S DINESHKUMAR

To work in an organization where I can apply my knowledge and learn the latest technology with the team of experienced professionals. Dedicated professional skillful in sample collection, data recording and instrument calibration. Resourceful and adaptable individual with extensive experience developing and conducting experiments to document results for studies. Comfortable handling complex issues, meeting strict deadlines and adjusting to rapidly changing conditions. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.

Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.

• Father's Name: Subramanian .S
• Date of Birth: 12/01/1999

• Good Documentation Practices as per cGMP
• Sample analyse as per Standard Operating Procedure (SOP), General Testing Procedure (GTP) for USP monograph
• Sampling activity for all raw material and packing materials and finished products
• Microbiological Analysis
• Media preparation and sterilization activity
• Environmental monitoring at production area, packing area, storage area
• Bio-ball and Positive culture maintenance
• Finished product microbial enumeration test
• Performed microbial limit test for routine water samples (WFI, Pure steam condensate, purified water, feed /source water)
• Performed microbiological analysis of Bio-inactivated water
• Performed verification and calibration of weighing balance and micropipettes
• Total Aerobic Microbial Count(TAMC) and Specific pathogens test in water
• Bacterial Endotoxin Test (BET) by gel clot method
• Total Organic Carbon(TOC) analyzes
• Performed microbial seed characterization of C. diphtheria., Clostridium tetani., Bordetella pertussis
• Media stock maintenance and Growth Promotion, Inhibition Test(GPT) for media
• Sterility test and bioburden for the intermediate and final samples
• Involved in identification of sterility failure
• Staining technique –Gram staining
• Isolation and Identification of bacterial colonies by biochemical testing
• Retention sample Maintenance of all raw materials and finished products
• Microbial analysis for stability sample
• Routine observation of environmental monitoring plates, water analysis plates, miscellaneous samples
• Daily monitoring of Differential pressure& Relative humidity for Classified areas and Preparation of disinfectant
• Perform the investigations for deviations/Incidents to find out the root cause and ensuring effective implementation of corrective and Preventive action
• Responsible for review the calibration record for instruments/equipment’s in a timely manner and maintain records
• Ensure all works practices comply with the written SOPs, documentation (Record Log Sheets/Books) follows up co-ordination with QA
• Audit Faced
• Food and Drug Administration (FDA)
• Dietary supplement verification by USP
• British Retail Consortium (BRC)
• Internal audits
• Equipment, Instruments handling & Calibration
• Analytical weighing balance & dispensing booth
• Hot Air Oven
• Cooling centrifuge
• Autoclave (Single & Double door)
• UV-Spectrophotometer
• Bio Safety Cabinet
• PH meter
• Dry Heat Sterilizer
• Walk in Incubators
• TOC analyzer
• Dry Heat Block
• Sentino pump
• Temperature & Humidity meter

Audit Faced

o Food and Drug Administration (FDA).

o Dietary supplement verification by USP.

o British Retail Consortium (BRC).

o Internal audits.

o Analytical weighing balance & dispensing booth

o Hot Air Oven

o Cooling centrifuge

o Autoclave (Single & Double door)

o UV-Spectrophotometer

o Bio Safety Cabinet

o PH meter

o Dry Heat Sterilizer

o Walk in Incubators

o TOC analyzer

o Dry Heat Block

o Sentino pump

o Temperature & Humidity meter