Bharat Kumar

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

 

 

 

 

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:

• DMS (Document management system)
• Empower2 and Empower 3
• Chromaleon
• UV probe
• Tiamo
•  

M.Sc. (Analytical Chemistry) : Acharya Nagarjuna University (2008-2010)

B.Sc (MPC) : Lutheran Degree College, Andhra University (2005-2008)

PGDCAQM : University of Hyderabad (2009-2011)