Job Description

Senior/Consultant (Digital) Job Roles: Responsibilities: . Provide consulting services in Digital Transformation in the Life Science Manufacturing domain in one or more of the Senior/Consultant (Digital) 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 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 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.