Pranali Kulkarni
Pune
Summary
Accomplished Quality Executive with a proven track record at Datar Cancer Genetics, enhancing quality control and assurance processes. Expert in HPLC and adept at fostering team collaboration to resolve quality issues, significantly improving process efficiency. Demonstrates strong leadership in maintaining rigorous quality standards and documentation, ensuring compliance and operational excellence.
Acquainted with the quality management cycle and Corrective Action/ Preventive Action (CAPA) processes.
Overview
5
5
years of professional experience
1
1
Certification
Work History
QUALITY EXECUTIVE
Datar Cancer Genetics
Nashik
10.2021 - 11.2024
- Check the cancer sample, and work on the isolation
- Cancer sample releasing for further report analysis
- Maintain the documents regarding cell culture laboratory
- Collaboration with teams to investigate and resolve process-related quality issues and work towards results driven methods
- Maintain thorough documentation and SOPs, adhering to Good Documentation Practices (GDP) to ensure accuracy and traceability
- Maintaining and creating Lab related documents like monthly form, CAPA, preparation documents for audit like change control documents
- Maintain the register for labs equipment
- Environmental monitoring of lab
- Wet chemical analysis on lab samples in order to ensure quality and consistency of sample results
- Check the quality of Isolation kit NGS kit and store materials with expiry date
- Prepare the GMP related documents, and submit to FDA for approval
- Assist in preparing detailed reports for internal audits and regulatory inspections, ensuring all quality control processes meet required standards
- To schedule the cleaning plan and to monitor environment of Immunocytochemistry, Kit manufacturing Facility, R & D and Diagnostic laboratory after deep cleaning at rest condition
- Isolate the cell free DNA from service sample
- Operate and handle the Quant 5 instrument for performing PCR Run
VALIDATION ENGINEER
S.V Controls
Pune
08.2020 - 09.2021
- To make Design qualifications, Installation qualifications, operational qualifications document for customer like Serum Institutes, Lupin Pharma
- Identification and implementation of new QC guidelines as and when required
- Maintain thorough documentation of testing processes, adhering to Good Documentation Practices (GDP) to ensure accuracy and traceability
- Analyze and interpret data from testing, identify any deviations, and provide solutions to improve product quality
QUALITY INSPECTOR
Fukoku India Pvt LTD.
Pune
01.2020 - 01.2021
- Check quality of manufactured rubber parts and report abnormalities
- Report the activity and provide efficient and pro-active Quality Support and Assistance to the Supply Chain & Production teams
- Organize and plan shift activities according to the workload
- Send regular reports to the regional head of quality control and the site manager about the activities in the lab through standardized tools
Education
M.Sc. - Biochemistry
Ferguson College
Pune, MH01.2018
B.Sc. - Chemistry
Siddhivinayak College
Pune, MH01.2017
H.S.C. -
Borawake College
Srirampur02.2013
S.S.C. -
S.J. Patni Vidyalaya
Srirampur03.2011
Skills
- Quality Control
- HPLC
- Immunohistochemistry
- Real-time PCR
- GC
- Quality Assurance
- Quality management system
- Quality processes
- DNA sequencing
- RNA isolation
- Bioinformatics analysis
- Fluorescence microscopy
- Next generation sequencing
- Gel electrophoresis
- Enzyme assays
- In vitro assays
- Cell culture techniques
- PCR techniques
Personal Information
- Total Experience: 4+ Years
- Date of Birth: 12/11/95
- Gender: Female
- Marital Status: Married
Certification
- Successfully completed ISO 15189 (QMS and Internal Audit) course.
Timeline
QUALITY EXECUTIVE
Datar Cancer Genetics
10.2021 - 11.2024
VALIDATION ENGINEER
S.V Controls
08.2020 - 09.2021
QUALITY INSPECTOR
Fukoku India Pvt LTD.
01.2020 - 01.2021
M.Sc. - Biochemistry
Ferguson College
B.Sc. - Chemistry
Siddhivinayak College
H.S.C. -
Borawake College
S.S.C. -
S.J. Patni Vidyalaya
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