Quality Control Assurance
Resume:
DHANANJAY GOPAL PATIL
Senior Quality Control Officer
Phone number: +91-950*******
Email address: *******@*****.***
Address: At. Lowjee, Post. Khopoli, Tal. Khalapur, Dist. Raigad, Maharashtra PROFESSIONAL SUMMARY
Detail-oriented and results-driven Quality Control Officer with over 5 years of experience in analytical testing, laboratory procedures, and quality assurance. Expertise in testing raw materials, in-process samples, and finished products using advanced instruments such as HPLC, UV-Vis spectrophotometers, and pH meters. Skilled in method validation, OOS investigations, root cause analysis, and instrument calibration (HPLC, UV, pH). In-depth knowledge of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and US FDA regulations. Proven ability to ensure compliance, improve quality systems, and deliver accurate, high-quality results under tight deadlines. Adept at cross-functional collaboration, team leadership, and implementing continuous improvement initiatives to enhance laboratory efficiency and product quality. PROFESSIONAL EXPERIENCE
Enaltec Labs Private Limited (API – US FDA Approved Plant), Ambernath Position: Quality Control Officer
Dates: May 2020 – Present
Key Responsibilities:
Analytical Testing: Perform routine and non-routine testing of raw materials, in-process, and finished products (HPLC, UV-Vis, pH meters) per US FDA and ICH guidelines.
Instrument Calibration & Maintenance: Oversee calibration, qualification, and maintenance of laboratory instruments.
Quality Assurance Compliance: Ensure adherence to GMP, GLP, and regulatory standards.
Data Review & Reporting: Review raw data and prepare detailed reports for continuous improvement.
Sampling & Documentation: Manage sampling, documentation, and support timely product releases., including batch records, certificates of analysis (COA), and laboratory notebooks. Instruments Handled:
HPLC: Shimadzu LC-2010, LC-2030, Waters e2698
UV Spectrophotometer: Shimadzu UV-1800
Other Instruments: pH meter (Mettler Toledo, Lab India) Radiant Chemicals Private Limited, Ambernath
Position: Quality Control Chemist
Dates: June 2017 – January 2020
Key Responsibilities:
Routine Testing & Analysis: Conduct routine chemical testing and analysis to ensure compliance with specifications.
Wet Chemistry Analysis: Performed limit tests, Sulphated Ash, Loss on Drying (LOD), Residual Organic Impurity (ROI), and other chemical analysis techniques.
Documentation & Compliance: Maintained strict adherence to GMP documentation practices. Prepared and reviewed laboratory test reports, certificates of analysis, and batch records.
Calibration & Maintenance: Managed the calibration and maintenance schedule for laboratory equipment and instruments to ensure accurate test results and minimize downtime.
Audit & Inspection Preparation: Assisted in preparing for internal and external audits, including the collection of required documentation and review of laboratory data. PROFESSIONAL QUALIFICATION
Masters in Science (M.Sc.) in Chemistry
Arunodaya University, Arunachal Pradesh; Passing Year: 2019
Bachelor of Science (B.Sc.) in Chemistry
Shivaji University, Kolhapur, Passing Year: 2015
Intermediate of Science (Class 12th)
Dhananjay Junior College, Pune Board, Passing Year: 2011
Matriculation (Class 10th)
B.D.V.D. School, Chandgad, Dist. Kolhapur, Pune Board, Passing Year: 2008 SKILLS & EXPERTISE
Analytical Testing & Quality Control
Instrument Calibration (HPLC, UV, pH Meters)
Wet Chemistry & Chemical Analysis
Good Laboratory Practices (GLP)
Cross-functional Team Collaboration
Documentation & Compliance
Fast Learner & Adaptable
Time Management & Prioritization
PERSONAL DETAILS
Date of Birth: 1st October 1991
Nationality: Indian
Marital Status: Single
Languages: English, Marathi, Hindi
Permanent Address: At/P. Rampur, Tal. Chandgad, Dist. Kolhapur DECLARATION
I hereby declare that the information provided is true to the best of my knowledge. Date: Dhananjay Gopal Patil
Place: (Signature)
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