Junior Consultant
2 weeks ago
About Us Headquartered in Denmark, NNIT Singapore Pte Ltd is a rapidly expanding leader in life science consulting, delivering innovative solutions across Singapore and the broader Asian region since 2011. We provide comprehensive, end-to-end services tailored to life science clients, covering every aspect of the value chain—from laboratory environments and clinical operations to regulatory affairs, manufacturing, and supply chain management. Guided by our core values— Open & Honest , Conscience Driven , and Value Adding —our approach ensures that these principles are reflected in every interaction. With a dedicated team of 1,700 consultants across Europe, Asia, and the USA, we are committed to supporting our clients in bringing vital medicinal products to patients. Role Overview NNIT is seeking talents from the life sciences industry for a full-time, on-site role at our biopharma client locations in Singapore. As a Junior Consultant in CSV, you\'ll be part of the team that designs, executes, and optimizes qualification / validation strategies for a variety of platforms and software solutions. In this role, you will report to your Senior Consultants or Line Manager and work closely with key stakeholders on-site. Key Responsibilities Support risk-based commissioning, qualification and validation of computer / computerized systems and processes. Execute/ develop validation protocols using a risk-based approach that meets customer quality, regulatory requirements, and industry best practices. Develop design review, risk assessment, system impact assessments, traceability matrix, protocols and reports that support the qualification and validation of computer / computerized systems and software solutions. Perform quality review of all system lifecycle specifications and documents against customer global / local quality processes, regulatory requirements, and industry best practices. Control and manage all project and system lifecycle specifications and documentation according to quality processes. Essential Qualifications Bachelor's degree in technical discipline such as Engineering, Science or other relevant field. Familiarity with 21CFR Part 11 and GAMP 5 categories in the pharmaceutical industry . Good knowledge of Validation Lifecycle approach (URS, FAT/SAT, commissioning, I/O/PQ Protocols, etc), guidelines, international regulatory requirements, and other industry best practices. Valuable Experience Incident/Deviation Management: Investigate deviations, conduct root-cause analysis, author investigation and summary reports. Troubleshooting: Resolve complex technical issues while maintaining compliance with CSV practices. What We Offer Impactful Projects: Consulting roles with international healthcare clients on strategically significant projects. Professional Environment: Work within a motivated team in a professional consultancy setting. Career Development: Excellent opportunities for career advancement within a leading consulting firm. Training & Mentoring: Structured training programs and peer mentoring to support your professional growth. If you're ready to make a significant impact in the life sciences field and advance your career with a rapidly growing firm, we invite you to apply for this exciting opportunity. #J-18808-Ljbffr
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