Prachi Hagawane
Nashik,India
Summary
Detail-oriented and dedicated Quality Control Officer with a strong academic foundation in Organic Chemistry (M.Sc.) and hands-on experience in pharmaceutical testing and documentation. Proficient in operating and calibrating analytical instruments such as UV-Vis Spectrophotometer, FT-IR, and Polarimeter, with a solid understanding of ICH, GMP, and pharmacopoeial standards (IP, BP, USP). Demonstrated ability to perform method validation, manage stability studies, and maintain compliance during regulatory audits including FDA, WHO, and international inspections. Committed to delivering accurate, compliant, and high-quality results in a regulated environment, with strong documentation skills and a passion for continuous learning in the pharmaceutical domain.
Overview
2
2
years of professional experience
4
4
years of post-secondary education
Work history
Quality Control Officer
Sanpras Healthcare Pvt. Ltd.
Nashik, India
12.2023 - Current
- Performed drug release testing using UV-Visible Spectrophotometer in accordance with ICH guidelines.
- Validated analytical methods and maintained working standards for pharmaceutical testing.
- Calibrated and maintained laboratory instruments including UV Spectrophotometer, FT-IR, Refractometer, Polarimeter, Melting Point Apparatus, and UV Cabinet.
- Conducted daily calibration of analytical balances and pH meters to ensure accuracy in test results.
- Prepared and managed documentation such as Certificates of Analysis (COAs), Stability Study Records, and Analytical Test Reports.
- Analyzed various sample types including raw materials, packing materials, stability samples, and R&D formulations.
- Performed wet chemical analysis according to IP, BP, and USP pharmacopoeia standards.
- Maintained and updated Standard Operating Procedures (SOPs), manuals, and quality-related documentation.
- Ensured compliance with GMP standards and supported audits by regulatory bodies including FDA, WHO, and international auditors (e.g., Chile, Uganda).
Training Experience
Arni Analytical Pharmaceutical Training Center
Nashik, India
06.2023 - 06.2023
- Completed hands-on training in analytical techniques including HPLC, UV-Visible Spectrophotometry, Dissolution, and Disintegration at a certified pharmaceutical training center.
- Gained practical exposure to standard operating procedures (SOPs) for handling analytical instruments in compliance with ICH and GMP guidelines.
- Trained in the calibration and maintenance of analytical instruments such as FT-IR, Refractometer, Polarimeter, and Melting Point Apparatus.
- Learned the principles of analytical method validation and documentation procedures for pharmaceutical quality control.
- Acquired skills in stability study documentation, sample preparation, and ppm solution calculations under expert guidance.
- Attended regulatory training sessions on FDA, WHO, and international audit requirements.
- Developed proficiency in preparing Certificates of Analysis (COA) and maintaining analytical records as per industry best practices.
- Underwent training on pharmaceutical documentation standards, including STP preparation and report writing.
Education
M. Sc - Organic chemistry
K.R.T. Arts, B.H. Commerce, A. M. Science (KTHM) College
Nashik 06.2021 - 04.2023
B. Sc - Chemistry
S. V. K. T. Arts, Science and Commerce College
Nashik 06.2019 - 03.2021
Skills
Practical knowledge of Analytical Properties:
- UV-VIS
- Disintegration Test
- FT-IR
- Polarimeter
- Refractometer
- Basic Knowledge of Computer (MSCIT)
Documentation:
- Analytical record
- STP/COA Preparation
- Stability Documentation
- Product Testing Procedures
- Regulatory Compliance
Audit Face
- FDA
- WHO
- International Party Audits (Chile, Uganda)
Area of Interest
- Quality Control
- Quality Assurance
- Research & Development
Languages
English
Fluent
Hindi
Fluent
Marathi
Native
Timeline
Quality Control Officer
Sanpras Healthcare Pvt. Ltd.
12.2023 - Current
Training Experience
Arni Analytical Pharmaceutical Training Center
06.2023 - 06.2023
M. Sc - Organic chemistry
K.R.T. Arts, B.H. Commerce, A. M. Science (KTHM) College
06.2021 - 04.2023
B. Sc - Chemistry
S. V. K. T. Arts, Science and Commerce College
06.2019 - 03.2021
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