Shankar Bhujangrao Yadav
Sr Executive Quality Control
Silvassa
Summary
To build a challenging career that offers continuous building up and which promotes exposure to Variety of evolving Various Techniques in Pharmaceutical Industries.
Overview
16
16
years of professional experience
9
9
years of post-secondary education
5
5
Certifications
3
3
Languages
Work History
Sr. Executive-QC
Ipca Laboratories Ltd. Silvassa
02.2021 - 06.2025
- Company Overview: Approvals: USFDA, MHRA, WHO.
- -Handling the team of 12 peoples i.e. Lab Technician, Analyst, and HPLC Operator.
- -Looking after Analysis Planning of Finished Goods, Intermediate & Swab Analysis Samples.
- -Responsible for Release of FG, Intermediate Batch, to monitor & supervise the working practices of Analyst.
- -Allocate samples in LIMS & to ensure release of material from SCM, to maintain Inward Logbook & Best Housekeeping practices.
- -To involve in QMS activities & Lab compliance, Online review of raw data & final release of batches in SCM
- -Accountable for Smooth functioning of FG planning & release.
- -Assist in Analysis plan of Validation & Hold time Sample as per requirement
- Job Profile: Section In-charge
Executive-QC
USV Private Limited, Daman
12.2017 - 02.2021
- Company Overview: Approvals: USFDA, MHRA, WHO.
- To perform Review of Instrument Calibration Record & involved in GLP activities, to maintain & up keeping of GLP records & calibration reports also to review of Analytical Document of RM, FG & Stability, Online Review, to Monitor Compliance in QC Laboratory.
- Up keeping of GMP documents & Logbooks also to verify online data recording & documentation.
- To impart training to Analyst, trainee & new joiner.
- Also involved in investigation of OOS, OOT as well any other QMS activities.
- To co-ordinate with Quality Assurance dept. for issuance, Compliance & release of FG & semi FG.
- To create, Lock, Unlock Empower-3, Monthly Project of Each Section.
- Job Profile: Reviewer
Executive-QC
Sun Pharmaceutical Industries Ltd. (Dadra, Nagar & Haveli.)
04.2017 - 12.2017
- Company Overview: Approvals: USFDA, MHRA, WHO.
- To perform Analytical testing of Finished Product, In-process & Stability Samples (i.e. Related Substances, Assay, CU, BU & Dissolution By HPLC (Waters & Shimadzu Make) _Empower 3 Software, Determination of Dissolution by UV Spectra, Documentation i.e. Summary report preparation, to maintain HPLC Column usage logbook, HPLC logbook, proactively participate in cGMP & GLP Practices. Lims Documentation & Compliance. Contribute to OOS/ OOT investigation.
- Job Profile: Analyst -FG
Executive-QC
Alkem Laboratories Ltd., Daman
08.2016 - 04.2017
- Company Overview: Approvals : USFDA,MHRA, TGA, Canada, WHO
- To perform Analytical testing of Stability Samples (i.e. Related Substances, Assay, Dissolution By HPLC (Waters Alliance) _Empower 3 Software, Determination of Dissolution by UV Spectra, Documentation i.e. Summary report preparation.
- Job Profile: Analyst - Stability
Executive-QC
Sun Pharmaceutical Industries Ltd. (Dadra, Nagar & Haveli.)
02.2014 - 07.2016
- Company Overview: Approvals: USFDA, MHRA, TGA, Canada, European Union, ANVISA, WHO.
- To perform Analytical testing of Finished Product, In-process & Stability Samples (i.e. Related Substances, Assay, CU, BU & Dissolution By HPLC (Waters & Shimadzu Make) _Empower 3 Software, Determination of Dissolution by UV Spectra, Documentation i.e. Summary report preparation, to maintain HPLC Column usage logbook, HPLC logbook, proactively participate in cGMP & GLP Practices. Lims Documentation & Compliance. Contribute to OOS/ OOT investigation.
- Job Profile: Analyst - FG
Executive-QC
Centaur Pharmaceuticals PVT. LTD. Hinjewadi (Pune)
03.2013 - 09.2013
- Company Overview: Approvals: USFDA, MHRA, WHO.
- To perform Analytical testing of Stability Samples (i.e. Related Substances, Assay, Dissolution (Electro Lab & Labindia) & Content Uniformity By H.P.L.C. (Dionex & Waters Alliance 2695.) U.V. Spectrometer (Shimadzu U.V.-1700), Autotitrator. (Metrohm 716 DMS).
