Job Description

CSV & Quality Consultant(Junior Consultant)Responsibilities:

• Perform risk-based commissioning, qualification and validation of computer / computerized systems and processes.
• Executed / 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.
• Be part of the team that designs, executes, and optimizes qualification / validation strategies for a variety of platforms and software solutions, and presentation to management.
• Be part of the team that investigate deviations, write investigation reports and create summary reports.
• Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.Professional Skills and Experience:
• At least Bachelor's degree in technical discipline such as Engineering or Science or with experience relevant to the . Graduates of related discipline may also apply.
• Fresh graduate with internship experience in pharmaceutical industry will be given preference.
• Preferably with familiarity to the best practice / standards / regulations in the pharmaceutical industry.
• Preferably with basic technical knowledge of at least one (1) software solution (PCS / DCS / SCADA / MES / LIMS)
• Preferably with basic knowledge of at least one (1) industrially used programming language (Visual Basic / C++ / C# / Javascript)
• Preferably with good knowledge of Validation Lifecycle approach (URS, FAT/SAT, commissioning, I/O/PQ Protocols, etc), guidelines, international regulatory requirements, and other industry best practices.Offering:
• Consulting 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 growing premier consulting organization.
• Structured training program and peer mentoring system to support competence and personal growth.