Consultant / Senior Consultant / Project Manager

Responsibilities: Provide consulting services in Digital Transformation in the Life Science Manufacturing domain in one or more of the following disciplines: Computerized System Validation CSVIT 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, EU Annex11, and regulatory standards Familiar with IT Standard e.g., ISO 27000, ITIL, COBIT, etc. Experience in Software 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. Provide supports to Manufacturing Automation, Manufacturing IT and/or implementation, patch/hotfix and/or SDLC management such as change/ issue/ incident/ release etc. Knowledge of ISO9001, GAMP5, ISA88, ISA95, and other relevant pharmaceutical standards 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