Hold Bachelor's degree in Life Sciences, Engineering or related field.
  
  
• Have worked at least 2 years in pharmaceutical, medical device or related environment.
  
  
• Fresh graduates with internship in pharmaceutical or medical device industry and some relevant experience may apply for a Junior role.
  
  
• Have experience maintaining laboratory equipment with computerised system in pharmaceutical / medical device settings.
  
  
• Understand computerised system regulatory requirements (e.g., 21 CFR Part 11, Annex 11) and industry best practice (e.g., ISPE GAMP5).
  
  
• Preferably with experience in change, incident and problem management.
  
  
• Preferably with technical knowledge of Windows OS, security system and backup system.
  Preferably with experience in configuring systems like LIMS, LES or ELN.
  
  

Why Join Orka:

• Work that Matters: Support clients bringing innovative and life saving solutions to the population.
  
  
• Career Development: Build a consulting career in a professional consulting company with Life Sciences focus.
  
  
• Professional Environment: Work with similar professionals possessing Intelligent, Resourceful, Loyal and Teamwork characteristics.
  
  
• Impactful Learning and Mentoring: Develop yourself in an environment that heavily foster learning attitude and benefit from access to training materials, references, mentors and management with wide range of regulated industry experiences.