Quality Control Validation

Role & responsibilities

• Perform and coordinate analytical method validation, verification and transfer activities for sterile pharmaceutical products.
• Prepare and review Validation Protocols, Validation Reports and related analytical documentation.
• Develop, review and execute protocols for:
• Method Validation
• Method Verification
• Method Transfer
• Cleaning Validation QC analytical support
• Hold Time Studies
• Stability Studies
• Process/Media-related analytical testing, where applicable
• Perform analytical testing using HPLC, GC, UV-Visible, Dissolution, FTIR, pH meter, TOC and other laboratory instruments.
• Handle validation parameters such as specificity, accuracy, precision, linearity, range, robustness, LOD and LOQ, as applicable.
• Ensure compliance with ICH, WHO-GMP, US FDA and applicable regulatory requirements.
• Review analytical data, chromatograms, calculations, worksheets and laboratory records.
• Investigate OOS, OOT, deviations and atypical results related to validation/testing activities.
• Support instrument qualification/calibration and laboratory equipment validation activities.
• Coordinate with QA, Production, R&D, Engineering and Regulatory Affairs for validation activities.
• Ensure proper implementation of SOPs, specifications, STPs, pharma copoeial requirements and data-integrity practices.
• Participate in internal audits, customer audits and regulatory inspections and provide required documentation/evidence.
• Ensure compliance with ALCOA+ data integrity principles and good documentation practices.
• Review trends and prepare analytical/statistical evaluation of validation data.
• Maintain validation schedules, trackers and periodic review records.

Preferred candidate profile

3-8 years of relevant experience in QC/Analytical Validation within a pharmaceutical manufacturing environment, preferably sterile injectables.