Senior QA Validation Engineer

2 weeks ago


Singapore INTEGRIX SERVICES PTE. LTD. Full time
Roles & Responsibilities

Responsibilities:
  • Review of qualification documents such as URS, DQ, IQ, OQ and PQ protocol for automation systems and equipment in compliance with the cGMP and site SOPs.
  • Preparation and review of automation systems, process, and cleaning validation protocols and reports.
  • Perform Quality Risk Assessment to determine criticality of the proposed changes.
  • Provide QA oversight and/or review during the validation process.
  • Participate in deviation investigations related to validation & qualification.
  • Familiarity with cGMP and CSV in a biopharmaceutical manufacturing site.
Requirements:
  • Degree in an engineering or science discipline or equivalent.
  • Minimum 8 years' of relevant experience in biopharmaceutical manufacturing environment.
  • Customer-focused and excellent communication skills
Tell employers what skills you have

Excellent Communication Skills
Risk Assessment
GMP
Test Cases
Cleaning Validation
Wireless
Interpreting
Protocol
Customerfocused
Life Sciences
Manufacturing
Commissioning

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