Junior Validation Engineer

2 weeks ago


Singapur, Singapore Amaris Consulting Full time
Job description

You will be responsible to ensure all equipment, systems, and processes used and quality control are validated to meet regulatory requirements and standards. Your role will be crucial to maintain product quality, safety, and compliance throughout the product lifecycle.

Key Responsibilities:

  • Equipment and System Validation: Develop and execute validation protocols (Installation Qualification - IQ, Operational Qualification - OQ, and Performance Qualification - PQ) for manufacturing equipment, laboratory instruments, and computer systems.

  • Process Validation: Design and execute process validation protocols. Monitor and analyze process data to ensure consistent product quality and compliance with specifications.

  • Documentation and Reporting: Maintain detailed records of validation activities, including protocols, reports, and change control documentation

Qualifications:

  • Bachelor's degree in engineering, pharmaceutical sciences, or a related field.
  • Strong knowledge of pharmaceutical regulations (e.g., FDA 21 CFR Part 11, EU Annex 11) and quality standards (GMP, GLP).
  • Experience in validation within the pharmaceutical industry.
  • Proficiency in validation tools, equipment, and techniques.
  • Excellent project management skills and attention to detail.
  • Effective communication and teamwork skills.
  • Familiarity with risk assessment methodologies (e.g., FMEA).
  • Knowledge of statistical analysis and data trending.


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