RamyaKrishna P
Bitragunta
Summary
Dynamic Quality Assurance professional with extensive experience at APL Healthcare Pvt Ltd, specializing in process validation and batch record review. Proficient in Process Pad software and LIMS, Quality metrics Stream. Known for analytical skills and effective cross-departmental collaboration to enhance compliance and efficiency.
Overview
7
7
years of professional experience
Work History
Quality Assurance
APL Healthcare Pvt Ltd
Naidupet
06.2022 - Current
- Company Overview: USFDA approved
- Responsible for preparing, reviewing process validation (Stage 1, stage 2 and stage 3)
- Hold time protocols & compiling reports and data acquisition from LIMS
- Responsible for transport validation activities and freeze-thaw study activities.
- Responsible for preparing and reviewing packaging validation.
- Responsible for handling the Continued Process Verification Program (Stage 3 Process Validation) through Process Pad software.
- Responsible for coordinating with other departments for supporting validation
- Responsible for reviewing quality management system activities like change controls, deviations and CAPA’s
- Responsible for incorporating validation recommendations in batch records
- Responsible for training of protocols to concern personnel
- Responsible for collecting process validation, cleaning validation & hold samples as per protocols
- Responsible for verifying calibration of in process instruments
- Responsible for performing in process checks as per Batch manufacturing records, Batch packaging records
- Responsible for sampling of in process & finished products
- Responsible for assisting regulatory department for submitting validation related documents
- Responsible for online entries and reviewing BMRs.
- Responsible for reviewing data logger data of intermediate areas.
- Responsible for reviewing log books for data integrity.
- Responsible for performing AQL checks
- Responsible for implementing Kaizen’s (Continuous improvement)
- Perform GAP Analysis of different SOP’s
- Handling of Incidents and PNCs.
Quality Assurance Executive
STERILE-GENE LIFE SCIENCES
Bangalore
11.2019 - 08.2022
- Company Overview: WHO and MHRA approved.
- Reviewing of executed batch records.
- To ensure batch release documents Deviations and COA,
Quality Assurance Chemist
INTERMED LABORATORIES
Bangalore
06.2018 - 11.2019
- Company Overview: MHRA and TGA approved
- IPQA activites like line clearance and sampling
Education
Master of Pharmacy - Pharmacology
Sri Venkateswara University
Tirupati01.2019
Bachelor of Pharmacy -
RATNAM INSTITUTE OF PHARMACY
Nellore01.2017
Skills
- Process validation
- Batch record review
- Quality Metric System
- Process Pad software
- ERP
- LIMS
- Agile
- Ms office
Academic Activities
- Participated in National Conference held in S V U College of Pharmaceutical Sciences, S. V. University, Tirupathi.
- Attended and participated in a workshop on hands on training in analytical instrumentation organized by RATNAM INSTITUTE OF PHARMACY in association with KP labs, Kothapet, Hyderabad.
- Industrial training at Dr. Harry Life Sciences Pvt, Ltd.
Languages
Telugu
First Language
English
Proficient (C2)
C2
Tamil
Proficient (C2)
C2
Hindi
Upper Intermediate (B2)
B2
Personal Information
- Date of Birth: 01/17/96
- Gender: Female
- Nationality: Indian
Projects
Evaluation of Nephro protective potential of hydro alcoholic extract of Alpinia galangal leaves used in experimental animals. Formulation and evaluation of extended release solid dispersion of Rosuvastatin.
Disclaimer
I P. Ramya Krishna, do hereby declare that the above-mentioned information is correct up to my knowledge and I bear the responsibility for the correctness of the above-mentioned.
Timeline
Quality Assurance
APL Healthcare Pvt Ltd
06.2022 - Current
Quality Assurance Executive
STERILE-GENE LIFE SCIENCES
11.2019 - 08.2022
Quality Assurance Chemist
INTERMED LABORATORIES
06.2018 - 11.2019
Master of Pharmacy - Pharmacology
Sri Venkateswara University
Bachelor of Pharmacy -
RATNAM INSTITUTE OF PHARMACY
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