Quality Assurance Analyst

Sekhmet Pharmaventures; Choutuppal; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Sekhmet Pharmaventures is seeking an Analytical Quality Assurance professional to review analytical data, chromatograms, spectra, and lab reports, ensuring data integrity across systems such as Empower, OpenLab, and LIMS.

The role requires verifying GDP/ALCOA+ adherence, reviewing method execution, and supporting investigations into OOS, OOT, incidents, and deviations to ensure complete, traceable records.

Responsibilities

• Review raw data, worksheets, chromatograms, spectra, calculations, and analytical reports.
• Review soft copy data in Empower, OpenLab, Lab Solutions, LIMS, CDS, and other systems.
• Examine electronic audit trails for data integrity and regulatory compliance.
• Verify adherence to ALCOA+ principles and Good Documentation Practices (GDP).
• Review analytical method execution for compliance with procedures.
• Support laboratory investigations; ensure analytical records are complete, accurate, and traceable.
• Coordinate investigations related to OOS, OOT, laboratory incidents, and deviations.

Job description

Role & responsibilities

Analytical Quality Assurance (AQA)

• Perform analytical data review of raw data, worksheets, chromatograms, spectra, calculations, and analytical reports.
• Conduct soft copy data review in laboratory software systems such as Empower, OpenLab, Lab Solutions, LIMS, CDS, etc.
• Review electronic audit trails for compliance with data integrity and regulatory requirements.
• Verify adherence to ALCOA+ principles and Good Documentation Practices (GDP).
• Review analytical method execution and ensure compliance with approved procedures.
• Support laboratory investigations and ensure analytical records are complete, accurate, and traceable.
• Perform and coordinate investigations related to:
  • Out of Specification (OOS)
  • Out of Trend (OOT)
  • Laboratory incidents
  • Deviations