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Senior/Consultant (Digital) Job Roles



  • Provide consulting services in Digital Transformation in the Life Science Manufacturing domain in one or more of the following disciplines:
  • Computerized System Validation CSV
  • IT Infrastructure Network Qualifications
  • Laboratory Instruments/Equipment
  • Production/Manufacturing System
  • Engineering/Automation
  • Digital, SaaS platforms, Cloud system etc.
  • Manage SDLC (system design life cycle) including risk, deviation, change managements eg. conduct risk impact or functional assessment(s)
  • Ensure Good Documentation Practices, working with policy and procedural governances, assessments, plans, reports etc.
  • Manage, develop and execute FAT/SAT, qualification protocols and test scripts with relevant quality and/or industry best practices
  • Review, analyze, evaluate system functions and processes to deliver validation deliverables

Professional Skills and Experience:

  • Minimum 2 years with at least BSc in technical discipline eg. Engineering, Science, IT or with relevant experience to the job description
  • Experience in engineering automation such as DCS, OSI PI Historian, Mfg systems and services, would be viewed favorably
  • Ability to communicate quality and risk-related concept to technical and non-technical audiences
  • Good written and oral communication skills, presentation, and data analytics with center of excellence
  • Demonstrated ability to work as both a team player and independently
  • Good organizational skills and ability to follow assignments through to completion and meet timelines with commitment to task and attention to detail
  • Develop approach using science, or risk -based approach that meets with good interpretation to regulatory regulations

Candidates with any of the following experience will have a distinct advantage:

  • Foundational understanding of ICH Q7/Q9, 21CFRPart11, EUGMP Annex11, and regulatory standards
  • Familiar with IT Standard eg. ISO 27000, ITIL, IT Best practices, COBIT etc.
  • Experience in SW development/troubleshooting eg. C#, JavaScript, Visual Basic, operating systems, and databases (SQL), and reports/labels (Crystal Report) preferred.
  • Provide supports to Mfg Automation, Mfg-IT and/or implementation, patch/hotfix and/or SDLC management such as change/ issue/ incident/ release etc.
  • Knowledge of ISO9001:2015, GAMP4/5 standards ANSI/ISA-88/-95, 21CFR Part 11/210/211, ERES guidelines and relevant regulations standards preferably
  • Experience with health compliance eg. global regulatory authorities, guidelines, Industry Best practices ie. USFDA, MHRA, ANVISA, NMPA, ICH Q7/Q9, Guidelines such as ISA 88/95


  • Consultation roles for international healthcare clients in strategically relevant projects.
  • Work in a professional consultancy environment within a highly motivated team.
  • Opportunity to take on responsibility and to help shape our organization.
  • Excellent career development and growth opportunities in a premier consulting organization.
  • Structured training program and peer mentoring system towards competence and personal growth.

Department: 110A Telok Ayer Street, Singapore

Location: Singapore

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Østmarken 3A, 2860 Søborg

IT advisory, development and operations with a strong focus on life sciences, finance, the public sector and large enterprises with equally high demands on quality and security.

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