Qualification Engineer Role

3 days ago

Singapore beBeeQualification Full time $90,000 - $120,000
Job Title: QC Qualification Specialist

At our organization, we are committed to delivering innovative solutions that transform the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we seek individuals who share our passion for impactful projects and driving innovation.

We believe that outstanding results emerge when Empathy, Integrity, and Transparency guide our actions. To foster a culture of collaboration, inclusion, and continuous development, we empower our team members to grow personally and professionally.

Position Overview:

We are looking for a qualified professional with expertise in laboratory equipment qualification, including Mass Spectrometry (MS), Fourier Transform Infrared Spectroscopy (FTIR), and other analytical instruments.

The ideal candidate will possess a strong understanding of Computer System Validation (CSV) in a regulated environment and be able to ensure that all Quality Control (QC) instruments and computerized systems meet compliance standards and function efficiently within GMP/GxP frameworks.

Key Responsibilities:
  • Perform Qualification for Mass Spectrometry, FTIR, and other analytical instruments.
  • Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (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 Computer System Validation (CSV) activities for laboratory instruments and software systems following GAMP 5 guidelines.
  • Ensure compliance with 21 CFR Part 11 and data integrity principles.
  • Assist in software verification and validation (IQ, OQ, PQ) for laboratory data systems.
  • Work with IT and Quality teams to implement and maintain validated computerized systems.
  • Maintain accurate and complete documentation for all qualification and validation activities.
  • Conduct periodic reviews, requalification, and risk assessments of laboratory systems.
  • Support audits and regulatory inspections by providing necessary qualification and validation records.
  • Investigate deviations and implement corrective and preventive actions (CAPA) related to QC systems.
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 Computer System Validation (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.
  • Excellent documentation, communication, and troubleshooting skills.
  • Ability to work collaboratively with cross-functional teams, vendors, and regulatory bodies.
Benefits:
  • Generous Leave Policy.
  • Comprehensive Health & 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.
  • Shape the Future:
  • Make a real difference in the pharmaceutical industry while advancing your career.

Are you passionate about making an impact? We invite you to submit your resume, outlining your qualifications and experience relevant to the role.

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