Bharat Kumar

Analyst in Quality control deartment

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Visakhapatnam, VisakhapatanamMember since November 25, 2022

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Subject

Resume for the suitable position in Analytical Department(Quality Control Department)

I would like to introduce myself Bharat kumar.N working as Asst. Manager in Analytical department at MAHI Drugs Private Limited, Vishakapatnam.I was working as a Research Associate-4 in Aurobindo Pharma Limited, I was working as Research Associate-2 in Lupin Pharma Limited. I have 11.0 years experience in Analytical department. Hereby I have enclosed a copy of my resume to serve as a reminder of my background with additional information about my qualifications and experiences.

I believe there would be a good fit between my skills and interests and your need. Hence, I humbly request you to give an opportunity to be a part of your well esteemed organization. I am waiting to hire from you about the employment opportunity soon.

Thanking you Sir.

Regards,

Bharat kumar.N

Experience

BHARAT KUMAR. NEKKANTI

Passport No.: H6744528

Objective:

To work and grow in the challenging field of Analytical, DQA to contribute my knowledge, skills and personnel commitment to my organization and to continuously strive for professional excellence.

Work Experience:

Ten years in Pharmaceutical sector

Current Job Description and Responsibilities:

Review of verification and validation protocols, reports, and related raw data.
Initiate, upload and implementation of compliance related SOP’S.
Review of Instruments calibration reports
Knowledge on data integrity and GLP aspects.
Review of IQ/OQ/PQ documents.
Monitoring and checking of Instruments logbooks.
Preparation and updating of guidelines GTP’S.
Provide training to new employees and existing employees and maintaining Manpower training records.
Review of product development reports and related data.
Initiate closing and maintain of Laboratory incident records.
Preparation of CAPA reports, Handling of OOS and deviations and preparing the investigation reports of same.
Participation in internal audits.
Knowledge on data integrity and GLP aspects.
Handling of regulatory queries.
Work experience with GLP environment or regulatory environment.
Involving in the plant OOS/OOT/ investigation and its documentation and reporting with respect to GMP norms.
Responsible for frequent Auditing of Analytical Department as per self-inspection and also to ensure compliance against previous audit observations.
Understanding of Laboratory information system, to perform the various operations.
To indent the required glass ware, chemicals and columns for the ARD projects and other duties as assigned.
Plan, organize, perform and document analytical activities including Assay and dissolution method development following GLP.
Validation planning and follow up, Documents release & control

Previous Job Profile & Responsibilities:

Performed analysis of Raw material, Reaction-monitoring, Intermediate, Drug substances as per STP & Respected Pharmacopoeias.
Verifications of compendia methods for quantification assays and related substances by HPLC.
Performing Stability analysis of Drug substances.
Performing Stability analysis of Drug substances.
Ensuring Technology transfer of Drug substances to Quality Control in Plant locations.
Performed Analytical Method validation for related substances and assay by HPLC methods.
Preparation of protocols and Reports for analytical quantification of validation methods.
Online checking/Reviewing of Analytical documents/Records followed as per cGMP, 21CFR and against Specification.
Analysis of samples as per regulatory documents (Ex; 21 CFR, ICH, Schedule L1 and USFDA guidelines).

Technical Skills: