Bhupendra Kumar Sharma
Quality Control Executive
Greater Noida
Summary
- Precise Analytical Development Lab proficient in all Analytical method operations, policies and procedures. Experience developing individual team members. Committed to thoroughly assessing product quality and manufacturing processes to achieve excellent results and customer satisfaction.
- Methodical as a Researcher with superb problem-solving and analytical abilities. Keeps meticulous records and identify and troubleshoot problems. Specialties include operational improvements, program implementation and documentation.
- A responsible and challenging position that allow me to explore me abilities, skill and sense of dedication toward my duties with the sole aim of seeing the growth of the organization.
Overview
7
7
years of professional experience
Work History
Quality Control Executive
Unicure India Ltd. (Unit-III)
Greater Noida
01.2021 - Current
- Review the stability and Finish Good Electronical raw data, review the all instruments calibration data.
- Maintain the GLP and GDP, troubleshooting of HPLC, GC.
- Preparation of Protocols and Reports (Compendial and Non-compendial methods) of Analytical Method Validation (Assay, Related Substances, Dissolution & Residual Solvents).
- Analytical Method Validation/Verification of Assay, Dissolution, Related Substances and Residual solvents by Gas Chromatography, High performance liquid chromatography.
- Analysis of R&D samples (Trials and new formulations), Stability Samples.
- Experienced in managing the drug regulatory affair’s documents, testing & complaints with addendum protocols and reports.
- Preparation of specification and standard test procedure of Finish Good.
- Developed, Validated/Verified and Successfully transferred methods using HPLC & GC in house.
- Expert problem solver, troubleshooting , investigation and corrective action execution.
Senior Quality Control Officer
Gracure Pharmaceuticals Ltd., Bhiwadi, Alwar, Rajasthan
Bhiwadi
05.2020 - 12.2020
- Experienced in managing Stability Section’s documents, testing & complaints handling with Scientific justifications.
Quality Control Officer
Kusum healthcare Pvt. Ltd. Chopanki, Bhiwadi, Alwar, Rajasthan
Bhiwadi
05.2018 - 05.2020
- Analysis of Assay, Dissolution, Related Substances and Residual solvents by Gas Chromatography, High performance liquid chromatography & Ultra performance liquid chromatography.
- Experienced in managing the drug regulatory affair’s documents, testing(DPDM & Analytical method verification) with addendum protocols and reports.
- Maintain Incident, CAPA, GDP, GLP, OOS, OOT, Calibration Records.
- Maintain Electronic Data and Mata Data, such as audit Trails, for individual computerized systems used in Generation, Processing and Reporting of Data.
- Responsible For Quality Control Compliance with Data integrity Policy and Procedure.
Quality Control Officer
Saurav Chemical Ltd (Unit III), Bhagwanpura, Derabassi, Mohali, Punjab
Derabassi
11.2017 - 04.2018
- Operation and calibration of High performance liquid chromatography (Shimadzu, Waters & Agilent) with (Empower 3 Software).
- Analysis of Assay and Related Substances of Active pharmaceutical ingredients.
Quality Control Chemist
Sirmour Remidies Pvt. Ltd., Paonta Sahib, Sirmor, H.P
Paonta Shahib
09.2015 - 11.2017
- In process quality control of bulk and finish goods testing including assay, dissolution, weight variation, friability, disintegration time, and physical parameters.
- Water Testing.
- Packaging Material testing.
Education
Master of Science - Pharmaceutical Chemistry
HNBGU Garhwal
Shrinagar, U.K.06.2016
Bachelor of Science - Science Education
Gurukul Kangri University
Haridwar06.2014
High School Diploma -
U.P. Board
Allahabad06.2009
Skills
- Data integrity and Lab compliance
- Method development, Validation and Transfer
- GMP documentation, Protocol and Report writing
- Writing/editing/revising STP and SOP
- Team Leadership
- Team Collaboration
- Time Management
- Skilled technical mentor
- Good documentation practices
Reading books
- Motivational books
- Self-helping books
Languages
Hindi
Native language
Hindi
Advanced
C1
English
Upper intermediate
B2
Timeline
Quality Control Executive
Unicure India Ltd. (Unit-III)
01.2021 - Current
Senior Quality Control Officer
Gracure Pharmaceuticals Ltd., Bhiwadi, Alwar, Rajasthan
05.2020 - 12.2020
Quality Control Officer
Kusum healthcare Pvt. Ltd. Chopanki, Bhiwadi, Alwar, Rajasthan
05.2018 - 05.2020
Quality Control Officer
Saurav Chemical Ltd (Unit III), Bhagwanpura, Derabassi, Mohali, Punjab
11.2017 - 04.2018
Quality Control Chemist
Sirmour Remidies Pvt. Ltd., Paonta Sahib, Sirmor, H.P
09.2015 - 11.2017
Master of Science - Pharmaceutical Chemistry
HNBGU Garhwal
Bachelor of Science - Science Education
Gurukul Kangri University
High School Diploma -
U.P. Board
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