Devendra Kumar
Quality Assurance
Hyderabad
Summary
Intend to build a career with leading Pharmaceutical Company with committed & dedicated people, which will help me to explore myself fully and realize my potential. Dedicated Pharmaceutical professional with a history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.
Overview
15
15
years of professional experience
Work History
Dy. Manager (Quality Assurance)
M/s. Nasense Labs Private Limited
Jeedimetla
06.2023 - Current
- Responsible for the monitoring of QA activities, function and programs designed and developed
- Responsible to review of QMS related documents
- Responsible to organize the periodic QA checks of facilities, systems, Procedures and records of all departments to maintain quality of the products at all stages of manufacturing and testing
- Responsible for review of product releases.
Asst. Manager (Quality Assurance)
MSN Pharmachem Private Limited
Pashamylaram
07.2012 - 06.2023
- Responsible for Establishing and review of Customer quality agreement
- Handling of documents through LIMS and eDMS software’s
- Handling of product complaints and providing CAPA for the same
- Handling of Return goods and recalls
- Assist in Internal and External Quality Systems Audits and the CAPA implementation
- Handling of Vendor evaluation and qualification for starting materials and raw materials
- Preparation of Annual Product Review (APR)
- Logging and handling the investigations for deviations, OOS and providing CAPA for the same
- Review of completed production batch record and laboratory records before releasing API for distribution
- Responsible for review of Customer specification & methods
- Preparation, review and approval of Customer Questionnaires
- Handling of Change control management Co-ordinate with cross functional departments in addressing Regulatory deficiencies or Queries
- Responsible for Finished product and Intermediate Sampling & dispatch activities
- Responsible for training and qualification of personnel
- Responsible for applying Specific export, GMP and WC licence copies
- Responsible for Supporting Documentation work related to Internal Audits, Customer Audits and Regulatory requirements (USFDA, EMA, KFDA and ANVISA ).
Chemist (Quality Assurance)
Natco Pharma Limited
Mekaguda
05.2009 - 06.2012
- Preparation and Review of standard operating procedures (SOP’s) Preparation & review of the Annual Product Quality Review reports
- Review & approval of final product quality data and certificate of Analysis
- Preparation and Review of Process validation protocols & reports
- Preparation of Site Master File (SMF) & Validation Master File (VMP) as per guidelines
- Review of Batch Manufacturing Records (BMRs) & its Raw data sheets for the manufacture of API’s, Intermediates
- Daily Plant inspection for the implementation of GMPs
- Well versed in preparation of all types of documentation work related to all departments
- Responsible for Supporting to Internal Audits, Customer Audits and Regulatory requirements.
Education
Master of Science - Chemistry
Dr.B.R. Ambedkar Open University
Hyderabad 08.2023 - Current
Skills
Task delegation
Performance improvements
Process and procedure development
Quality assurance maintenance
Committed to quality assurance
Quality assurance support
Quality Assurance Management
Quality assurance inspections
Quality Assurance and Verification
Educational Profile
- Pursuing M.Sc (Chemistry) from Dr. B.R.Ambedkar University in Distance mode.
- B.Sc (Math’s, Physics, Chemistry) from S.V.V.K.P Arts & Science College.
- Intermediate (Math’s, Physics, Chemistry) from S.V.V.K.P Junior college.
Personal Skills And Strengths
- Able to work as a team leader to meet customer / organizational needs.
- Fast and dedicated learner.
- Commitment, dedication towards job until completion.
- Always prepared to face new challenges.
- Good Computer skills on documents preparation.
- Good typing speed (35wpm)
- Good knowledge on handling of LIMS and eDMS software’s.
Personal Information
- Date of Birth: 02/11/1985
- Marital Status: Married
Disclaimer
I hereby declare that the information provided above is correct to the best of my knowledge and belief.
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Master of Science - Chemistry
Dr.B.R. Ambedkar Open University
08.2023 - Current
Dy. Manager (Quality Assurance)
M/s. Nasense Labs Private Limited
06.2023 - Current
Asst. Manager (Quality Assurance)
MSN Pharmachem Private Limited
07.2012 - 06.2023
Chemist (Quality Assurance)
Natco Pharma Limited
05.2009 - 06.2012