Job Description

Responsibilities:

• Perform risk-based commissioning, qualification and validation service for pharmaceutical and biopharmaceutical clients on one or more of the following areas:

• Process Equipment
• CIP / SIP
• Temperature Controlled Unit (TCU)
• Utilities (e.g., water, gas, steam)
• HVAC
• Develop URS, specifications, risk assessment, system impact assessments, protocols and reports that support the commissioning, qualification and validation requirements in the industry.
• Develop validation protocols using a science and risk -based approach that meets regulatory requirements and industry best practices.
• Review, analyse, interpret, and summarize system and process performance data of executed activities for report and presentation to management.
• 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.

• At least Bachelor\'s degree in technical discipline such as Engineering or Science. Graduates of related discipline may also apply.
• Possess 2 or more years of experience in several CQV disciplines such as CIP, SIP, TCU, utilities, HVAC, etc. in pharmaceutical and medical device industry preferably with advanced technical knowledge in one or more discipline.
• Foundational understanding of ICH Q7, Q8, ICH Q9, ISO 14644, ANSI Z1.4 and other regulatory requirements preferred.
• Experience with investigations into manufacturing / laboratory deviations and determination of product impact potential, root cause and corrective/preventive actions.
• Knowledge of Validation Lifecycle approach (URS, FAT/SAT, commissioning, I/O/PQ Protocols, etc), guidelines, international regulatory requirements and other industry best practices.
• Ability to communicate quality and risk-related concept to technical and non-technical audiences.
• Good organizational skill and ability to work independently.
• Possess good written and oral communication, presentation, and data analysis skills.
• 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.
• For candidates from QC background, prefer to have experience in one or more of the following areas:

• Good Aseptic technique.
• Qualification of Laboratory Information Management System (LIMS) and/or MODA-EM including an ability to troubleshoot the system.
• Designing and conducting test methods validation (sterility test, disinfectant test, etc.)

• Consulting roles with international healthcare clients in strategically relevant projects.
• Working in a professional consultancy environment together with a highly motivated team.
• Opportunity to take on leadership responsibilities 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.

NNIT