Raghu Vamshi krishna Myneni
Hyderabad
Summary
Quality Assurance & QMS leader with over 15 years in biologics and pharmaceuticals. Specialises in designing and governing GMP-compliant Quality Management Systems and ensuring inspection readiness for regulatory agencies. Experienced in CAPA effectiveness, Quality Risk Management, and continuous improvement, with hands-on expertise in aseptic operations, clean utilities, and digital QMS tools.
Overview
16
16
years of professional experience
Work History
Sr. Manager – QA QMS (SME), QMS Lead
CuraTeQ Biologics Pvt. Ltd.
Hyderabad
09.2021 - Current
- Led internal and partner audits, ensuring data integrity and timely closure of corrective and preventive actions (CAPA).
- Oversaw governance and quality indicators, enabling predictive compliance through trend analysis.
- Directed QMS strategies that improved inspection readiness and compliance in GMP operations.
Deputy Manager – QA QMS/Validation
SHILPA Biologicals Pvt. Ltd.
Hyderabad
09.2018 - 09.2021
- Qualification/validation leadership for clean utilities, HVAC, upstream/downstream equipment, sterilization (steam/terminal/dry heat), and VPHP.
- Managed change controls, impact assessments, deviations, and investigations; proposed and tracked CAPAs to ensure compliance and operational integrity.
- Coordinated vendors and consultants; approved design documents and validated cycle development protocols, test methods, and process simulations to support regulatory compliance.
- Led QA for greenfield DS/DP facilities including large-scale isolator technology and aseptic operations.
Assistant Manager – QA QMS
Cipla Ltd.
11.2016 - 08.2018
- Oversaw QMS and maintained compliance with SOPs, validation plans, and regulatory standards in manufacturing.
- Monitored staff performance and developed improvement plans.
- Coordinated with senior management to implement strategic plans for revenue growth.
- Trained new employees on company policies, customer service excellence, and sales techniques.
Sr. Associate – QA, Corporate Validation Group
Mylan Laboratories Ltd. (Pfizer)
06.2015 - 11.2016
- Corporate validation support and lifecycle approach per ASTM E2500; qualification of critical systems and processes.
- Reviewed work of junior associates, identified knowledge gaps, corrected mistakes and recommended changes to prevent future mistakes and improve performance.
- Trained junior associates in proper procedures, team policies and strategies for success.
- Managed data collection, visualisation and reporting for projects of different scale and applications.
Sr. Officer – QA Documentation
Pavan Drugs & Chemicals
04.2010 - 06.2013
Education
MSc - Microbiology
Sathyabama University
Chennai, IN-TNSkills
- QMS governance
- Quality management
- Process optimisation alliance
- GMP readiness
- CAPA oversight
- CAPA management
- Audit oversight
- Risk management
- Risk evaluation
- Predictive compliance
- Data Integrity
- Validation
- Change Control
- Impact Assessment
- Inspection preparedness
- Aseptic Operations
- Isolator Operations
- Clean Utilities
- HVAC
- Sterilisation
- APQR
- Operations Management
- Project coordination
- Audit oversight
- Change leadership
- People Leadership
- Talent Development
- Team management
- Training design
- Operational integrity
- Decision-making
- Decision-making
- CAPA management
Languages
English
Hindi
Telugu
Custom Section
https://www.linkedin.com/in/mraghuvamshikrishna?utm_source=share_via&utm_content=profile&utm_medium=member_android
Interests
Interested in collection of coins, currencies in various formats
Timeline
Sr. Manager – QA QMS (SME), QMS Lead
CuraTeQ Biologics Pvt. Ltd.
09.2021 - Current
Deputy Manager – QA QMS/Validation
SHILPA Biologicals Pvt. Ltd.
09.2018 - 09.2021
Assistant Manager – QA QMS
Cipla Ltd.
11.2016 - 08.2018
Sr. Associate – QA, Corporate Validation Group
Mylan Laboratories Ltd. (Pfizer)
06.2015 - 11.2016
Sr. Officer – QA Documentation
Pavan Drugs & Chemicals
04.2010 - 06.2013
MSc - Microbiology
Sathyabama University