About 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
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:
- DMS (Document management system)
- Empower2 and Empower 3
- Chromaleon
- UV probe
- Tiamo
Education
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)
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