Validation Consultant

2 weeks ago


Singapore Triton AI Pte Ltd Full time
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.

Requirements:

  • 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.
  • Minimum 3 years of experience in pharmaceutical industry
  • Experiences in 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.
  • Strong knowledge of Validation Lifecycle approach (URS, FAT/SAT, commissioning, I/O/PQ Protocols, etc), guidelines, international regulatory requirements and other industry best practices.

Benefits:

  • Up to $6000 with 2 months Variable Bonus, Permanent Position
  • West Singapore
  • Pharmaceutical Industry Experience is a MUST
  • Experiences in multiple CQV discipline (such as CIP, SIP)
Reg No. R Triton AI Pte Ltd License no. 21C0661
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