QC Instrument Qualification & CSV Specialist

NO DEVIATION PTE. LTD.; Singapore; On-site; SGD 80,000 - 100,000; Full time

Job summary

A dynamic engineering consultancy firm based in Singapore is seeking a QC Equipment & System Qualification Specialist to ensure compliance of laboratory instruments and systems within GMP/GxP frameworks. The ideal candidate will have expertise in laboratory equipment qualification, including Mass Spectrometry and FTIR, along with strong skills in Computer System Validation. Join us to contribute to impactful projects in the pharmaceutical industry while enjoying a robust health benefits and professional growth opportunities.

Benefits

Generous Leave Policy

Comprehensive Health & Wellness Coverage

Professional Development Opportunities

Inclusive Culture

Qualifications

• B.Sc. or M.Sc. in Chemistry, Analytical Science, Pharmaceutical Science, or related field.
• Experience in laboratory equipment qualification, particularly Mass Spec and FTIR.
• Strong understanding of Computer System Validation and 21 CFR Part 11.
• Familiarity with GMP and GLP regulatory requirements.

Responsibilities

• Perform qualification for analytical instruments like Mass Spectrometry and FTIR.
• Ensure compliance with GMP, GLP, and regulatory guidelines.
• Develop and execute qualification protocols and validation reports.
• Collaborate with vendors for instrument commissioning and maintenance.
• Conduct Computer System Validation activities following GAMP 5 guidelines.

Skills

Laboratory equipment qualification

Computer System Validation

Good Manufacturing Practices

Excellent documentation skills

Communication skills

Troubleshooting skills

Education

Bachelor's or Master's degree in Chemistry or related field

Tools

Mass Spectrometry

FTIR

LIMS

Chromatography data systems

Job description

A dynamic engineering consultancy firm based in Singapore is seeking a QC Equipment & System Qualification Specialist to ensure compliance of laboratory instruments and systems within GMP/GxP frameworks. The ideal candidate will have expertise in laboratory equipment qualification, including Mass Spectrometry and FTIR, along with strong skills in Computer System Validation. Join us to contribute to impactful projects in the pharmaceutical industry while enjoying a robust health benefits and professional growth opportunities.