QC - ADL

Key Responsibilities

1. Perform analytical method development, optimization, verification and validation for APIs, intermediates and finished products.
2. Conduct analytical testing using instruments such as HPLC, GC, UV-Visible, FTIR, KF, pH meter, dissolution apparatus and other laboratory instruments.
3. Conduct stability studies as per approved stability protocols and schedules.
4. Perform forced degradation studies and impurity/degradation-profile evaluation where applicable.
5. Prepare and execute analytical method validation protocols and reports in accordance with applicable ICH and regulatory requirements.
6. Support analytical method transfer from ADL/R&D to QC and provide technical assistance during implementation. Docthub Jobs
7. Perform routine and developmental analysis and ensure accurate interpretation of analytical results.
8. Troubleshoot analytical methods and instruments and coordinate with instrument service engineers for maintenance/calibration.
9. Investigate OOS, OOT, analytical errors, deviations and laboratory discrepancies and support appropriate CAPA.
10. Prepare/review STPs, specifications, analytical protocols, validation reports, method-development reports, COAs, SOPs and other ADL documents.
11. Maintain laboratory records, instrument logbooks, sample registers and analytical data in accordance with Good Documentation Practices (GDP).
12. Ensure compliance with GLP, GMP, data integrity requirements and applicable regulatory guidelines.
13. Coordinate with R&D, QC, QA, Production and Regulatory Affairs for analytical development and product-related activities.
14. Support internal, customer and regulatory audits/inspections and ensure ADL documentation is audit-ready.
15. Maintain proper housekeeping, safety practices and good laboratory practices within the ADL laboratory.
16. Participate in departmental training and continuously improve analytical methods and laboratory processes.

Required Skills

• Analytical method development & validation
• HPLC and GC operation/troubleshooting
• UV/FTIR and other analytical instruments
• Stability studies
• Forced degradation
• OOS/OOT investigation
• ICH guidelines
• GMP/GLP/GDP
• Data integrity
• Analytical documentation
• Problem solving and troubleshooting