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Validation Specialist

2 months ago

Singapore TRITON AI PTE. LTD. Full time
Job Title: Validation Specialist

At Triton AI Pte. Ltd., we are seeking a highly skilled Validation Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the validation of our manufacturing processes and equipment.

Responsibilities:
  • Execute Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and temperature mapping activities.
  • Conduct and document temperature mapping studies to ensure accurate temperature control.
  • Maintain accurate records of validation activities and temperature mapping.
  • Identify and resolve issues related to validation and temperature control.
Requirements:
  • Bachelor's degree in Life Sciences, Biotechnology, Engineering, or a related field.
  • 2-3 years' experience in validation with a good understanding of validation methodologies, including IQ, OQ, PQ, and temperature mapping.
  • Proficiency in temperature mapping in K is mandatory.
  • Knowledge of GMP, GDP, and other relevant regulations.
  • Foundational understanding of ICH Q7, Q8, ICH Q9, ISO 14644, ANSI Z1.4, and other regulatory requirements is preferred.
  • Demonstrated ability to work as both a team player and independently.
What We Offer:

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.