Prabhudev S M
NELAMANGALA
Summary
Seeking a challenging position in a reputed organization where I can learn new skills, expand my knowledge, and leverage my learnings.
Overview
5
5
years of professional experience
8075
8075
years of post-secondary education
Work History
Corporate Validation (QA)- Sr.Associate
Viatris
Bangalore
11.2022 - Current
- To Perform Qualification of Below Utilities & Equipments as per regulatory requirements:
- Steam Sterilizers (Autoclave & Terminal Sterilizer)
- Manufacturing Tank & Bulk Holding Tank
- Lyophilizer
- Tunnel Sterilizers
- Sterility Testing Isolator
- Vial Washing, Vial Filling, Sealing & Capping Machine
- PFS Filling Machine
- Air Handling Units
- Laminar Air Flow Units
- Purified Steam Generation System
- Purified Water generation System
- Building Management System
- Environmental Monitoring System
- Compressed Air & Nitrogen Air Gases
- X-Ray Inspection System
- Serialization and Aggregation System
- Temperature Mapping Study (Equipment & Area)
- (Mylan laboratories Limited)
- Preparation of Protocols & Load patterns
- Preparation of trends related to Qualifications.
- Review of Microbial trend reports.
- Computer System Validation (CSV) activities for GMP-critical computerized systems, ensuring
- compliance throughout the system lifecycle.
- Author & review(URS), Validation Plans, IQ/OQ/PQ protocols, Risk Assessments, and Validation
- Summary Reports in line with regulatory expectations.
- Independently execute Equipment Qualification (IQ, OQ, PQ, RQ) for manufacturing equipment, utilities,
- and critical systems, ensuring adherence to approved protocols and acceptance criteria.
- Perform risk-based validation in accordance with GAMP 5 and SDLC methodologies, including vendor
- assessment and system categorization.
- Ensure strict compliance with cGMP, GxP requirements, 21 CFR Part 11, EU Annex 11, Data Integrity
- (ALCOA+) principles, and applicable regulatory guidelines.
- Review and verify audit trails, electronic records, electronic signatures, access controls, and
- backup/restore procedures for compliance.
- Support change control, deviation handling, impact assessment, and CAPA implementation related to
- validated systems.
- Assisted in the Preparation & execution of IQ/OQ/PQ/RQ activities for manufacturing equipment,
- utilities, and computerized systems, ensuring accurate documentation and protocol adherence.
- Supported Computer System Validation (CSV) activities such as test case preparation and execution,
- traceability matrix (RTM) creation, and audit trail review.
- Contributed to Periodic Reviews, user access management, password policy verification, and data
- integrity compliance for GMP systems.
- Worked closely with Production, Engineering, QA, and IT teams to ensure smooth execution of validation
- activities and regulatory compliance.
- Preparation of SOPs in compliance with regulatory guidelines.
QA-Trainee Executive
Somerset therapeutics Limited
Bangalore
12.2021 - 11.2022
- Conducted routine in-process inspections and audits to monitor manufacturing processes and ensure compliance with GMP and company standards.
- Identified and investigated deviations and non-conformances, implementing corrective and preventive actions (CAPAs) to address root causes.
- Collaborated closely with production teams to resolve quality issues and improve process efficiency.
- Participated in cross-functional teams to implement process improvements and enhance product quality.
- Preparation and review of BMR, BPR by using standard template.
- Actively involved in managing & executing batches for drug product development, supporting timelines for the launch of new pharmaceutical products.
- Responsible for managing the technology transfer of new pharmaceutical products from development to commercial production, ensuring process scalability, regulatory compliance, & operational readiness.
- Managed ongoing assessment of product quality & stability throughout the product lifecycle, facilitating continuous improvement & regulatory adherence.
- Successfully executed engineering batch trials & feasibility assessments, optimizing process suitability & improving operational performance.
- Engaged with cross-functional teams to uphold quality & stability throughout the product development lifecycle.
- Basic understanding of Change Controls, GDP, cGMP & Deviation Management within regulated environments.
- Troubleshot product transfer challenges, implementing corrective actions to minimize delays.
- Worked closely with Formulation Development colleagues to track product quality metrics & stability trends, ensuring compliance with regulatory & internal standards.
- Contribute to the provision of a safe working environment by complying with regulations.
- (Wintac Limited)
QA-Officer
Karanataka Antibiotics and Pharamceutical Limited
Bangalore
06.2021 - 11.2021
Education
Master of Pharmacy -
Priyadarshini College of Pharmacy
Bachelor of Pharmacy -
Vivekananda college of Pharmacy
D pharmacy -
Vivekananda college of Pharmacy
PUC -
Sri Vishnavi Chethana
Tumkur 02.2012 - 01.2014
SSLC -
Sri Basaveshwara English high school
Skills
- Operation of E-Val Pro & E-Val Flex Validator System
- Quality Management System
- Proficient and experienced in assessing MS office
Documentation
- Preparation of Protocols & Load patterns
- Preparation of trends related to Qualifications.
- Review of Microbial trend reports.
Audit Exposure
- USFDA
- ANSM
Disclaimer
I hereby declare that all the above furnished details are true to the best of my knowledge.
Areas Of Interest
- Pharmacovigilance & Drug Safety
- Adverse Event case Management
- Safety data Analysis & Signal Detection
- Regulatory Compliance & Quality System
- Regulatory Affairs
Personal Information
- Father's Name: Mallikarjunappa
- Date of Birth: 10/08/95
- Gender: Male
- Nationality: Indian
- Marital Status: Single
Languages
English
Advanced
C1
Timeline
Corporate Validation (QA)- Sr.Associate
Viatris
11.2022 - Current
QA-Trainee Executive
Somerset therapeutics Limited
12.2021 - 11.2022
QA-Officer
Karanataka Antibiotics and Pharamceutical Limited
06.2021 - 11.2021
PUC -
Sri Vishnavi Chethana
02.2012 - 01.2014
Master of Pharmacy -
Priyadarshini College of Pharmacy
Bachelor of Pharmacy -
Vivekananda college of Pharmacy
D pharmacy -
Vivekananda college of Pharmacy
SSLC -
Sri Basaveshwara English high school