Vijayakumar R
Visakhapatnam
Summary
Quality Control professional with over 14 years of experience in analytical operations in the pharmaceutical sector. Proven expertise in quality control for sterile injectables, non-sterile products, and oral solid dosage forms. Experienced in managing Empower audit trails, conducting critical investigations, and ensuring regulatory compliance through effective documentation. Committed to operational excellence and maintaining high product quality standards.
Overview
15
15
years of professional experience
Work History
Assistant Manager
Laurus Lab Limited
Visakhapatnam
09.2015 - Current
- Planned and managed daily quality control operations, and led a team of 20 members.
- Reviewed Empower audit trails and reports to uphold data integrity and regulatory compliance
- Harmonized quality control testing procedures and standard operating procedures.
- Reviewed and enhanced OOS, OOT, laboratory incidents, and deviations documentation.
- Participated in regulatory audits and major customer inspections, such as USFDA (multiple times), WHO, ANVISA, and customer audits, etc.
- Conducted training sessions on STPs, SOPs, investigation reports, and regulatory guidelines.
- Reviewed method transfer and verification activities to ensure compliance with testing standards.
- Prepared and evaluated protocols and reports for accuracy and completeness.
- Trained staff on instrumental SOPs and system procedures to improve operational efficiency.
- Resolved technical issues for HPLC and GC instruments to maintain optimal lab performance.
Officer
Neuland Laboratories Ltd
Hyderabad
06.2014 - 05.2015
- Performed routine and non-routine analyses on raw materials, reference materials, and drug substances using a variety of instruments, like HPLC and GC.
- Troubleshooting instruments like HPLC and GC.
- Review and release of samples, such as raw materials, intermediates, and finished products.
- Involved in the investigation of OOS, OOT, and closing with effective CAPA.
- Prepared the certification of analysis and the analytical test report.
- Operation and calibration of instruments like HPLC and GC.
Chemist
Aurobindo Pharma Limited
Hyderabad
06.2010 - 05.2014
- Examined raw materials, in-process intermediates, and sterile finished products (for injections) using instruments like HPLC, GC, pH, KF titrator, MR meter, UV, etc.
- Qualification and maintenance of laboratory standards for APIs, intermediates, raw materials, and their impurities.
- Preparation of specifications, method of analysis, and certificate of analysis for raw materials, intermediates, and finished products.
- Operation and calibration of quality control laboratory instruments.
- Performed the validated Excel sheets.
Education
Master of Science - Chemistry
Sabarmati University
Ahmadabad06-2012
Bachelor of Science - Chemistry
Sri Venkateswara University
Tirupati 06-2010
Skills
- Teamwork
- Time management
- Quality control
- Strategic planning
- Problem-solving aptitude
- Leadership
- Laboratory investigations
- Self motivation
- Employee training
- Cross-functional team leadership
Instruments Handled HPLC Model:
Waters 2695 and Water Arc systems, and detectors like UV, PDA, and RI
Agilent 1100 and 1200 Infinity II
Shimadzu 2030C, 2030CP, 2050C I prominence
Software’s:
LC Solutions
Empower-2, Empower-3, and Empower-3.6.1
ChemStation, EZ Chrome, and Open Lab software.
Personal details:
Date of birth: July 30, 1987
Gender: Male
Languages known: Telugu, English, Tamil, and Hindi
Permanent Address: Flat No. 303, Simhadri Plaza, Shirdi Sai Nagar, Visakhapatnam 530053
Phone No: 9642998789
Timeline
Assistant Manager
Laurus Lab Limited
09.2015 - Current
Officer
Neuland Laboratories Ltd
06.2014 - 05.2015
Chemist
Aurobindo Pharma Limited
06.2010 - 05.2014
Master of Science - Chemistry
Sabarmati University
Bachelor of Science - Chemistry
Sri Venkateswara University
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