Senior Analyst
Job Description Summary
Responsible for performing complex analytical activities, reviewing and interpreting data, ensuring compliance with applicable procedures and regulatory requirements, and providing technical guidance to team members. The role involves executing and reviewing laboratory analyses, investigating atypical results (OOS/OOT/OOA), supporting method validations and stability studies, preparing technical documentation, and driving continuous improvement initiatives. The Senior Analyst collaborates with cross-functional teams to resolve quality-related issues, maintain data integrity, ensure timely completion of assigned activities, and support regulatory inspections and audits while adhering to current GMP and company quality standards.Job Description
- Perform routine, stability, validation, and investigation sample analysis using HPLC, GC, UV-Visible Spectrophotometer, Dissolution Apparatus, TOC, and other QC laboratory instruments.
- Execute analytical testing of raw materials, packaging materials, in-process samples, finished products, and cleaning validation samples as per approved specifications and test methods.
- Ensure accurate documentation of analytical results in compliance with GDP, cGMP, and data integrity requirements.
- Prepare and standardize volumetric solutions, reagents, and reference standards as per established procedures.
- Investigate OOS, OOT, OOA, deviations, and laboratory incidents.
- Participate in audit and inspection readiness activities.
- Drive continuous improvement and laboratory efficiency initiatives.