Ummareddy RamaKrishna Reddy
Hyderabad
Summary
- An accomplished pharmaceutical quality professional with 12 years of extensive experience in developing and implementing comprehensive quality programs resulting in significant reductions in product defects and customer complaints. Skilled in collaborating with cross functional teams to identify and resolve the quality issues, improving product reliability, customer satisfaction ratings and regulatory compliance.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Senior Manager
Vidgas Science and Technologies Pvt. Ltd
06.2024 - Current
Currently working in ‘Vidgas Science and Technologies Pvt. Ltd’ as ‘Senior Manager’ from June 2024.
Deputy Manager
Neuland Laboratories Limited
06.2021 - 05.2024
Worked at ‘Neuland Laboratories Limited’ as ‘Deputy Manager’ from June 2021 to May 2024.
Asst. Manager
Hy-Gro Chemicals Pharmtek Pvt. Ltd
06.2020 - 06.2021
Worked at ‘Hy-Gro Chemicals Pharmtek Pvt. Ltd’ as ‘Asst. Manager’ from June 2020 to June 2021.
Junior Manager
Neuland Laboratories Limited
01.2017 - 06.2020
Worked at Neuland Laboratories Limited as ‘Junior Manager’ from January 2017 to June 2020.
Team Member
Dr. Reddy’s Laboratories Limited
12.2013 - 01.2017
Worked at ‘Dr. Reddy’s Laboratories Limited’ as ‘Team Member’ from December 2013 to January 2017.
Education
MBA - Total Quality Management
(Pursuing)
Master of Science - Organic Chemistry
05.2015
- Final Grade: 78%
Bachelor of Science - Mathematics, Physics, and Chemistry
05.2013
- Final Grade: 97%
Skills
- Establish, implement, and maintain an effective QMS in compliance with ICH Q7, CGMP, FDA, EMA, and other applicable regulatory guidelines
- Ensure continuous improvement through QMS reviews and effectiveness checks
- Ensure all activities comply with National (eg, CDSCO) and International regulations (USFDA, EU-GMP, TGA, PMDA, etc)
- Lead regulatory inspections, customer audits, and internal GMP audits and responses and follow-ups for regulatory findings and observations
- Oversee implementation and maintenance of the Quality Management System (QMS)
- Final authority on API batch release—review batch records, in-process checks, and analytical data
- Expert in comprehensive investigations on product failures
- Investigating the Non-conformities with proper investigation tools, for Root cause analysis (RCA); Ishikawa / Fishbone diagram, why-why analysis, and Brainstorming
- Analytical Method Development, Validation, Transfer, and Verification activities
- Overseeing the effective application of GMP, GDP, and GLP protocols
- Good Knowledge on CSV, GAMP5, EU Anne-11 and 21 CFR Part-11 activities
- Handling of PPQ, Cleaning, Transportation, and homogeneity Validation activities
- Assessment of technology transfer processes
- Evaluate and approve certificates of analysis (CoA), analytical reports, and ensure compliance with pharmacopoeia and customer specifications
- Qualified CGMP trainer, Internal Auditor, CQI/IRCA auditor, and participated in self-Inspections and external audits
- Experience in successfully handling different regulatory audits like USFDA, CFDA, WHO, CDSCO, EDQM, TGA, ANVISA, and various Internal Audits
- Good Knowledge of Vendor Qualification activities
- Reviewing and Approving APQR and ensuring the CpK is within acceptable limits
- Analytical document evaluation for operational scalability
- Strong analytical and problem-solving skills
- Excellent leadership and interpersonal skills
- Strong communication and report writing abilities
- Investigation Team lead (SIT)
- Qualified Trainer and Auditor
- Expert in Batch Release activities
- Expert in Audit Management Systems
- Communication
- Detail-oriented
- Adaptable
- Open to learning new techniques
- Time management
Certification
- 2020 - ISPE certification on Cleaning Validation Lifecycle-Application, Methods, and Controls
- 2021 - GAMP5
- 2021 - ISO 9001:2025 Certified Internal Auditor
- 2022 - Lean Six Sigma Green Belt
- 2024 - CQI/IRCA Certified Auditor
- 2024 - Professional in Revised Schedule-M
Accomplishments
- Awarded as Best Employee of the Year 2014 in Dr. Reddy’s Laboratories.
- Best Individual Excellence Award in the Year 2022 in Neuland Laboratories Ltd.
- Selected as GMP coordinator and Head of Compliance team to increase the GMP environment in new joiners in Neuland Laboratories Ltd.
COMPENSATION SUMMARY
- Current CTC: 14.00 Lakh/Annum.
- Expected CTC: As per the company norms.
- Notice Period: 60 days
Disclaimer
I hereby declare that the above information is true to the best of my knowledge.
Place: Hyderabad
Date:
LANGUAGES
English : Proficient
Telugu : Proficient
Hindi : Proficient
Timeline
Senior Manager - Vidgas Science and Technologies Pvt. Ltd
06.2024 - Current
Deputy Manager - Neuland Laboratories Limited
06.2021 - 05.2024
Asst. Manager - Hy-Gro Chemicals Pharmtek Pvt. Ltd
06.2020 - 06.2021
Junior Manager - Neuland Laboratories Limited
01.2017 - 06.2020
Team Member - Dr. Reddy’s Laboratories Limited
12.2013 - 01.2017
BITS PILANI - MBA, Total Quality Management
Acharya Nagarjuna University - Master of Science, Organic Chemistry
Andhra Loyola College - Bachelor of Science, Mathematics, Physics, and Chemistry
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