Shital Jadhav

Operations Associate

Pune, Maharashtra, India13 yrs 2 mos experience

Highly Stable

Key Highlights

Over 13 years in Pharmaceutical Quality Assurance
Expert in data analysis and compliance management
Proficient in statistical tools and quality management

Stackforce AI infers this person is a Quality Assurance Specialist in the Pharmaceutical industry.

Contact

Skills

Core Skills

Quality ManagementGood Manufacturing Practice (gmp)

Other Skills

Analytical SkillsAuditingBusiness AnalysisCause & EffectCompliance ManagementInternal AuditsLeadershipProblem SolvingPython (Programming Language)Quality ControlRisk AnalysisSQLStatistical Analysis ToolsTeam Leadership

About

13+ years of diverse experience in QC/QA of Pharmaceutical field. Seeking a challenging career that leverages my technical and analytical skills to broaden and enhance my current knowledge while providing job satisfaction and opportunities for self-development. Proficient in utilizing Microsoft Excel for tracking compliance activities, Skilled in analyzing data sets, identifying trends, providing actionable insights through impactful presentations. Strong problem-solving and communication skills with a focus on delivering business value through data-driven decisions.

Experience

Deccan nutraceuticals private limited

Executive Quality Assurance

May 2020 – Mar 2022 · 1 yr 10 mos · Pune, Maharashtra, India · On-site

Review Quality Data and Audit Trail of Instruments, Daily QC rounds to ensure compliance.
Reviewed computer system validation (CSV) documents.
Handled incidents, deviations, change controls, OOS (Out of Specification), and OOT (Out of Trend) events.
Handled Corrective and Preventive Action Reports (CAPA).
Prepared Annual Product Quality Review (APQR).
Conducted internal audits, ensuring compliance with Good Manufacturing Practice (GMP) standards.
Led problem-solving and risk analysis initiatives to improve quality management.
Prepared and presented reports and visualizations using Excel for data-driven decision-making.
Participated in Quality Review Meetings (QRM) to review and assess the effectiveness of quality control processes and identify areas for improvement.
Contributed to Management Review Meetings (MRM) by providing data-driven insights and analysis on quality performance and decision-making.
Qualified trainer for QMS.

Internal AuditsCause & EffectRisk AnalysisProblem SolvingStatistical Analysis ToolsQuality Management+2

Megafine pharma (p) ltd.

Jr. Manager Quality Assurance

Oct 2015 – Aug 2018 · 2 yrs 10 mos · Nashik, Maharashtra, India · On-site

Review quality-related data and performed risk analysis to optimize quality management processes.
Handled customer audit responses.
Conducted internal audits, ensuring compliance with Good Manufacturing Practice (GMP) standards.
Led cross-functional teams to implement process improvements and ensure compliance with industry
regulations.
Prepared and presented reports and visualizations using Excel for data-driven decision-making.
Participated in Quality Review Meetings (QRM) to evaluate the effectiveness of quality control
measures and recommend enhancements.
Contributed to Management Review Meetings (MRM) by providing data-driven insights and analysis
on quality performance and decision-making.
Qualified trainer for QMS.

LeadershipInternal AuditsTeam LeadershipCause & EffectRisk AnalysisProblem Solving+4

Sai life sciences ltd

Sr. Research Associate

Jan 2011 – Sep 2015 · 4 yrs 8 mos · Pune, Maharashtra, India

Conducted research and analysis, focusing on Good Manufacturing Practice (GMP) and quality management.
Contributed to risk analysis and quality management processes.

Risk AnalysisQuality ManagementGood Manufacturing Practice (GMP)

Sterling healthcare pvt ltd

Quality Control Officer

Sep 2009 – Dec 2010 · 1 yr 3 mos · Pune, Maharashtra, India · On-site

Sampling, testing and reporting results of RM, PM, Stability and Finished product.
Handling experience of ERP Software for preparation of Finished, Raw materials STP and Specifications.
Ensured compliance with GMP standards through quality control practices.

Quality ManagementGood Manufacturing Practice (GMP)Quality Control

Glenmark pharmaceuticals

Quality Control Officer

Feb 2008 – Dec 2008 · 10 mos · Goa, India · On-site

Reviewed stability reports.
Managed stability samples and compiled stability data.
Handled OOS (Out of Specification) and OOT (Out of Trend) events.

Quality ManagementGood Manufacturing Practice (GMP)Quality Control

Healing cross pharma

Quality Control Officer

Dec 2005 – Sep 2007 · 1 yr 9 mos · Daman and Diu, India · On-site

Sampling and analysis of API, Excipients, Finished, stability and inprocess samples.
Preparation of Volumetric solutions and volumetric solution stability protocol
Water system validation and Routine analysis of water, Preparation of Water trend.
Process validation
Calibration of HPLC, Balances, KF Titrator, Halogen moisture analyzer, UV Spectrophotometer,IR
Spectrophotometer, Friability tester, DT and Dissolution apparatus.
Maintained compliance with GMP standards.

Quality ManagementGood Manufacturing Practice (GMP)Quality Control