Analytical System Validator

4 days ago

Singapore beBeeValidation Full time $90,000 - $120,000

Join us in shaping the future of pharmaceutical solutions.

We are seeking a skilled Validation Specialist to support key validation activities within the Quality Control (QC) Laboratory. This role involves both software upgrade validation and the decommissioning of legacy computerized systems in a Good Manufacturing Practices (GMP)-regulated laboratory environment.

Key Responsibilities
  • Plan and execute validation activities associated with the software upgrade of a laboratory analytical system.
  • Develop and review validation documentation including User Requirements Specification (URS), risk assessments, protocols (Installation Qualification (IQ)/Operational Qualification (OQ)/Performance Qualification (PQ)), and summary reports in alignment with current regulatory requirements.
  • Collaborate with QC and Information Technology (IT) teams to ensure accurate integration of system requirements and compliance with data integrity expectations.
  • Lead or support the decommissioning of computerized systems used within the QC lab.
Required Skills and Qualifications
  • Bachelor's Degree in Life Sciences, Engineering, Computer Science, or a related discipline.
  • Proven experience in validation of computerized systems in a GMP laboratory or manufacturing environment.
  • Strong understanding of Good Automated Manufacturing Practice (GAMP) 5, FDA 21 Code of Federal Regulations (CFR) Part 11, and Annex 11 requirements.
  • Experience in system decommissioning and data migration strategies.
  • Excellent documentation, organizational, and communication skills.
  • Ability to work independently and collaboratively with cross-functional teams.
Benefits
  • Comprehensive Health and Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
  • Professional Development Opportunities: Access continuous learning programs and resources for career growth within the organization.
  • Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.

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