Consultant / Senior Consultant /Process Project Manager
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Consultant / Senior Consultant /Process Project Manager
role at
NNIT
Consultant / Senior Consultant /Process Project Manager
1 day ago Be among the first 25 applicants
Join to apply for the
Consultant / Senior Consultant /Process Project Manager
role at
NNIT
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
Process Manufacturing and related business processes including Quality Operations and Supply Chain Operations
Develop risk assessment, system impact assessments, protocols and reports that support the 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
Singapore
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Details
Type of contract: Full time
Location(s): Singapore
Language(s): English
Mobility: N/A
Application Deadline: 31/12/2025
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
Process Manufacturing and related business processes including Quality Operations and Supply Chain Operations
Method validation (analytical chemistry, biochemistry, microbiological)
Enterprise system (LIMS, QMS)
Develop risk assessment, system impact assessments, protocols and reports that support the 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
Professional Skills And Experience
At least Bachelor's degree in technical discipline such as Engineering or Science or with experience relevant to the Job Description. Graduates of related discipline may also apply
3 or more years of experience in several functions in pharmaceutical industry: commissioning, qualification, validation, quality systems, quality operations, manufacturing, engineering, technology transfer
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
Preferred to have experiences in multiple CQV discipline (such as CIP, SIP, process, utility, equipment, automation, computer system, lab system), preferably with advanced technical knowledge in one or more discipline
Preferred to have experience interacting with or creating material for management and regulatory agencies
Ability to communicate quality and risk-related concept to technical and non-technical audiences
Good organizational skill and ability to work independently
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
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.)
Offering
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
About NNIT
NNIT is a publicly listed company that specializes in IT solutions to life sciences internationally, and to the public and enterprise sectors in Denmark. We focus on high complexity industries and thrive in environments where regulatory demands and complexity are high. We advise on and build sustainable digital solutions that work for the patients, citizens, employees, end users or customers. NNIT consists of group company NNIT A/S and subsidiaries SCALES, Excellis Health Solutions and SL Controls. Together, these companies employ more than 1,800 people in Europe, Asia, and USA.
We celebrate diversity and are committed to creating an inclusive environment for all employees. All candidates are encouraged to apply for the given job regardless of their gender, age, religious beliefs, sexual orientation, national and social origin, political opinion, disability, race, skin colour, and ethnic origin.
In the interest of fostering a fair and unbiased recruitment process, we kindly request candidates to refrain from including their pictures in their applications.
Learn more about working at NNIT
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Seniority level
Seniority level Mid-Senior level
Employment type
Employment type Full-time
Job function
Job function Consulting, Information Technology, and Sales
Industries IT Services and IT Consulting
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