PRIYANKA SATRE
Kandivali (E), Mumbai
Summary
Motivated executive with 8+ years of progressive experience, reliable and driven with excellent organisational, observational and decision-making abilities.
Overview
11
11
years of professional experience
1
1
Certificate
Work History
Sr. Executive R&D
Transasia Bio-Medicals Ltd
Mumbai
2022.06 - Current
- Analyzing and validating prototype of CLIA Instruments as well as kit reagents.
- Planning and executing stability study of kit reagents.
- Executing sample correlation study on internal instrument as compared with reference instrument.
- Leading a team to support R&D Reagent team for assay optimization on CLIA instrument.
- Helping R&D Instrument team in improvisation of instrument.
- Creating purchase order and taking follow up with suppliers.
Quality Control Executive
Yashraj Biotechnology Ltd
Navi Mumbai
2015.06 - 2022.06
- Analyzed and evaluated quality of Intermediate, Bulk and Finished products.
- COA for final products prepared and released.
- Calibration, verification and validation of instruments as well as their preventive maintenance to determine proper functionality.
- Planned and executed stability studies (Accelerated and Real-time) involved in Process validation and Scale-up activities in co-ordination with R&D teams to determine the shelf life and expiration of the product.
- Maintained minimum customer complaints as well as planned & executed experiments other than routine activity for investigation of customer feedback and complaints.
- Guided and monitored execution of the method robustness and validation of existing methods.
- SOP and MQR prepared.
- Validation report, change control record, deviation record prepared and implemented.
- Coordinated quality audits to verify conformance to established quality standards within organization.
Lab Technician
Navi Mumbai Diagnostic Centre
Navi Mumbai
2012.08 - 2014.07
- Blood collection, testing and analysis of samples.
- Result review and ensure no error in reports.
- Record all data and results in specified forms with accuracy and responsibility
Education
M.Sc. Biotechnology -
NIMS University Distance Education Jaipur
Rajasthan2017
B.Sc. Biotechnology -
Karmveer Bhaurao Patil College, Vashi
Navi Mumbai, Maharashtra2012
Skills
- ELISA (Sandwich and Indirect)
- Internal ISO Auditor
- ISO 9001:2015 and ISO 13485:2016 as well as ICH guidelines
- GMP, GLP and GDP.
- Protein Characterization
- ECLIA, CLIA, Immuno-nephelometry and Immuno-turbidimetry
- Quality investigations and problem-solving with analytical skills
Certification
- Workshop for "Biophysical Characterization of Biologics and Biosimilars".
- Quality by Design (QbD) by Dr. Ranjit Barshikar
- Good Manufacturing Practice by Dr. Ranjit Barshikar
- Process and Cleaning validation by Dr. Ranjit Barshikar
Timeline
Sr. Executive R&D
Transasia Bio-Medicals Ltd
2022.06 - Current
Quality Control Executive
Yashraj Biotechnology Ltd
2015.06 - 2022.06
Lab Technician
Navi Mumbai Diagnostic Centre
2012.08 - 2014.07
M.Sc. Biotechnology -
NIMS University Distance Education Jaipur
B.Sc. Biotechnology -
Karmveer Bhaurao Patil College, Vashi
- Workshop for "Biophysical Characterization of Biologics and Biosimilars".
- Quality by Design (QbD) by Dr. Ranjit Barshikar
- Good Manufacturing Practice by Dr. Ranjit Barshikar
- Process and Cleaning validation by Dr. Ranjit Barshikar
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