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 setting, preferably sterile injectables.

📌 Quality Control Validation (Nalagarh)
🏢 Immacule Life Sciences
📍 Nalagarh