Consultant / Senior Consultant /Process Project Manager

SingaporeApply nowDetailsType of contract: Full timeLocation(s): SingaporeLanguage(s): EnglishMobility: N/AApplication Deadline: 31/12/2025ResponsibilitiesPerform risk-based commissioning, qualification and validation service for pharmaceutical and biopharmaceutical clients on one or more of the following areas:Process EquipmentCIP / SIPProcess Manufacturing and related business processes including Quality Operations and Supply Chain OperationsMethod 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 industryDevelop validation protocols using a science and risk -based approach that meets regulatory requirements and industry best practicesReview, analyse, interpret, and summarize system and process performance data of executed activities for report and presentation to managementInvestigate deviations, write investigation reports and create summary reportsExercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutionsProfessional Skills And ExperienceAt 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 apply3 or more years of experience in several functions in pharmaceutical industry: commissioning, qualification, validation, quality systems, quality operations, manufacturing, engineering, technology transferFoundational understanding of ICH Q7, Q8, ICH Q9, ISO 14644, ANSI Z1.4 and other regulatory requirements preferredExperience with investigations into manufacturing / laboratory deviations and determination of product impact potential, root cause and corrective/preventive actionsKnowledge of Validation Lifecycle approach (URS, FAT/SAT, commissioning, I/O/PQ Protocols, etc), guidelines, international regulatory requirements and other industry best practicesPreferred 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 disciplinePreferred to have experience interacting with or creating material for management and regulatory agenciesAbility to communicate quality and risk-related concept to technical and non-technical audiencesGood organizational skill and ability to work independentlyGood written and oral communication skills, presentation, and data analytics with center of excellenceDemonstrated ability to work as both a team player and independentlyGood organizational skills and ability to follow assignments through to completion and meet timelines with commitment to task and attention to detailFor candidates from QC background, prefer to have experience in one or more of the following areas:Good Aseptic techniqueQualification of Laboratory Information Management System (LIMS) and/or MODA-EM including an ability to troubleshoot the systemDesigning and conducting test methods validation (sterility test, disinfectant test, etc.)OfferingConsulting roles with international healthcare clients in strategically relevant projectsWorking in a professional consultancy environment together with a highly motivated teamOpportunity to take on leadership responsibilities and to help shape our organizationExcellent career development and growth opportunities in a growing premier consulting organizationStructured training program and peer mentoring system to support competence and personal growthAbout NNITNNIT 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 NNITApply now and liberate your talent!