Kishor S S
Senior Executive-Quality Control
Bangalore
Summary
Driven Senior Executive with a proven track record at Biocon Biologics Ltd, showcasing expertise in GLP and ALCOA+ principles. Demonstrated leadership in streamlining processes for efficiency and accuracy, enhancing data integrity and compliance. Excelled in troubleshooting and adapting to fast-paced environments, with a commitment to meticulous documentation and effective communication. High-achieving senior executive bringing expertise in business planning, revenue development and change management. Offers 8+ years of leadership in Pharama industry along with entrepreneurial, forward-thinking mindset and demonstrated track record of accomplishment.
Overview
9
9
years of professional experience
Work History
Senior Executive
Biocon Biologics Ltd
02.2022 - Current
- Adherence to cGMP (Current Good Manufacturing Practice) and cGLP (Current Good Laboratory Practice).
- Adherence to product specifications.
- Receipt of samples for testing and generation of Analytical Reference number and storage of sample at proper storage condition,samples tracking ,allotment and discarding of samples.
- In process, Finished product and Stability samples testing for different products.
- Daily Checking, updating of status boards online completion of all instrument’s logbooks, Specifications and other documents for its review, and reporting to concerned person.
- Hands on experience on estimation of IgG by Protein A-Affinity, SEC, IEX, CIEX,Sarkosyl estimation and protein estimation by RP-HPLC techniques.
- Use of Agilent HPLC systems with VWD/CAD/PDA detections and Waters EMPOWER 3 data acquisition.
- Issue and review of raw data book/ Checklists/ log sheets for record entries.
- Samples will received through SAP system. Once the QC analysis has been conducted, result will updated through SAP system to production.
- Performing daily calibration of pH meter and weighing balance, and also to ensure HPLC, UV- visible spectrophotometer and Osmometer are calibrated within the due date.
Executive
Strides Pharma Science KRSG
12.2015 - 01.2022
- Responsible for the analysis of sample by referring current version of specification /STP with relevant material code.
- Ensuring the sample integrity with respect to labeling, container, packing, etc..along with availability of working standard/ impurities/ reagent/ chemical/ column are as per STP and within the validity.
- Responsible for initial setup on GC and column stabilization as per the STP with relevant online entries in usage log/LMS.
- Creation and ensure the standard set by using proper programs/ QNT as per STP, upon confirmation on initial system suitability and samples loading into chromatograph.
- Preserving all standard /sample solution till completion of the review. Responsible for checking all results in LIMS and reporting of any observed results that do not meet the requirement [OOS/OOT/Deviation], to the Team Leader or Head QC for further investigation.
- Execution of electronic signature of the data in PDF to review after completion of the analysis
Education
Master of Science - General Chemistry
Shiva Gangothri University
Davangere, India 04.2001 -
Skills
ALCOA
LIMS
GLP
Osmometer
Good documentation practices
Diligent and time bound
Self motivated and prompt
Process oriented
Leadership
Excellent written and verbal communication skills
21 CFR
Adaptable and flexible
Troubleshooting skills
Data integrity
Timeline
Senior Executive
Biocon Biologics Ltd
02.2022 - Current
Executive
Strides Pharma Science KRSG
12.2015 - 01.2022
Master of Science - General Chemistry
Shiva Gangothri University
04.2001 -