Q

Validation Specialist

icon building Company : QRC Group
icon briefcase Job Type : Contract

Job Description - Validation Specialist

Validation Specialist with hands-on experience in executing validation and qualification activities across one or multiple areas, including:
  • Process
  • Packaging
  • Manufacturing
  • Laboratory
  • CSV
  • Software
  • Facilities and Utilities
  • Site Acceptance Testing (SAT) and Factory Acceptance Testing (FAT)
  • Commissioning and Decommissioning of Systems and Equipment

Core Strengths:

  • Skilled in drafting protocols, reports, and technical documentation aligned with regulatory standards
  • Proven ability to collaborate with cross-functional teams (Engineering, Quality, Production) to ensure compliance and operational efficiency


Requirements


  • Bachelor Degree in Science, or related field
  • Minimum 5 years of experience in validations within a regulated industry.
  • In-depth knowledge of GMP, FDA, and international standards.
  • Hands-on experience in IQ/OQ/PQ, SAT/FAT, and commissioning.
  • Ability to write clear and precise technical documentation.
  • Excellent communication and teamwork skills.
  • Bilingual (English/Spanish - understand, write and speak).




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