Bhagyashri Yogesh Duse
Clinical Document Analyst
Indore
Summary
Intend to build a career with a leading Corporate and with Committed and dedicated people, which will help me to explore myself fully and realize my potential. Seeking to have a life long relationship with organization, in the process of learning and growing with it.
Clinical data professional with proven track record in data management and analysis. Highly reliable with focus on team collaboration and achieving results, adaptable to changing needs within clinical environments. Expertise in statistical software, data cleaning, and ensuring data quality.
Overview
15
15
years of professional experience
6
6
years of post-secondary education
3
3
Languages
Work History
Clinical Data Analyst
Clean SAS
04.2020 - Current
- Enhanced data accuracy by implementing rigorous validation processes and quality control measures.
- Established strong relationships with internal stakeholders such as statisticians, project managers, and clinicians for seamless collaboration on projects.
- Optimized clinical trial efficiency through meticulous data analysis and interpretation.
- Developed custom algorithms for complex data analysis, leading to actionable insights and better decision-making in clinical trials management.
Validation Sr. Officer
Wockhardt Biotech Park
12.2012 - 01.2015
- Monitoring the cGMP in plant & maintaining the areas
- SOP management and implementation to the respective areas
- Preparation and execution of qualification protocol (IQ, OQ and PQ)
- Perform the HVAC requalification of Oral solid facility
- (Air velocity, Air changes per hour, Filter integrity test, Particle count and Environmental monitoring)
- Cleaning Validation: Tracking of sampling at all stages during cleaning process and subsequently verification of results
- Check and verify the calibration of Validation Instruments i.e
- Tachometer, Sound level meter, Lux meter, anemometer and Digital stop watch
- Deviation Handling: Responsible for logging and investigation for deviations
- Responsible deriving CAPA based on root cause
- Investigation of deviations as a part of cross functional team
- Carrying out CAPA effectiveness review
- Change Controls: Responsible for logging and defining action items for the changes
- Ensuring all the action plan of the proposed change are completed within the timeline
- Ensuring effectiveness of implemented changes
- Self Inspection: Carrying out self inspection as part of inspection team
- Review of response to observations cited during inspection
- Ensuring timely closure self inspections
- Co-ordination with different departments for smooth functioning
- Properly listed and arrange the Validation documents at documentation cell
- Review the qualification documents during audit of USFDA and MHRA
Industrial Trainee
Gentharma Pharma (International) Pvt Ltd
01.2010 - 01.2010
Education
H.S.C. -
K. R. Kotkar College
01.2007 - 01.2008
S.S.C. - undefined
Aanandibai Bankat High school
01.2005 - 01.2006
B.Pharmacy -
Marathwada Mitra Mandal’s College of Pharmacy
07.2008 - 07.2012
Skills
- Logical thinking & Positive attitude
- Effective communicative skill and leadership quality
Extra Curricular Activities
Participated in ‘AVISHKAR 2010’ Zonal level research project competition for under graduates at SGRS College of Pharmacy Saswad Pune. Participated in poster presentation at Siddhant College of Pharmacy, Pune for National Pharmacy week in 2008.
Training
Gentharma Pharma (International) Pvt Ltd, Pune, 2010, 1 month
Disclaimer
I hereby declare that the above-mentioned information’s are authentic and true to the best of my knowledge.
Personal Information
- Husband's Name: Mr. Yogesh B. Duse
- Date of Birth: 06/10/90
- Nationality: Indian
- Marital Status: Married
Timeline
Clinical Data Analyst
Clean SAS
04.2020 - Current
Validation Sr. Officer
Wockhardt Biotech Park
12.2012 - 01.2015
Industrial Trainee
Gentharma Pharma (International) Pvt Ltd
01.2010 - 01.2010
B.Pharmacy -
Marathwada Mitra Mandal’s College of Pharmacy
07.2008 - 07.2012
H.S.C. -
K. R. Kotkar College
01.2007 - 01.2008
S.S.C. - undefined
Aanandibai Bankat High school
01.2005 - 01.2006
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