Senior/consultant (Manufacturing Science and - Singapore - NNIT

NNIT

Verified Company

Singapore

5 days ago

Posted by:

Wei Jie

beBee Recruiter

Description

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 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 riskrelated concept to technical and nontechnical 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
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/ISA88/95, 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.