Vishnu Vardhan Gujjula
Hyderabad
Summary
Detail-oriented and resultsdriven Quality Assurance professional with over 5 years of experience in the sterile pharmaceutical industry, specializing in Quality Management Systems (QMS). Proven track record in managing deviations, CAPAs, change control, internal audits, and GMP compliance. Strong knowledge of regulatory standards including USFDA, MHRA, EU GMP, and ICH Q9 & Q10. Excellent communication, documentation, and leadership skills with hands-on experience in quality risk management and continuous improvement initiatives. Detail-oriented Assistant Manager offers more than extensive progressive record of accomplishment in leadership roles. Establishes clear guidelines and enforces consistent policies to keep staff satisfied and on-target to achieve important objectives. Excellent relationship-building, multitasking, and decision-making skills.
Overview
12
12
years of professional experience
Work History
Assistant Manager - Quality Assurance (QMS)
Gland Pharma Ltd.
Hyderabad
12.2020 - Current
- Manage and monitor QMS processes including deviation investigations, CAPA effectiveness, change controls, and risk assessments in a sterile injectable manufacturing facility.
- Led the implementation of electronic QMS software (e.g., TrackWise) enhancing document control and workflow efficiency.
- Conduct trend analysis of recurring quality issues and support continuous improvement projects to reduce deviations by 30%.
- Coordinated investigations and root cause analysis (RCA) using tools like 5 Whys and Fishbone Diagram.
- Prepare and face regulatory audits and customer inspections; contributed to successful USFDA and EU audits with zero critical observations.
- Managed controlled documents, change requests, and periodic quality reports.
- Assisted in internal audits and follow-ups for CAPA closure in compliance with timelines.
- Train cross-functional teams on GMP, QMS procedures, and data integrity principles.
- Supported QMS documentation, including drafting, reviewing, and controlling SOPs, validation protocols, and quality agreements.
- Ensured compliance with ISO 13485 and EU GMP for sterile dosage forms.
Sr.Executive - Production QMS (OSD)
MSN labs.
Hyderabad
10.2018 - 01.2020
- Coordinate and ensure compliance with QMS activities on the production floor (granulation, compression, coating, capsule filling, and packaging).
- Responsible for timely review and reconciliation of BMRs/BPRs, ensuring data integrity and completeness.
- Lead and document deviation investigations, raise CAPAs, and support their implementation and effectiveness checks.
- Maintain change control documentation related to equipment, material, and process changes in production.
- Ensure compliance to SOPs and facilitate SOP revision, training, and implementation.
- Participate in internal audits, and provide production-related documents during regulatory inspections.
- Conduct line clearance and ensure readiness of area and equipment for batch start-up as per GMP.
Production QMS Executive - OSD Manufacturing
Hetero labs.
Hyderabad
02.2013 - 09.2018
- Ensure compliance with QMS protocols during granulation, compression, coating, and packing activities in the OSD production area.
- Review Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) for completeness and GMP compliance.
- Perform line clearance checks, equipment status verification, and maintain logbooks per SOP requirements.
- Assist in documenting deviations, tracking CAPAs, and supporting timely closure in coordination with QA.
- Facilitate SOP training, monitor adherence, and propose revisions as needed based on shop floor practices.
- Support internal and external regulatory inspections by maintaining audit-ready documentation and production area compliance.
Education
M.Pharmacy - Pharmacy
Balaji institute of pharmaceutical science
Narsampet, TG01.2014
B.PHARMACY - Pharmacy
Sri Kakatiya institute of pharmaceutical science
Hanamkonda, TG01.2011
Intermediate - Secondary school of Education
SVS Junior college
Hanamkonda, TG01.2006
SSC - High School
Srigurukulam vidyalayam
Narsampet, TG01.2004
Skills
- Quality Management Systems (QMS)
- Sterile Manufacturing Compliance
- Deviation & CAPA Management
- Change Control
- Risk Assessment (FMEA, HACCP)
- Audit Readiness & Support
- SOP Development & Review
- Data Integrity & Documentation
- Regulatory Compliance (USFDA, EU, MHRA)
- GMP Training & Quality Culture
- QMS Software: TrackWise
- QMS Software: Caliber QMS
- QMS Software: Caliber DMS
- Documentation Tools: MS Office Suite
- Documentation Tools: SharePoint
Personal information
- Father's Name: Rajireddy
- Mother's Name: Nagendra
- Religion: Hindu
- Date of Birth: 12/26/1988
- Nationality: Indian
- Marital Status: Married
Projects
Track wise, Caliber DMS & QMS
Languages
Telugu
First Language
English
Advanced (C1)
C1
Hindi
Upper Intermediate (B2)
B2
Timeline
Assistant Manager - Quality Assurance (QMS)
Gland Pharma Ltd.
12.2020 - Current
Sr.Executive - Production QMS (OSD)
MSN labs.
10.2018 - 01.2020
Production QMS Executive - OSD Manufacturing
Hetero labs.
02.2013 - 09.2018
M.Pharmacy - Pharmacy
Balaji institute of pharmaceutical science
B.PHARMACY - Pharmacy
Sri Kakatiya institute of pharmaceutical science
Intermediate - Secondary school of Education
SVS Junior college
SSC - High School
Srigurukulam vidyalayam
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