Prakash Ravula
Specialist
Guntur,AP
Summary
Results-driven Quality Assurance and Quality Control professional with 12 years 9 months of experience in MAH. Expertise in navigating consent decree environments with a focus on compliance and operational productivity. Demonstrates strong leadership and effective communication skills to enhance quality and safety outcomes.
Overview
4
4
Languages
13
13
years of professional experience
Work History
Market Authorization Holder. (GQSI)
Sandoz Pvt Ltd
09.2024 - Current
- Led Market Authorization Holder responsibilities to ensure compliance with global regulatory requirements, safeguarding product integrity.
- Led coordination with SCQ & SPOCs and facilitated monthly governance calls, collaborating with manufacturing, packaging, testing, and batch release sites as on when required, to prepare and maintain the MAH reviews within timelines.
- Compiled MAH review by extracting data from multiple sources and standardizing outputs into predefined formats, enhancing clarity and consistency.
- Compiled MAH review by extracting data from multiple sources and standardizing outputs into predefined formats.
AQA
Intas Pharma
08.2023 - 08.2024
- Reviewed analytical data (in-process, finished products, stability, process validation) to ensure ALCOA++ compliance and integrity of results.
- Conducted electronic audit trail reviews of laboratory data to verify accuracy and completeness.
- Investigated OOS, OOT, and incident documents via Qedge QMS to identify root causes and implement corrective actions.
- Ensured complete adherence to GxP compliance.
AQA. Dept
Aurobindo Healthcare Ltd, Unit-4
12.2019 - 08.2023
- Reviewed analytical data for in-process, finished products, and stability studies to ensure ALCOA++ compliance, supporting quality assurance processes.
- Investigated and resolved OOS, OOT, and PNC documents, ensuring clear documentation for auditor transparency.
- Coordinated internal audits and facilitated regulatory inspections (USFDA), enhancing compliance readiness.
- Supported audit processes by ensuring timely delivery of documents to auditors during audits and shared knowledge across functional teams.
Commercial Stability
Apotex Research Pvt Ltd
03.2016 - 11.2019
- Executed method verification (MV) and TAP analysis following established protocols for Canada and Australia markets.
- Analyzed protocols, data, and reports for MV and TAP projects to ensure accuracy and adherence to standards.
- Facilitated QMS investigations by evaluating OOS and OOT incidents through diagnostic and hypothesis assessments.
Centralized Stability Lab
Medreich Ltd
09.2014 - 02.2016
- Conducted method verification and stability sample analysis to ensure compliance with regulatory standards.
- Performed calibration of HPLC, dissolution, and UV spectrophotometer to maintain equipment accuracy and reliability.
- Analyzed stability samples for various dosage forms (tablets, capsules, syrups, injectables) to support product development and quality assurance.
QC Stability Lab
Medopharm Ltd
04.2013 - 05.2014
- Analyzed stability samples and finished products according to STPs and protocols.
- Self-motivated, with a strong sense of personal responsibility.
- Worked effectively in fast-paced environments.
- Skilled at working independently and collaboratively in a team environment.
Education
Masters - Pharmaceutical Analysis and Quality Assurance
GIET School of Pharmacy
Rajamahendravaram, A.P11-2012
Skills
Market authorization
Cross-functional leadership
Data reporting
Audit support
Pharmaceutical Regulations
Quality management systems
Analytical testing
HPLC proficiency
Timeline
Market Authorization Holder. (GQSI)
Sandoz Pvt Ltd
09.2024 - Current
AQA
Intas Pharma
08.2023 - 08.2024
AQA. Dept
Aurobindo Healthcare Ltd, Unit-4
12.2019 - 08.2023
Commercial Stability
Apotex Research Pvt Ltd
03.2016 - 11.2019
Centralized Stability Lab
Medreich Ltd
09.2014 - 02.2016
QC Stability Lab
Medopharm Ltd
04.2013 - 05.2014
Masters - Pharmaceutical Analysis and Quality Assurance
GIET School of Pharmacy
Declaration
I hereby declare that the information furnished above is true to the best of my knowledge. Date: 2026-06-02 Place: Hyderabad Signature: Ravula Prakash
Personal Profile
- Father’s Name: R. Srinivas Rao
- Mother’s Name: R. Padmavathi
- Marital Status: Married
- Spouse’s Name: T. Deepika (Advocate)
- Date of Birth: 1989-07-31
- Nationality: Indian
- Address: H.No. 8-21-18/1, Seetha Ram Nagar, 3rd Lane, Guntur-1, Andhra Pradesh, India