Dhanendra Kumar
Bhiwadi
Summary
To utilize my skills towards a challenging career in growth oriented and leading edge organization that recognizes and values individual contribution and provides opportunities for contributing growth advancement.
Managerial professional with proven record of streamlining processes and leading high-performing teams. Known for strong analytical skills and commitment to achieving results. Teams rely on collaborative leadership and adaptability to changing needs.
Overview
19
19
years of professional experience
Work History
Manager
Aurobindo pharma Ltd
01.2017 - Current
- Allotment of day to day work to team members and work planning
- Analytical release (Approve/Reject) of finished product, raw materials & packing materials
- Timely analysis and release of In-process, packing materials, raw material, Intermediates and finished products as per procedure to support smooth production
- Stability sample analysis completion within the timeline
- Calibration and preventive maintenance of all laboratory instruments
- Empower software administration; Audit trails review, backup project restoration & periodic review
- Audit trail review of standalone instruments (Tiamo software, magic net, Labsolutions TOC control-V Software)
- Responsible for maintaining GLP in QC department
- Review of SOP's and STP's
- Ensuring that all Analytical Instruments are in good working condition and timely completion of AMC's
- Up keeping the laboratory all time ready for regulatory and customer audits
- Review and approval of stability protocol & stability data generated time to time
- Ensuring preparation of AMC & Calibration schedules for the instruments and timely completion of same
- Ensuring qualification of working standard and procuring the reference standard, impurity standards and other laboratory required items
- Investigation the OOS/OOT/OOC occurred in the laboratory
- Responsible for Laboratory Incident investigation, CAPA & Change control
- Responsible for supporting in market complaint investigations
- Responsible for maintaining and continuous improvement on 21CFR compliance
- Coordinating with Production, SCM, QA, warehouse for timely dispatches
- Ensuring that all documentation work is completed on time
- Review and approve the analytical method transfer/validation/verification protocols and reports
- Regularly supporting and providing the data as per the requirement from customer and regulatory
- Involve the regulatory and customer audits to provide the answers for queries
- Training and Qualification of analysts
- Implementation of lean concepts: 5S, Kaizens, Team projects
- Annual goal setting & review for team members
- Handling of external and internal auditors
- Implementation of common procedures & global CAPA against USFDA/EU observations
- Empower On-line Calculation: Implemented 'Paper Less Chromatography'
- Implementation LIMS 3.2.1E caliber
- AUDIT FACED: USFDA, EMEA (INFARMED), ANVISA
Team leader
Dr REDDYS LABORATORIES LTD
10.2010 - 01.2017
QC Officer
R ANBAXY LABORATORIES LTD
02.2008 - 09.2010
QC Chemist
MOREPEN LABORATORIES LTD
12.2006 - 02.2008
QC Chemist
SURYA PHARMACEUTICAL LTD
09.2005 - 12.2006
Education
Master of Science - Industrial Chemistry
Institute of Basic Science, Dr. B.R.A. University
01.2004
Bachelor of Science - Industrial Chemistry, Chemistry, Zoology
Dr. B.R.A. University
01.2002
Intermediate - Science (Bio)
U.P. Board
01.1999
High School - Science
U.P. Board
01.1997
Skills
- Self Confidence
- Positive Attitude
- Punctual
- Decision-making
- Team leadership
- Time management
- Staff training and development
- Task delegation
- Goal setting
- Documentation and reporting
- Relationship building
- Cross-functional teamwork
- Staff development
- Shift scheduling
- Budget control
- Key performance indicators
- Problem-solving aptitude
Languages
Hindi
English
Audits Faced
- USFDA
- EMEA (INFARMED)
- ANVISA
Hobbies and Interests
- Participated in Cultural activities
- Reading News Paper & Magazines
Disclaimer
I hereby declare that the information furnished above are true and complete to the best of my knowledge and belief.
Personal Information
- Father's Name: Shri Suvedar Singh
- Date of Birth: 07/03/83
- Nationality: Indian
- Marital Status: Married
Timeline
Manager
Aurobindo pharma Ltd
01.2017 - Current
Team leader
Dr REDDYS LABORATORIES LTD
10.2010 - 01.2017
QC Officer
R ANBAXY LABORATORIES LTD
02.2008 - 09.2010
QC Chemist
MOREPEN LABORATORIES LTD
12.2006 - 02.2008
QC Chemist
SURYA PHARMACEUTICAL LTD
09.2005 - 12.2006
Bachelor of Science - Industrial Chemistry, Chemistry, Zoology
Dr. B.R.A. University
Intermediate - Science (Bio)
U.P. Board
High School - Science
U.P. Board
Master of Science - Industrial Chemistry
Institute of Basic Science, Dr. B.R.A. University
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