ILCM Calibration Reviewer

2 weeks ago

Hyderabad, Telangana, India Ritsa Pharma Pvt. Ltd Full time ₹ 15,00,000 - ₹ 25,00,000 per year

Key Responsibilities

  • Review and approve calibration protocols, procedures, reports, and summaries for instruments and measurement systems.
  • Ensure calibration activities adhere to internal standards, global policies, and regulatory requirements (e.g. GMP, GLP, ISO).
  • Perform technical checks of calibration data, uncertainty calculations, trend analyses, and statistical evaluations.
  • Assess calibration deviations, nonconformities, out-of-tolerance results, root cause analysis, and corrective / preventive actions (CAPAs).
  • Ensure documentation quality, including traceability, version control, change control, and review cycles.
  • Liaise with calibration engineers, metrologists, field service vendors, and internal stakeholders (QC, R&D, Manufacturing).
  • Ensure calibration systems and software (LIMS, CMMS, calibration management systems) are properly controlled, validated, and used.
  • Support audit readiness by preparing responses to internal audits, regulatory inspections, and providing technical justifications.
  • Contribute to calibration strategy and continuous improvement initiatives (e.g. reducing downtime, optimizing calibration frequencies, risk-based calibration).
  • Participate in cross-functional initiatives, project work, and calibration change control reviews.
  • Provide training and guidance on calibration best practices, review expectations, and quality systems.

Education & Experience

  • Bachelor's degree (or higher) in Engineering, Physics, Chemistry, Metrology, Instrumentation, or a related technical field.
  • 3–6 years of experience
    in calibration, instrument qualification, metrology, or related roles in a pharmaceutical, biotech, or regulated environment.
  • Prior experience as a reviewer or technical lead in a calibration or quality environment preferred.

Technical Knowledge & Skills

  • Strong understanding of metrology principles: uncertainty, tolerances, traceability, and calibration standards.
  • Familiarity with GxP, GMP, GLP, ISO, and other regulatory expectations regarding calibration and instrumentation.
  • Experience with calibration software/systems such as LIMS, CMMS, or other calibration databases.
  • Good understanding of statistical and analytical methods relevant to calibration data review.
  • Excellent documentation skills and attention to detail.

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