Track wise
DURGA SRINIVAS D
IPQA STERILE INJECTABLES
Summary
Dynamic Sr. Executive with extensive experience at Cronus Pharma Specialties Pvt Ltd, specializing in manufacturing compliance and batch release activities. Proven track record in APQR preparation and QMS support, coupled with strong training abilities. Adept at ensuring data integrity and GMP adherence, driving operational excellence in sterile injectables.
Overview
11
11
years of professional experience
2
2
Languages
Work History
Sr.Executive
Cronus Pharma Specialties Pvt Ltd
12.2024 - Current
- oversee manufacturing compliance in sterile injectables.
- Perform timely inprocess checks during vial washing ,filling and sealing activity.
- Ensure line clearance for RM/PM dispensing,vial washing,compounding and filling activities.
- Ensure GDP and data compliance in BMR by thorough reviewing of process reports,filter integrity and glove integrity reports etc.
- APQR preparation
- Medial Fill protocol and summary report preparation .
- Process validation protocol and summary report preparation.
- Initiate change control and deviation in Trackwise software if needed .
- Preparation of Quality risk assessments based on requirement.
- Supporting to QMS team in investigation procedures during deviation and market complaints.
- To give training to the new joiners on GMP and data compliance in manufacturing activities.
- Perform AQL after finishing of visual inspection process.
- Batch release activities.
- Verification of elog on daily basis.
Executive
Natco Pharma Limited
01.2022 - 09.2024
- Ensure Manufacturing compliance in sterile oncology products along with dry powders.
- Ensure timely inprocess checks during vial washing,tunnel and filling activities.
- Ensure GMP and GDP during compounding process by adhering strictly to the SOP's .
- Ensure GDP and GMP compliance by thorough review of process reports,alarm events and system audit trails.
- Batch release activities.
- Preparation of Mediafill and PV reports
- Training to new joiners on GDP and GMP compliance during manufacturing activities.
- To conduct Visual inspector qualifications.
- To Perform AQL on inspected containers .
- To authorize destruction of expired materials .
- verification of log books on daily basis.
Jr.Executive
Eugia Pharma
12.2017 - 12.2021
- Ensure timely inprocess checks during vial labeling,carton coding and shipper packing activities.
- Conduct Visual inspector qualifications.
- To perform AQL on inspected good containers .
- Ensure Data compliance and GMP during packing activities.
- BPCR reviews.
Chemist
Gland Pharma Ltd
12.2013 - 12.2017
- Ensure timely inprocess checks during vial labeling,carton coding and shipper packing activities.
- Conduct Visual inspector qualifications.
- To perform AQL on inspected good containers .
- Ensure Data compliance and GMP during packing activities.
- BPCR reviews.
Education
Master of Science - Pharmaceutical Sciences
A.M.REDDY COLLEGE OF PHARMACY
Narasaraopet, India 04.2001 -
Bachelor of Science - Pharmaceutical Sciences
A.M.REEDYT COLLEGE OF PHARMACY
Narasaraopet, India 04.2001 -
High School Diploma -
Krishnaveni Junior College
Narasaraopet, India 04.2001 -
S.S.C - Science,Biology,English And Social Studies
Swami High School
Narasaraopet, India 04.2001 -
Skills
APQR
Manufacturing complaince
Batch Release activties
QMS support
Software
MS word
MS excel and power point presentations
Interests
Motor rides
Timeline
Sr.Executive
Cronus Pharma Specialties Pvt Ltd
12.2024 - Current
Executive
Natco Pharma Limited
01.2022 - 09.2024
Jr.Executive
Eugia Pharma
12.2017 - 12.2021
Chemist
Gland Pharma Ltd
12.2013 - 12.2017
Master of Science - Pharmaceutical Sciences
A.M.REDDY COLLEGE OF PHARMACY
04.2001 -
Bachelor of Science - Pharmaceutical Sciences
A.M.REEDYT COLLEGE OF PHARMACY
04.2001 -
High School Diploma -
Krishnaveni Junior College
04.2001 -
S.S.C - Science,Biology,English And Social Studies
Swami High School
04.2001 -
Similar Profiles
P. SANJEEVI GIRI BABUP. SANJEEVI GIRI BABU
Manager at Cronus Pharma Specialties LtdManager at Cronus Pharma Specialties Ltd
FATHE MOHAMMAD SHAIKFATHE MOHAMMAD SHAIK
Asst. Manager at CRONUS PHARMA PVT LTDAsst. Manager at CRONUS PHARMA PVT LTD
DUVVADA HARSHAVARDHANDUVVADA HARSHAVARDHAN
Trainee: Information Systems at Eugia Pharma Specialties LimitedTrainee: Information Systems at Eugia Pharma Specialties Limited
MITHUN ASHARMITHUN ASHAR
SR.EXECUTIVE at CREDIT FARESR.EXECUTIVE at CREDIT FARE
PRIYA GUHAPRIYA GUHA
Sr.Executive at HelpAge IndiaSr.Executive at HelpAge India