Job Roles:

Responsibilities:

· 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 7 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

Offering:

· 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.