Sumit Kumar

To be associated with a challenging & innovative environment where my knowledge, idea & potency can be implemented as well as enhanced and to be part of a team that dynamically work towards the growth of organization.

I have consistent academic and extra-curricular track record. I possess excellent analytical and leadership skills. I would like to work with an organization, which gives me complete business prospect

Empower-3, Chameleon, LC solution, Caliber LIMS, Nichelon, QMS 6.1, EPIQ, MS Office (MS Excel, Word), HPLC (Waters, Agilent and Shimadzu), KF Autotitrator, Dissolution Apparatus, Disintegration test apparatus, Friability test apparatus, UV Spectrophotometer, Conductivity Meter, Melting range apparatus, Viscometer, FT-IR Instrument

• LC-MS/MS Triple Quadrupole (Waters e2695 & Acquity TQD and Shimadzu LCMS8060 with ESI and APCI)
• HPLC-Waters e2695 separation module
• UHPLC-Waters AcquityRArcTM and UPLC-Waters AcquityUPLC H-Class
• HPLC-UV/VIS & PDA (Shimadzu Prominence-i LC-2030C Plus and LC-2010)
• Preparative HPLC (Shimadzu LC-20AP with SPD-M20A)
• Detector-UV/VIS-Waters 2489, PDA-Waters 2998, FLR-Waters 2475
• ICP-OES Thermo scientific
• IC Metrohm
• AAS Agilent

• Got TOM (Talent of month) and Appreciation for zero 483 in USFDA audit at Eugia.
• Appreciation from Eugia for reducing of Human error at Eugia Pharma.
• Got mudra and appreciation for successful implementation of Video base training in Quality control at Eugia pharma.
• Successful establishment of LIMS implementation.
• Got mudra and appreciation for Successfully implementation of Corporate procedure at site.

• Date of Birth: 05/08/94
• Gender: Male
• Nationality: Indian
• Marital Status: Married

• English
• Hindi

Faced various Regulatory Bodies Audit like USFDA, AN VISA, NSF, WHO, EU and Various international & Domestic customer Audit. Pre Verification of all production documents. To help in Schedule monitoring. Timely information to management.

• Successfully appeared for and cleared the Government FDA interview conducted in Dehradun, Uttrakhand, for the Quality Control Department, and was subsequently awarded the designation of Approved Chemist in the Chemical, Microbiology, and Instrumentation sections.
• Drove efforts towards successfully implementing control over Computerized System to maintain data integrity.
• Promoted and introduced Electronic signature for Empower, Tiamo and Lab Solution software.
• Worked towards improving Quality System for the compliance and strengthens the procedures like electronic data management/Audit trail review.
• Played a key role in the implementation and deployment of LIMS (Process flow creation and qualification to effectively manage the flow of samples and associated data, master creation, module development like: standard management, column management).
• Active involvement and implementation of Track wise (for QMS)/ Documentation (To store, track and manage master document electronically).
• Rich exposure of participating in successful regulatory audits like USFDA, TGA, MHRA, ANVISA, EUcGMP.
• Led the Quality Control Team with achieving the TCD.
• Excellent of self-motivated team player with good communication and interpersonal skill couple with strong analytical and problem solving ability.
• Conduct SOP related trainings and ensures all training need are met. Develop capability of subordinate through providing functional and technical guidance.
• Promotes and encourages a work environment that challenges employees to constantly search for ways to perform their activities more efficiently and effectively.
• Manages the activities of the quality control department to create a culture of quality awareness, teamwork, and cooperation with all departments within the Facility.
• Ensures that all safety procedures are understood and followed by providing up to date safety training to all employees and auditing procedures.
• Identify best practices and provide appropriate feedback to Management and training department, including corrective and preventive actions.

• Led the Lab compliance team (Including 10 persons) for timely completion of activity of quality control by overseeing accurate laboratory testing and review of reports/results/COA.
• Acted as an investigator to conduct the laboratory investigations like Out of specification (OOS) and Out of trend (OOT).
• Review of laboratory investigations of OOS, OOT, Incidents & Deviations in QC.
• Reviewed quality control documents like instruments and equipment usage, log books and working standard consumption log books for verification of the data.
• Assured Quality control laboratory compliance and working on laboratory instruments like HPLC (High Performance Liquid Chromatography), KF Autotitrator, Dissolution Apparatus, Disintegrator and Fibrilator, UV and FT-IR Instrument respectively.
• Ensured preparation and review of Computer System Validation deliverables including URS/IRA/Validation Plan/FRS/IQ/OQ/PQ/Validation reports.
• Ensured and review of daily & monthly calibration of all analytical balances used for analysis to vary their working condition.
• Periodic review of audit trail of standalone instrument.
• Periodic review of QC GXP system and ensured smooth implementation as per CAPA requirement.
• Responsible for review of Quarterly trending of Laboratory incidents, Out of specification and Out of trend.
• Responsible for preparation of monthly and quarterly trending of Empower message center.
• Performed Planning and review of Conducted analysis of stability samples by using of chromatography techniques.
• Document organize, interpret utilizes and review data in order to arrive at scientifically supportable conclusion.
• Ensure safety at the laboratory by providing relevant guidelines/training/resource to the team and monitoring their adherence to SOPs.
• Coordinate with contract labs for timely submission of samples for testing and follow up of reports.
• Manage review & approval of stability summary report and stability protocol.
• Participated in Quality Review Board Meetings to supervise and discuss monitoring of compliance health of site and monitored KPIS on a monthly basis and ensured escalation within time to report the same to Global Quality management.
• Coordinated with cross-functional teams inclusive of Quality and Regulatory needs to proactively resolve the internal & external guidelines and regulations respectively.
• Based on technology trend information to assist in developing idea generation sessions for new concepts and implementation.