RAHUL KHARNAR

• Managing teams of In-Process, Finished Product, Stability,Process Validation, Analytical Method Verification/Validation (AMV), Analytical Method Transfer (AMT) and Cleaning Validation.
• Leading investigations of Laboratory incidents, OOS, OOT, deviations and change controls to maintain quality assurance.
• Review of Analytical Method Validation/verification/transfer protocols and reports to ensure compliance with quality standards.
• Review of Process Validation, Packing validation, Hold Time Study protocols and reports to ensure compliance with quality standards..
• Review analytical data, chromatographic data and Certificates of Analysis (C of A).
• Review Specifications (Spec), Standard Test Procedures (STP) and Analytical Work Record (AWR).
• Ensured adherence to quality and regulatory standards set by EU-GMP, SAPHRA, and MCAZ.

• Maintained regulatory standards for USFDA, MHRA, SAPHRA and TGA.
• Validated and verified analytical methods while overseeing method transfer activities, enhancing analytical accuracy and reliability.
• Reviewed analytical data, chromatographic sequences, and audit trails, ensuring compliance with established quality standards.
• Reviewed specifications and STPs; investigated OOS, OOT, and laboratory incidents to identify root causes and implement corrective actions.
• Created HPLC and UV instrument/processing methods and maintained QC documentation and logbooks.

• Prepared analytical method validation/verification protocols and reports to ensure compliance and reliability.
• Prepared specifications and Standard Test Procedures.
• Performed In process,Finished product , process Validation and stability sample analysis.
• Prepared specifications and Standard Test Procedures.

Analyzed stability, semi-finished, and finished product samples to ensure adherence to quality standards.

Collaborated with diverse team to achieve goals and resolve product and service-related issues.

• Completed day-to-day duties accurately and efficiently.
• Contributed innovative ideas and solutions to enhance team performance and outcomes.
• Worked successfully with a diverse group of coworkers to accomplish goals and address issues related to our products and services.

• Analyzed semi-finished, finished, in-process stability, and raw material samples to ensure quality compliance.

• Executed HPLC, UV, and routine analytical testing for timely pharmaceutical sample release.

• Tested raw materials using HPLC, UV, and titration methods for Bliss GVS batches.
• Verified finished pharmaceutical products against specifications and release standards.
• Prepared and standardized reagents for routine laboratory analysis.