Obulesu Sirasani
Bangalore
Summary
Interested to work with a company to utilize my optimum caliber and knowledge gained from the experience for mutual benefits.
Experienced leader with strong background in guiding teams, managing complex projects, and achieving strategic objectives. Excels in developing efficient processes, ensuring high standards, and aligning efforts with organizational goals. Known for collaborative approach and commitment to excellence.
Overview
18
18
years of professional experience
1
1
Language
Work History
Team Leader
A Mylan Company (Converted from Strides Arco Labs - Oncology division)
06.2009 - Current
- Current Responsibilities:
- In-charge of GLP section.
- Accountability for the overall QC activities and compliance.
- Planning of daily work allocation to the analysts and execution
- Review for the daily verification activities i.e., pH, conductivity, analytical balances, temperatures monitoring and ICDAS audit trails
- Involve in preventive maintenance activities for the instruments
- Involve in periodic calibration activities for the instruments
- Involve in ICDAS alarm challenge verification activities for Cooling chambers, Deep freezer and Ultra deep freezer
- Involve in new instrument qualification i.e., IQ/OQ/PQ
- Review for Empower projects audit trails
- Involve in new instrument method creation for Empower application
- Involve in LACE rebooting for Empower application
- Involve in Creation new purchase requisition
- Involve instrument AMC and CMC activities
- Review for monthly log book review planner
- Involve in GLP (Good Laboratories Practices) activities
- Involve in material and product sent for outside testing procedure
- Preparation and approval for GxP periodic review for computerized systems
- Review for monthly audit trail for standalone computerized systems
- Involve in issuance for standard vials in LIMS, logging to new standards, standards review in LIMS and destroyed.
- Involve in new column logging in LIMS, review and approval process activities and destruction of columns
- Involve in new working standard preparation, review, approval and re-validation process
- Involve in Scheduled data archival process activities
- Involve in data restoration and CSV activities
- Involve in ACPM (Access control password management) preparation and approval process
- Involve in service engineer coordination for calibration and qualification activities
- Handling of Change control, task, CAPA, Effectiveness check, OOS, OOT and incidents.
- Review and releasing of stability reports and compilation without delay.
- Review and releasing of finished product and in-process without delay.
- Involve in reserve sample receive and storage procedure
- Preparing and execution of stability protocols.
- Guiding to the juniors in IP aspects, monitoring their progress and audit compliance.
- Conducting training to the analysts and qualifying them for routine lab activities.
- Manufacturing of Injectable, Lyophilized products
- Regulatory approvals: USFDA, MHRA, MCC, TGA, Health Canada, PMDA and ANVISA
- Total experience: About 16 years
Quality Control – Senior Chemist
Cheminnova Pharmaceuticals
12.2007 - 02.2009
- Responsibilities
- GLP complies, online monitoring and review with in timeline
- Involve in instrument management, working standards qualification, preventive maintenance activities, calibration and qualifications
- Involve in in process, finished products and stability samples.
- Manufacturing of tablets, syrups
Education
MSC. - Chemistry
S.K. University
01-2006
BSC. - undefined
S.K.S.C Degree College
01-2003
Skills
Strong working knowledge in review of documents
Good interpersonal and communication skills
Excellent and ability to demonstrate sound judgment
Managing skills and ability to handle multiple tasks
Attention to detail, team player, problem solving
Good knowledge on instrument management handling & Semi finished goods
Strong working knowledge in analysis and troubleshooting
Good audit skills and report preparation
Knowledge on GLP, QMS & Regulatory requirements
Good instrument management skills and investigation skills
Good working knowledge on software handling in pharmaceutical requirements
Interests
Reading books, Internet, watching TV, watching cricket and spending with family
Affirmation
I hereby declare that all the information furnished above are true and correct to the best of my Knowledge and belief.
Types of Instruments handled
- HPLC (Empower-3, FR5), GC (Empower-3, FR5), Shimadzu (LC Solution), Agilent 1100, 1200 and 1260 (RI Detector, chemstation), Dionex (Chromeleon), Jasco HPLC and GC G1888 &7890
- IR spectrum IR ES, Polarimeter, Particle size analyzer (Zetasizer, Malvern)
- Polarimeter, melting point, TOC, Particulate matter, UV, pH meter, conductivity meter, Auto Titrators, KF Titrators, KF Coulometer, Refractometer, analytical and micro weighing balances
- Distex Dissolution apparatus, Cooling chambers, Deep freezer and Ultra deep freezer
- Isolator, Osmometer.
QMS Software handled
- LIMS, Documentum, Smart source, CARA, ICDAS and Track wise
- LIMS preparation of analysis and new product creation
Major Regulatory Audits Faced
- USFDA
- ANVISA
- MHRA
- TGA
Timeline
Team Leader
A Mylan Company (Converted from Strides Arco Labs - Oncology division)
06.2009 - Current
Quality Control – Senior Chemist
Cheminnova Pharmaceuticals
12.2007 - 02.2009
BSC. - undefined
S.K.S.C Degree College
MSC. - Chemistry
S.K. University