Summary
Overview
Work History
Education
Skills
Languages
Disclaimer
Personal Information
Personal Skills And Achievements
Timeline
Generic

Venkata Ram Durga Nagesh Nekkanti

Hyderabad

Summary

Dynamic Sr. Executive with extensive experience at Aurobindo Pharma Ltd, excelling in In-process Quality Assurance and training coordination. Proficient in HPLC and ERP, I ensure compliance with cGMP standards while fostering a culture of continuous improvement. Adept at managing audits and driving quality initiatives, I am committed to operational excellence.

Overview

10
10
years of professional experience

Work History

Sr.Executive

Aurobindo Pharma Ltd
02.2016 - Current
  • Primarily responsible for carrying out all In-process Quality Assurance activities in Production Block, which include:
  • 1. Ensuring that all personnel involved in manufacturing activities execute their job according to cGMP requirements and the respective Standard Operating Procedures.
  • 2. Carrying out in-process checks as per the frequency mentioned in the Standard Operating Procedures/Batch Records.
  • 3. Line clearances before the start of any new activity.
  • 4. Ensuring that proper environmental conditions are maintained during manufacturing operations.
  • 5. Ensuring that all log sheets and records are updated online with the operation.
  • 6. Ensuring that preventive maintenance activities are carried out as per schedule and records are maintained.
  • 7. Reporting of deviations and non-conformances.
  • 8. To ensure compliance to quality systems during manufacturing operations.
  • 9. To ensure on line document of batch processing activities.
  • 10. Dispensing of raw materials and packing materials.
  • 11. Execute validation activities as per schedule.
  • 12. Review of draft batch processing and packaging records, that are to be manufactured in respective area Review and approval of batch processing records after completion of each stages. Responsible for getting approval of batch processing records by quality assurance department head after his review.
  • 13. Sampling of In process and Finished product.
  • 14. Review of executed BPRRs and BPARs.
  • 15. To post the samples in ERP and ensure the completion of the batch.
  • 16. Calibration of in process instruments, friabilator, Hardness tester, Disintegration test apparatus, IR Moisture analyzer etc.
  • 17. Execution of process validation protocol and to collect as samples as per the protocol.
  • 18. To follow and implement Environment Management System related procedures.
  • 19. Ensure compliance with Aurobindo’s Quality Culture Program, Quality Policy and related Global Procedures.
  • Additionally, Responsible for co-ordination of all training activities in the plant which include:
  • 1. Coordinate with Section/Department In charge for Identification of Training Needs for employees.
  • 2. Initiating job responsibilities and co-ordination of their training activities of New joinees after consultation with concerned Section/Department In charge.
  • 3. Updating of Employee Master List, Organogram, Specimen Signature log.
  • 4. Initiation/Modification of Job Responsibility of employees.
  • 5. To coordinate with All Department Heads and completion of the long-term & short term evaluation of all employees as per schedule.
  • 6. To coordinate with CQA Training co-ordinator for any external Training related activities.
  • 7. To Review and up grade SOP's wherever required for continuous improvement.
  • 8. To co-ordinate for cGMP/ cGDP related training to all Employees.
  • 9. Responsible for co-ordination of trainings on all CAPA’s/ PNC’s and Market Complaints generated CAPA’s to all the concerned personnels.
  • 10. To ensure co-ordination for trainings of Contract workmen.
  • 11. Preparation of Annual refresher training schedule.
  • 12. Maintaining Employee Training File.
  • 13. Responsible for QMS (Quality Management System activities i.e. Change control, PNC, DMS and CAPA etc) with respect to Training.

Executive

Biocon-India Limited
Bangalore
01.2015 - 02.2016
  • Responsibilities:
  • Stability Analysis
  • Standard Qualification and Impurity Standard Qualification
  • Requalification of Standards
  • Calibrations
  • Validation
  • AUDIT EXPOSURE: Exposure to the various regulatory audits like USFDA, PMDA, MHRA

Education

M.Pharmacy - Pharmaceutics

S.Chavaan college of pharmacy
Nellore
01.2013

B.Pharmacy -

Sri Rama Chandra College of Pharmacy
Chennai
01.2011

Skills

  • IRIS
  • Trackwise
  • OPAL
  • ERP
  • HPLC
  • GC
  • Shimadzu HPLC
  • UV

Languages

  • English
  • Hindi
  • Telugu
  • Tamil

Disclaimer

I hereby declare that the information furnished above is true to the best of my knowledge.

Personal Information

Date of Birth: 06/06/89

Personal Skills And Achievements

IRIS (Application status and submission tracking system), Trackwise (for change controls), OPAL (submission tracking system), ERP (Enterprise resource planning), HPLC, GC, Shimadzu HPLC, UV, Dissolution Apparatus, humidity chamber, Uttam Vyavahar Award, Talent of the month award in Aurobindo

Timeline

Sr.Executive

Aurobindo Pharma Ltd
02.2016 - Current

Executive

Biocon-India Limited
01.2015 - 02.2016

M.Pharmacy - Pharmaceutics

S.Chavaan college of pharmacy

B.Pharmacy -

Sri Rama Chandra College of Pharmacy
Venkata Ram Durga Nagesh Nekkanti