Monali D. Ingole
QUALITY CONTROL AND QUALITY ASSURANCE EXECUTIVE.
Kharghar,Navi Mumbai
Summary
A Versatile QC/QA Executive offering 5-year track record of overseeing and managing Quality operations to meet business objectives. Seeking challenging career opportunities, determined to establish myself in the Quality Control field within the esteemed Pharmaceutical and Chemical Industry. Strong desire to contribute to the success of a reputable company, aiming to leverage skills and knowledge in ensuring the highest standards of quality and compliance.
Overview
5
5
years of professional experience
2054
2054
years of post-secondary education
3
3
Languages
Work History
Executive Quality Control and Quality Assurance
Bhavika chemicals corporation
02.2020 - Current
- Company Overview: approved in chemical and instrument testing
- To follow all instruction and direction given by management for timely completion of the assign task
- Overall accountable for GMP, RM, PM, FP, Stability and documentation for market handling of customer complaint
- To coordinate with R and D, QA and Production for the proper planning and the execution of exhibit and commercial batches for market
- To ensure the timely launch of new product in market by having effective coordination with concern people
- Responsible for review and approval of Raw material, packing material, Semi finished and finished product
- To review and approval of certificate of analysis/trend report after completion of review of raw data of raw material, packing material and finished product
- To ensure proper filing of the report and keeping all documents at its proper place
- Preparation and review of protocol and report for cleaning validation and analytical method validation and supporting documents
- Review the protocol for process validation
- Coordinate with other section /department on day-to-day basis for timely data collection, timely review and release of RM and PM
- To ensure timely release of FP batches for distribution in market
- Evolution of incident, deviation and change control
- Responsible to investigate OOS/OOT in quality control department
- To ensure and review of compliance of GLP in QC lab
- To ensure and review of calibration and AMC of all QC instrument as per schedule
- To ensure internal and external audit compliance
- To review of SOPs, Specification and worksheet of RM, PM, FP and coordinate with other dept
- To fulfill RA requirements
- To monitor and review daily activity of QA and QC/Production for their effective work and compliance
- To ensure that day to day work planning does not affect when the repartees are on leave
- To conduct training classes to QA/QC person
- To evaluate, discuss and submit the performance appraisal of subordinate staff to head acquirement
- Having very good hand on analytical instruments
- Having good knowledge of QA related documents
- Perform elementary method analysis and development for troubleshooting purposes
- Make recommendations to technical support on analytical methods
- Perform all miscellaneous analytical testing as Methods Development Chemist and Analytical Services
- Work in analytical testing labs with hazardous and toxic chemicals
- Perform instrument calibration (IQ/OQ/PQ) and routine equipment maintenance/repair
- Approved in chemical and instrument testing
Education
Master of Science - life sciences biotechnology
Mumbai University
Kalina Santacruz 04.2001 - 01.2018
Bachelor of Science - chemistry
Smt. Chandibai Himathmal Mansukhani College
Ulhasnagar, India 04.2001 - 01.2016
High School Diploma -
New English High School & Junior College
Ulhasnagar, India 04.2001 - 01.2013
S.S.C -
Takshashila Vidyalaya
Ulhasnagar, India06-2011
Skills
Customer relations
Present Experience
02/01/20, Bhavika chemicals corporation, Ambernath, Ambernath, Maharashtra, Executive Quality Control and Quality Assurance, To follow all instruction and direction given by management for timely completion of the assign task., Overall accountable for GMP, RM, PM, FP, Stability and documentation for market handling of customer complaint., To coordinate with R and D, QA and Production for the proper planning and the execution of exhibit and commercial batches for market., To ensure the timely launch of new product in market by having effective coordination with concern people., Responsible for review and approval of Raw material, packing material, Semi finished and finished product., To review and approval of certificate of analysis/trend report after completion of review of raw data of raw material, packing material and finished product., To ensure proper filing of the report and keeping all documents at its proper place., Preparation and review of protocol and report for cleaning validation and analytical method validation and supporting documents., Review the protocol for process validation., Coordinate with other section /department on day-to-day basis for timely data collection, timely review and release of RM and PM., To ensure timely release of FP batches for distribution in market., Evolution of incident, deviation and change control., Responsible to investigate OOS/OOT in quality control department., To ensure and review of compliance of GLP in QC lab., To ensure and review of calibration and AMC of all QC instrument as per schedule., To ensure internal and external audit compliance., To review of SOPs, Specification and worksheet of RM, PM, FP and coordinate with other dept. to fulfill RA requirements., To monitor and review daily activity of QA and QC/Production for their effective work and compliance., To ensure that day to day work planning does not affect when the repartees are on leave., To conduct training classes to QA/QC person., To evaluate, discuss and submit the performance appraisal of subordinate staff to head acquirement., Having very good hand on analytical instruments., Having good knowledge of QA related documents., Perform elementary method analysis and development for troubleshooting purposes., Make recommendations to technical support on analytical methods., Perform all miscellaneous analytical testing as Methods Development Chemist and Analytical Services., Work in analytical testing labs with hazardous and toxic chemicals., Perform instrument calibration (IQ/OQ/PQ) and routine equipment maintenance/repair.
Instrument Handling
- GAS CHROMATOGRAPH, Agilent 7820 A, Agilent, Ez Chrome Elite
- Chromlite GC 3000 A, Netel India, Clarity Lite
- HPLC, Agilent 1260 infinity, Agilent, Ez Chrome Elite
- UV SPETROPHOTO METER, Lambda 25, Perkin Elmer, Uv win lab
- Karl Fischer Titrator, Veego, Veego, -
- Melting Point Apparatus, Veego, Veego, -
- Other General laboratory instruments
Disclaimer
All above given information is true to the best of my knowledge & belief.
Personal Information
- Father's Name: Deorao S. Ingole
- Husband's Name: Saurabh P Dhakne
- Date of Birth: 05/13/95
- Gender: female
- Nationality: Indian
- Marital Status: Married
Timeline
Executive Quality Control and Quality Assurance
Bhavika chemicals corporation
02.2020 - Current
Master of Science - life sciences biotechnology
Mumbai University
04.2001 - 01.2018
Bachelor of Science - chemistry
Smt. Chandibai Himathmal Mansukhani College
04.2001 - 01.2016
High School Diploma -
New English High School & Junior College
04.2001 - 01.2013
S.S.C -
Takshashila Vidyalaya
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