Job Description

Responsibilities:

• Provide Computerized System Validation (CSV) / Computerized System Assurance (CSA) consulting services for pharmaceutical and medical device Manufacturing company.
• Manage SDLC (system design life cycle) including risk, deviation and change managements (e.g., conduct risk impact or functional assessment(s))
• Ensure Good Documentation Practices, working with policy and procedural governances, assessments, plans, reports etc.
• Develop and execute FAT/SAT test scripts, qualification protocols and reports based on industry best practices and Client\'s / Solution Provider\'s documentation system.
• Review, analyze and evaluate system functions and processes to deliver validation deliverables.
• Develop approach using science- or risk -based approach that meets regulatory expectation.
• If a Senior member of the team, serve as Lead for CSV service in one or more of the following disciplines:

• Production/Manufacturing System (e.g., MES, DCS, Historian)
• Laboratory Instruments/Equipment/Enterprise system (e.g., LIMS, Empower)
• Engineering/Automation (e.g., BMS)
• Emerging technologies (e.g., SaaS platforms, Cloud system)

• At least Bachelor\'s degree in technical discipline such as Engineering, Science or IT. Graduates of related discipline may also apply.
• Possess 2 or more years of experience performing CSV activities.
• Experience in engineering / process automation such as DCS, Historian, MES and/or PLC 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
• Foundational understanding of ICH Q7/Q9, 21 CFR Part 11, EU Annex 11 and regulatory requirements.
• Experience in Software development / troubleshooting e.g., C#, JavaScript, Visual Basic, operating systems, databases (SQL) and reports/labels (Crystal Report) preferred.
• Experience in providing 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 / best practices.

• Consulting roles for pharmaceutical and medical device clients in strategically relevant projects.
• Work in a professional consultancy environment within a highly motivated team.
• Opportunity to develop skills and deliver projects in both technical and qualification / validation scope.
• 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.

NNIT