RESUME

G.SRI SAI RAGHAVENDRA SRI HARSHA

H. No: 8-323, Ram Nagar, Mail Id: harsharaghavendra12@gmail.com
Sai Raghavendra Sri Nilayam, Phone No:+916301684836
Vijayawada Road,
Hanuman Junction,
Krishna-521105

Professional Objective:

 To pursue a challenging career and be a part of a progressive organization that gives scope to
enhance to support enterprises with my service my knowledge, skills with sheer determination,
dedication and hard work.

Educational Qualification: -

 M. Pharmacy (Pharmaceutical Analysis and Quality assurance) from Sir C.R.R. College of
Pharmacy, Eluru Affiliated to Andhra University, A.P, 2019 with 7.6 CGPA.
 B. Pharmacy from GIET School of Pharmaceutical Sciences of Andhra University, 2016 with
5.9 CGPA.
 Intermediate (10+2) from Narayana Junior College, affiliated to Board of Intermediate, A.P,
2012 with 82%.
 SSC from Sai Geethanjali High School affiliated to State Board of Secondary Education, 2010
with 89%.

Work Experience: -
 Worked as junior executive in Quality Assurance at Daicel ChiralTechnologies
(India) Private Limited from June-2020 to October-2022.
 Worked as Trainee (Quality Assurance) at Laurus Labs Pvt. Limited- Unit-2 from Aug 2019
to Dec-2019.

Professional summary: -
Key Responsibilities as Junior Executive – Quality Assurance (Daicel): -
 Review of Analytical Method Development and Validation Protocols, Raw data & Reports
(HPLC/GCHS/GCMS/MS, LCMS/MS, ICPMS, IC/UV/MICROPLATE READER, SEC,
Circular Dichroism & In Vitro Dialysis System etc.)
 Review of Extractable and Leachable study Protocol’s Data and Report.
 Review and approve of review of Calibration data.
 Review of Biologics Data i.e., Bio-Assay and Bio-Identity Study Protocol’s/Data/Report’s.
 Handled the Bio-Assay department also Ensured the Lab Compliance and QMS Issues.
 Issuance and Review of all applicable logbooks, forms and formats.
 Review of Changes through Change Control and evaluation of changes with impact assessment
from quality and regulatory assessment.
 Assisting quality manger in facing regulatory audits/ Inspections/ Customer audits.
 Participate in investigations to identify the root cause, assessment of impact of incidents,
deviations, and to ensure timely closure for quality and regulatory compliance. Evaluation of
effectiveness of CAPA.
  Conduct Internal quality audits Periodically.
 Providing Quality System Orientation Trainings to new employees and also providing the
Training to the New Joiners on Quality Management System, QA procedure, applicable
standards and guidelines.
 Review of calibration reports (HPLC, UV, GC-MS/MS,GC-HS/IC/ICP-MS/Micro ,Semi Micro
Balances and Dissolution Apparatus etc.).
 Review of Method Verification and Method Validations protocols and reports.
 Review of Method Development and Batch Analysis Reports with the inline Timelines.
 Daily Monitoring Data, and also Verifying the Online Documentation related to LNB and
Equipment Logbooks.
 Review of Data related to Cell-Free-Assay and Cell-Based Assay.
 Handling of Equipment/Instrument Qualifications along with the Quality Assurance Team and
Analytical Team.
 Maintenance of Archive’s and ensuring the file Numbering/Labelling as well as
submission/retrieval during the Customer Audits.
 Indent of Equipment Logbooks/Laboratory Note Books from the 3rd Party Vendor and took the
Continuous Follow-Up until the time of Delivery.
Key Responsibilities as Trainee – Quality Assurance (Laurus Labs Pvt Limited.Unit-2): -
 Review of IPQA Related Data from Ware House to Secondary Packing.
 Review of BMR/BPR Records of Various Release Testing Batches.
 Ensure the Process Related to IPQA and Packing.
 Review of Training Files of the Employees and Allotment of Training Schedules to the New
joiners.

Quality Management System: -

 Monitoring of Quality Management system activities
 Preparation & Review of SOP’s.
 Handling of Change Controls & Deviations
 Breakdowns of Instruments/Equipment’s.

Achievements: -
 Contributed for unannounced USFDA audit held in Nov 2020 at Laurus Labs private limited.
 Participated in major customer audits like ISO 9001:2015, Sionc Pharm, ACE Bright,
Slayback, LM Manufacturing, Inventia, Amneal, Mehta, Biocon.
 Recognized as best employee in Quality Assurance several times by the management of Daicel
Chiral Technologies (India) Private Limited.
 Taken the Additional Responsibility of Lab Compliance for the Microbiology Department as
instructed by the Quality Senior Manager.
 Successfully achieved TAT and contributed in the timely delivery of Biologics projects to
customers.

Positive Traits: -
 Zeal to learn new things for academic growth.
 Hardworking and willing to take on new responsibilities and responds to it with good initiative.
 Responsible and dedicated, can be relied on to deliver job require.
 Quality work with handling of multi tasks.
 Positive Thinking & Leadership Skills.
Personal Profile
 Name : G. SRI SAI RAGHAVENDRA SRI HARSHA
 Father's name : SRINIVASA SARMA.GINJUPALLI
 Date of birth : 05-Aug-1995
 Marital Status : Unmarried
 Sex : Male
 Nationality : Indian
 Languages Known : English, Telugu and Hindi

Declaration: -
I hereby declare that the above-furnished information is true to the best of my knowledge.

Yours Sincerely,
Ginjupalli. Sri Sai Raghavendra Sri Harsha

Date:
Place: - Hanuman Junction