Dec 2018 – Apr 2023 · 4 yrs 4 mos

• Certified by USFDA, MHRA, and other global authorities. Key Responsibilities: Efficiently planned and executed analysis of In-process, Finished Product, and Stability samples within defined timelines. Managed GLP activities including PM schedules, equipment calibration, and preparation of SOPs, working/reference standards. Led planning and execution of Hold Time Studies, Exhibit Batches, and Process Validation sampling as per regulatory guidelines. Designed and executed qualification protocols for Nitrogen and Compressed Air systems. Conducted comprehensive review of analytical data for Raw Materials, Packaging, In-process, Finished Products, Stability, and Water analysis. Effectively handled laboratory incidents, deviations, and ensured timely resolution. Investigated OOT/OOS results in collaboration with QC Head and relevant stakeholders. Prepared analytical worksheets, specifications, STPs, SOPs, and study protocols in alignment with regulatory requirements. Reviewed Water system trends and summary reports for continuous monitoring and compliance. Evaluated and summarized Stability studies to support product shelf-life and regulatory submissions. Reviewed study reports for Protocol-based analyses ensuring accuracy and integrity. Contributed to Regulatory (ANDA) document preparation and review, supporting global submissions. Demonstrated strong team leadership and problem-solving skills across laboratory operations. Possess hands-on experience in Water System Validation and routine monitoring. Performed specialized analysis of Iron Sucrose Complex Solution for Exhibit and Process Validation batches.

Dec 2018 – Mar 2023 · 4 yrs 3 mos · Ahmedabad, Gujarat, India · On-site

May 2017 – Dec 2018 · 1 yr 7 mos · Halol, Gujarat, India · On-site

• Quality control Executive

May 2017 – Dec 2018 · 1 yr 7 mos

• Certified by WHO-GMP, USFDA, and various global regulators. Key Responsibilities: Compiled and reviewed analytical documentation for regulatory and internal use. Conducted cleaning validation activities as per cGMP guidelines. Performed physical testing of Finished Products and In-Process samples. Executed HPLC method transfer for Finished Product analysis. Carried out routine analysis of In-Process and Finished Product samples to ensure quality compliance.

May 2014 – May 2017 · 3 yrs · Ahmedabad, Gujarat, India · On-site

• Senior Executive

Feb 2013 – Apr 2014 · 1 yr 2 mos · Ahmedabad, Gujarat, India · On-site

• Quality control officer

Feb 2013 – Apr 2014 · 1 yr 2 mos

• Certified by WHO-GMP & USFDA. Key Responsibilities: Performed analysis of Raw Material and Packaging Material samples as per approved specifications. Conducted analytical balance calibration to ensure accuracy and reliability of measurements. Carried out sampling of Raw and Packing Materials in compliance with GMP protocols. Prepared and standardized Volumetric Solutions and analytical reagents for routine laboratory use.

Jun 2012 – Feb 2013 · 8 mos · Kheda, Gujarat, India · On-site

• Quality control officer

Jun 2012 – Feb 2013 · 8 mos

• Certified by WHO-GMP and FDA. Key Responsibilities: Performed analysis of Finished Product and In-Process samples to ensure compliance with quality standards. Conducted daily and monthly calibration of analytical balances to maintain measurement accuracy. Executed water sampling and comprehensive water analysis as per regulatory requirements. Carried out raw/packing material sampling following standard GMP procedures. Prepared and standardized Volumetric Solutions and analytical reagents for laboratory testing.