QC Validation Specialist

2 days ago


Singapur, Singapore NO DEVIATION PTE. LTD. Full time
QC Validation Specialist

No Deviation PTE. LTD. is a leading provider of patient-centric solutions for the pharmaceutical industry. We are seeking a highly skilled QC Validation Specialist to join our team.

Key Responsibilities:
  • Provide guidance and direction on commissioning/qualification activities to ensure compliance with regulatory standards.
  • Assist in change control assessments and reviews to maintain the integrity of our laboratory systems.
  • Conduct laboratory computer system data integrity assessments and reviews to ensure accuracy and reliability.
  • Lead the setup, configuration, and deployment of the LIMS system within the QC department to optimize workflows and efficiency.
  • Work closely with QC and IT teams to ensure that the LIMS meets all operational and regulatory requirements.
  • Customize LIMS workflows, forms, and reports to align with specific QC processes and improve data management.
  • Develop and execute qualification and validation protocols for the LIMS to ensure compliance with relevant regulations.
  • Perform system validation and testing to ensure the LIMS functions as intended and meets regulatory standards.
Requirements:
  • Bachelor's degree in a relevant field (Chemistry, Biochemistry, Engineering, or similar).
  • Minimum of 3-5 years of experience in QC within a regulated industry (e.g., pharmaceuticals, biotechnology).
  • Proven experience in LIMS implementation, configuration, and validation.
  • Strong understanding of qualification and validation processes in a GMP/GLP environment.
  • Proficiency in LIMS software (e.g., LabWare, STARLIMS, SampleManager) and laboratory automation.
  • Excellent project management and organizational skills.


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