Vinay Kumar Josyula
Hyderabad
Summary
Dynamic Quality Assurance professional with extensive experience at Eugia Pharma Specialties LTD, excelling in QMS activities and CAPA implementation. Proven expertise in risk assessment and internal audits, complemented by strong interpersonal skills and a commitment to continuous improvement. Adept at driving quality initiatives and ensuring compliance with GMP standards.
Overview
12
12
years of professional experience
Work History
Assistant Manager – Quality Assurance
Eugia Pharma Specialties LTD
Hyderabad
07.2024 - Current
- Reviewed non-conformances, OOS, OOT investigations, and CAPA to ensure compliance and drive corrective actions.
- CAPA implementation and effectiveness checks.
- Review of Validation deliverables such as validation plans, protocols & qualification documents.
- Change management i.e., review and approval of change controls.
- Implemented quality risk management strategies to identify and mitigate potential issues.
- Prepared trend reports and annual product quality reviews (APQR) to support data-driven decision-making and regulatory compliance.
- Knowledge of root cause analysis by using various Tools like i.e. Six-M Framework (fishbone), Brainstorming, 5- WHY technique & Human Errors evaluation
- Conducted internal audits according to the schedule.
- Maintained GMP compliance according to regulatory requirements and prepared for audits.
- Collaborated with cross-functional teams to implement quality improvement initiatives, enhancing overall product quality.
Senior Analyst – Global Stability
Endo India PAR Formulations
Chennai
09.2022 - 07.2024
- Review of Validation deliverables such as validation plans, protocols & qualification documents.
- Initiated and reviewed change controls, ensuring compliance with regulatory standards.
- Led QMS activities including investigations, deviations, and CAPA.
- Preparation, review and approval of SOPs’
- Knowledge of root cause analysis by using various Tools like i.e. Six-M Framework (fishbone), Brainstorming, 5- WHY technique & Human Errors evaluation
- Responsible for maintaining QC compliance as per regulatory requirements, Audit preparedness
- Conducted training in QC lab and coordinated software training for users to enhance operational proficiency.
- Updated SLT members on status of investigations, qualifications, and validations during daily meetings.
Quality Control Professional
Sanofi Healthcare India Pvt. Ltd.
India
09.2019 - 09.2022
- Method validation for raw materials testing (technology transfer), Cleaning validation (minimal), Gap assessment & preparation of SOPs..
- Conducted laboratory equipment and instrument qualifications (IQ, OQ, PQ) testing and executed post-implementation reviews.
- Reviewed and approved SOP and STP revisions.
- Preparation and review of analytical documents per regulatory standards.
- Executed data backup and audit trail verification for standalone computerized systems.
- Conducted QMS activities using Trackwise - Quality tracking system (OOS & OOT investigations, incidents, deviations/non-conformances, CAPA).
- Led daily +QDCI/standup meetings.
- Contributed to the development of standard operating procedures (SOPs) for LIMS usage and data handling.
Senior Chemist - Quality Control
Mylan Laboratories Ltd.
Hyderabad
11.2017 - 09.2019
- Preparation of SOPs, Validation protocols, Validation plans.
- Involved in New instrument/equipment Qualifications per GAMP5 guidelines.
- Responsible for calibrations and maintenance of laboratory instruments and equipment.
- Instruments handled: HPLC, GC, FT-IR, UV-spectrophotometer, KF titrator, SOR, Melting Point apparatus, Dissolution apparatus.
Officer - Quality Control
Pfizer
Visakhapatnam
09.2015 - 10.2017
- Responsible for daily equipment calibrations for QC testing.
- Finished product testing & documentation.
- Responsible for inventory of laboratory standards & reagents.
- Participated in QMS activities– incidents/deviations.
Quality Control Professional
Acacia Life Sciences
Visakhapatnam
01.2015 - 08.2015
- Responsible for Sampling of finished products, intermediates, raw materials.
- Involved in testing & documentation of finished products, intermediates, raw materials.
Education
Master of Science - Chemistry
Acharya Nagarjuna University
Guntur, Andhra Pradesh, India01-2016
Bachelor of Science - Maths, Physics, Chemistry
Andhra University
Visakhapatnam, Andhra Pradesh, India01-2014
Skills
- Quality assurance
- QMS
- CAPA
- Investigations
- Quality control testing
- Validation Technology
- GMP procedures
- Change control
- Change management
- GxP Compliance
- Risk assessment
- QRM
- Internal audits
- Data Integrity
- Data analysis
- Quality tools
- Process Improvement
- Root Cause Analysis
- GAMP5
- Regulatory Updates
- Interpersonal skills
- Teamwork
- Leadership
- Leadership
Timeline
Assistant Manager – Quality Assurance
Eugia Pharma Specialties LTD
07.2024 - Current
Senior Analyst – Global Stability
Endo India PAR Formulations
09.2022 - 07.2024
Quality Control Professional
Sanofi Healthcare India Pvt. Ltd.
09.2019 - 09.2022
Senior Chemist - Quality Control
Mylan Laboratories Ltd.
11.2017 - 09.2019
Officer - Quality Control
Pfizer
09.2015 - 10.2017
Quality Control Professional
Acacia Life Sciences
01.2015 - 08.2015
Master of Science - Chemistry
Acharya Nagarjuna University
Bachelor of Science - Maths, Physics, Chemistry
Andhra University