Shivnath Rajaram Talekar

1. Analytical Work Planning
Planned and executed analysis of finished products and intermediates using HPLC, GC, and wet chemistry methods


Ensured adherence to approved specifications, test methods, and regulatory guidelines


2. Instrument Handling & Data Review

Checked and verified chromatographic integrations for accuracy and compliance


Maintained system suitability and ensured proper instrument calibration


3. Software Management


Conducted periodic review and compliance checks of:


Empower


Chromeleon


PRO-DRE

Ensured data integrity in accordance with ALCOA+ principles


4. Documentation & Data Compilation


Compiled AWR (Analytical Work Report) data and submitted for QA final review


Prepared, reviewed, and maintained analytical records as per GMP requirements


5. Deviation & Investigation Handling


Initiated and investigated laboratory errors


Handled OOS (Out of Specification) and OOT (Out of Trend) results following SOPs


Performed root cause analysis and implemented CAPA


6. Column & Equipment Management


Maintained HPLC and GC column usage records


Ensured proper storage, usage tracking, and lifecycle monitoring of columns


7. LIMS & Compliance Activities


Raised and managed protocols and formats in LIMS-Caliber


Ensured proper workflow tracking and documentation within LIMS