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3.0 - 7.0 years
0 Lacs
neemrana, rajasthan
On-site
You will be responsible for planning, executing, and documenting analytical method validation activities for raw materials, in-process samples, finished products, and cleaning validation. This includes assessing accuracy, precision, specificity, linearity, robustness, LOD/LOQ, and other parameters. You will review and approve validation protocols and reports in accordance with ICH Q2(R1), USP, and other regulatory standards to ensure compliance. Your role involves ensuring that all analytical method validation (AMV) activities adhere to GMP, GLP, and cGMP guidelines. Collaboration with R&D, QA, and Production teams is essential for seamless tech transfer and validation support. You will troubleshoot analytical method issues, propose enhancements, and recommend revalidations as needed. Maintenance and calibration of analytical instruments such as HPLC, GC, UV-Vis, and FTIR will be part of your responsibilities. In preparation for regulatory inspections and internal audits, you will participate in these processes. Additionally, you will play a key role in training and guiding junior QC staff on method validation procedures and regulatory expectations. It is crucial to ensure the completeness, accuracy, and proper archiving of all documentation as per standard operating procedures (SOPs). This position is based in Giloth, Neemrana, Rajasthan, and requires prior experience in a similar role. The job is full-time and permanent, offering benefits such as commuter assistance and provided meals. The work schedule is during day shifts with a yearly bonus component. The role necessitates on-site presence for work. If you meet the experience requirements and are adept at analytical method validation within a regulated environment, we invite you to apply for this challenging opportunity.,
Posted 1 day ago
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