Shivanjali Nimbalkar

Quality Control professional with over 8 years of experience in pharmaceutical and cosmetic industries. Strong expertise in wet chemistry, HPLC, GC analysis, analytical method validation and verification, LIMS optimization, OOS/OOT investigations, and GMP-compliant documentation.

QC Executive - Savvy Care and Cosmetics Pvt. Ltd. - Rabale, Navi Mumbai

(2024-10)

• Prepared analytical method validation protocols and reports as per regulatory requirements
• Drafted and reviewed SOPs, raw material specifications, and finished product specifications
• Reviewed analytical documents and ensured proper compilation and compliance
• Investigated laboratory incidents and OOS/OOT results in coordination with QA and QC teams
• Performed analysis of finished products to ensure conformance to specifications

Senior QC Officer - Flamingo Pharmaceutical Ltd. - Taloja, Navi Mumbai

(2024-04 - 2024-06)

• Prepared analytical method validation protocols and reports
• Conducted routine analysis of in-process samples and raw materials
• Ensured laboratory compliance with quality standards

Senior QC Officer - Galentic Pharma (I) Pvt. Ltd. - Rabale, Navi Mumbai

(2020-07 - 2024-04)

• Performed wet and instrumental analysis of raw materials, bulk samples, and finished products
• Executed analytical method validation and verification activities by HPLC for RM and FP
• Performed scheduled calibration of all QC instruments
• Optimized and implemented LIMS software within the QC laboratory
• Prepared masters for raw materials, bulk and finished products in LIMS
• Followed GMP and Good Documentation Practices as per SOPs

QC Officer - Sai Tech Pharmaceutical Pvt. Ltd. - Koparkhairane, Navi Mumbai

(2018-04 - 2020-07)

• Executed analytical method validation of residual solvents by GC in collaboration with QC Head
• Conducted sampling of raw materials and intermediate products
• Performed daily and monthly calibration of QC instruments to maintain accuracy and reliability

QC Chemist - Great Pacific Export Pvt. Ltd. - Turbhe, Navi Mumbai

(2016-03 - 2017-12)

• Sampling and analysis of raw materials and water
• Daily and monthly calibration of QC instruments
• Study of volumetric solution stability and maintenance of related records
• Documentation and maintenance of all QC records

M.Sc. - Organic Chemistry - Yashwantrao Chavan Institute of Science (2015)

B.Sc. - Chemistry - Yashwantrao Chavan Institute of Science (2013)

HSC - Yashwantrao Chavan Institute of Science (2010)