- Determination of Water content by Karl-Fischer Titrater, Chemical analysis i.e. PH determination Identification, Uniformity of Weight, Average Weight, Hardness Testing, Friability, Disintegration Test, Chromatographic Impurity by TLC Performing In-Process & Finished Product Analysis of Core & Coated Tablets i.e. Dissolution, Disintegration, Hardness, Friability, Assay, RS, CU. by U. V. & HPLC
- Job Profile: Analyst - Stability
Executive-QC
SHANLINA LABORATORIES LTD. Jejuri (Pune)
01.2011 - 03.2012
- Company Overview: Approvals : WHO, Ghana, Kenya, Nigeria, China.
- Analytical testing of Raw Material (RS & Assay) By H.P.L.C. (Agilent & Waters Alliance 2695.) U.V. Spectrophotometer (Shimadzu UV-1601), Potentiometer (Metrohm 716 DMS).
- Identification test by FTIR (Perkin- Elmer), U.V. Spectrophotometer, TLC Techniques & Melting Point Apparatus.
- Determination of Water content by Karl-Fischer Titrater, Preparation & Standardization of Volumetric Solutions. Calibration of Analytical Balance, U.V. Spectrophotometer, FTIR & HPLC.
- Performing In-Process & Finished Product Analysis of Core & Coated Tablets i.e. Dissolution, Disintegration & Assay by U. V. & H. P. L. C. also Dealing with Stability Study. Performing Working Standard Qualification, Maintaining record.
- Job Profile: Analyst - RM
Executive-QC
CIPLA LTD. Kurkumbh. (Pune)
07.2009 - 12.2010
- Company Overview: Approvals : US-FDA, WHO, MHRA, TGA & Brazil
- Analytical testing of Raw Material by U.V. Spectrophotometer.
- Identification test by FTNIR & TLC Techniques.
- Chemical Analysis of Raw Material, Bulk Drug Finished (API) i.e. Bulk Density, Tapped Density Melting Point.
- Calibration of Analytical Balance, U.V. Spectrophotometer, FTIR & Performing Non-Routine Section Documentation. Analysis of Packaging Material & Updating Specifications of packing materials.
- Job Profile: Analyst - RM
Education
M.Sc. - Analytical Chemistry
01.2006 - 04.2008
- Affiliated to Pune University.
- GPA: 56.85%
B.Sc. - Chemistry
01.2003 - 04.2006
- Affiliated to Pune University.
- GPA: 67.00%
H.S.C - undefined
01.2001 - 04.2003
- Maharashtra State Board Of Education (Pune Board)
- GPA: 66.00%
S.S.C - undefined
01.2000 - 04.2001
- Maharashtra State Board Of Education (Pune Board)
- GPA: 66.40%
Skills
Team handling skills
Expertise in QC compliance
Team Leader & teamwork skills
Analytical skills, knowledge of Regulatory inspections
Certification
Certification: - Diploma in "Office Automation "(One year Computer Course. Year- 2001- 2002)
References
- Ashwin, Patel, AGM-QC, 9823595706, 8849639650, Ipca Lab.Ltd.
- Sandip, Patil, Manager-QC, 9979408030, USV Pvt.Ltd.
Interests
Like to play cricket & Chess, Reading Books, Watching Movies
Accomplishments
- -Immediate after complete training I had given contribution to made 65 Hold time study Reports online.
- -Faced US-FDA Surprise audit in Apr-2022 with only 3 QC Observations.
- -Significant contribution in transfer of QC person’s data base in Access management system.
Disclaimer
I hereby declare that the above-mentioned information is correct up to my knowledge and I bear the responsibility for the correctness of the above-mentioned particulars.
Audits Experienced
US-FDA, Local FDA Visit, WHO, MHRA, Merck Party audit, Cipla, Neolab, Ghana.
Timeline
Sr. Executive-QC - Ipca Laboratories Ltd. Silvassa
02.2021 - 06.2025
Executive-QC - USV Private Limited, Daman
12.2017 - 02.2021
Executive-QC - Sun Pharmaceutical Industries Ltd. (Dadra, Nagar & Haveli.)
04.2017 - 12.2017
Executive-QC - Alkem Laboratories Ltd., Daman
08.2016 - 04.2017
Executive-QC - Sun Pharmaceutical Industries Ltd. (Dadra, Nagar & Haveli.)
02.2014 - 07.2016
Executive-QC - Centaur Pharmaceuticals PVT. LTD. Hinjewadi (Pune)
03.2013 - 09.2013
Executive-QC - SHANLINA LABORATORIES LTD. Jejuri (Pune)
01.2011 - 03.2012
Executive-QC - CIPLA LTD. Kurkumbh. (Pune)
07.2009 - 12.2010
Late Shree Ramakrishna More College - M.Sc., Analytical Chemistry
01.2006 - 04.2008
Waghire College - B.Sc., Chemistry
01.2003 - 04.2006
Waghire College - H.S.C,
01.2001 - 04.2003
Harni Madhyamik Vidyalaya - S.S.C,
01.2000 - 04.2001