Jobs

    Senior/Consultant (Manufacturing Science and Technology) - Singapur, Singapore - NNIT

    NNIT
    NNIT Singapur, Singapore

    2 weeks ago

    Default job background
    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 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.)
  • Fresh graduate is welcome to apply for junior position. Preference will be given to those with internship experience in the pharmaceutical industry.
  • 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.

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