Laboratory Equipment Qualification Expert

5 days ago

Singapore beBeequalification Full time $80,000 - $120,000

We are seeking a highly skilled professional to join our team as a Qualification Specialist. This role is crucial in ensuring that all laboratory equipment and computerized systems meet regulatory standards and function efficiently.

Job Description

The ideal candidate will have expertise in laboratory equipment qualification, including Mass Spectrometry (MS), Fourier Transform Infrared Spectroscopy (FTIR), and other analytical instruments. They will also have a strong understanding of Computer System Validation (CSV) in a regulated environment.

This position involves performing qualifications for Mass Spectrometry, FTIR, and other analytical instruments, ensuring compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and regulatory guidelines. The successful candidate will develop and execute qualification protocols, risk assessments, and validation reports.

They will collaborate with vendors and internal teams for instrument commissioning, calibration, and maintenance, conduct Computer System Validation (CSV) activities for laboratory instruments and software systems following GAMP 5 guidelines. Additionally, they will ensure compliance with 21 CFR Part 11 and data integrity principles.

Key Responsibilities
  • Perform Qualification for Mass Spectrometry, FTIR, and other analytical instruments.
  • Ensure compliance with GMP, GLP, and regulatory guidelines.
  • Develop and execute qualification protocols, risk assessments, and validation reports.
  • Collaborate with vendors and internal teams for instrument commissioning, calibration, and maintenance.
  • Conduct CSV activities for laboratory instruments and software systems following GAMP 5 guidelines.
  • Ensure compliance with 21 CFR Part 11 and data integrity principles.
Required Skills and Qualifications
  • Bachelors or masters degree in chemistry, Analytical Science, Pharmaceutical Science, Engineering, or a related field.
  • Experience in laboratory equipment qualification, specifically Mass Spec, FTIR, and other QC analytical instruments.
  • Strong knowledge of CSV, 21 CFR Part 11, Data Integrity, and GAMP 5 guidelines.
  • Familiarity with GMP, GLP, and regulatory requirements for pharmaceutical laboratories.
  • Hands-on experience with LIMS, chromatography data systems, and electronic documentation systems is a plus.
Benefits
  • Generous Leave Policy.
  • Comprehensive Health & Wellness Coverage: robust medical and dental coverage to support your health needs.
  • Professional Development Opportunities: continuous learning programs and resources for career growth within the company.
  • Inclusive Culture: work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.

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