Summary
Overview
Work History
Education
Skills
Completed Courses
Visa Status
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Timeline
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Sridhar Reddy Gaddam

Sridhar Reddy Gaddam

Athlone

Summary

Dynamic Quality Control Team Lead with a proven track record at Almac Sciences, adept at driving continuous improvement through Six Sigma methodologies. Expert in analytical techniques like HPLC and committed to fostering team development. Successfully managed client relationships and ensured compliance with GMP and QMS, enhancing operational efficiency and quality outcomes.

Overview

17
17
years of professional experience

Work History

Quality Control Team Lead

Almac Sciences
Athlone
01.2023 - 06.2025
  • Led a team of 7 scientific analysts, consistently delivering projects on time, within budget, and to stringent quality standards, leveraging strong organizational and project management skills and Six Sigma principles for continuous process improvement.
  • Drove high-performing teams by implementing regular huddles and one-on-one meetings, leading brainstorming sessions, conducting performance reviews, and fostering professional development through excellent interpersonal and communication skills.
  • Optimize resource allocation and minimize testing turnaround times through the application of Six Sigma methodologies and the proficient use of scheduling software, like Kanbanize.
  • Manage client relationships and project communication, leading teleconferences to discuss status, results, and requirements, and adjusting lab priorities based on client needs, demonstrating strong communication and problem-solving abilities.
  • Oversaw all laboratory operations, ensuring GMP compliance, and meticulous management of OOS, OOT, Change Control, Deviation, and CAPA processes.
  • Ensured the integrity and accuracy of RM, IPPF, FP, and Stability data through meticulous review, and the release of COAs. This process involved expert analysis of results generated by diverse laboratory instruments (e.g., HPLC, GC, UV, FTIR, Karl Fischer titrators, Coulometers, and Polarimeters) and proficient use of associated analytical software.
  • Led nonconformance investigations, identifying root causes, and implementing effective corrective actions using Six Sigma problem-solving techniques.
  • Serve as the primary client and regulatory audit contact, building strong relationships, and ensuring timely resolution of audit findings.

Assistant Manager (GLP Team Leader)

Alembic Pharmaceuticals limited (Injectables)
Gujrat
02.2018 - 12.2021
  • Led a team of 6 analysts responsible for executing method validations, verifications, instrument calibrations, and data reviews, ensuring accuracy and compliance.
  • Led analytical tech transfers from R&D to commercial manufacturing; coordinated closely with QC and regulatory affairs.
  • Delivered technical training sessions to Quality Control teams on critical Protocols, Standard test procedures, SOPs and IOCPs, enhancing operational proficiency.
  • Oversaw all Quality Management System (QMS) activities, including OOS/OOC investigations, Change Control, Deviations, CAPA implementation and verification, and laboratory event reporting.
  • Collaborated cross-functionally with internal teams and external instrument service engineers.
  • Coordinated and monitored Periodic Performance Verification (PPV) for essential lab equipment (e.g., ovens, refrigerators, freezers).
  • Ensured strict adherence to Good Laboratory Practice (GLP) and Good Documentation
  • Review all Master Calibration Records.
  • Collaborate with cross-functional teams and instrument service engineers.
  • Review of analytical data and calibration records for various instruments, including: HPLC, UPLC, GC, UV, IR, Melting Point, Surfaceentiometer, Rheometer, Viscometer, Dissolution, pH, Conductivity, Karl Fisher, Coulometer, Bottle Rotating Apparatus, Polarimeter, and Density Meter.

Senior Executive –E4

Aurobindo Pharma Limited (OSD)
Jedcherla
02.2017 - 02.2018
  • Managed a team of 2 IR specialists
  • Reviewed analytical data including RM, IPPF, FP and Stability data.
  • Implemented and maintained QMS procedures
  • Ensured GLP/GDP compliance within the laboratory
  • Collaborated with cross-functional teams.

Assistant Manager

Estima Pharma Solutions LLP (OSD)
08.2014 - 01.2017
  • Successfully implemented cGMP and GDP training programs
  • Performed cleaning validation and instrument calibration (HPLC, UV, etc.)
  • Monitored GLP/GDP adherence in laboratory settings
  • Delivered comprehensive training programs on cGMP, GDP, and regulatory agency requirements to enhance operational efficiency and risk mitigation.
  • Worked in South Korea as a consultant

Quality Officer

Mylan Laboratories Limited (OSD)
01.2012 - 08.2014
  • Performed stability studies on pharmaceutical formulations, including Assay, Related Substances, and Dissolution testing.
  • Calibrated and maintained analytical instrumentation, such as HPLC, Dissolution apparatus, potentiometers, Karl Fischer titrators, and balances.
  • Monitored and enforced adherence to Good Laboratory Practice (GLP) and Good Documentation Practice (GDP) guidelines within the laboratory environment.

Management Staff

CIPLA (Golden Cross Pharma Pvt. Ltd)
Rangpo
05.2010 - 01.2012
  • Conducted comprehensive reviews of laboratory documents, including analytical reports, SOPs, and protocols.
  • Ensured adherence to Quality Management System (QMS) requirements through thorough document reviews and audits.
  • Maintained laboratory compliance with Good Laboratory Practice (GLP) and Good Documentation Practice (GDP) guidelines.

Trainee

Dr. Reddy's Laboratories Ltd.
Hyderabad
10.2008 - 04.2010
  • Actively participated in stability studies, executing critical analyses such as Descriptions, KF, LOD, DT, Dissolution, UV, and HPLC.
  • Ensured data integrity and regulatory compliance by strictly adhering to GLP and GDP guidelines throughout all documentation processes.

Education

Masters of Business Administration - PM

Dublin Business School
Dublin, Ireland
01.2023

Master of Science - Organic Chemistry

Phulsing Naik Mahavidhyalaya
M.H, India
05.2008

Bachelor of Education -

Ganguwar College of Education
MH, India
05.2004

Bachelor of Science - Botany, Zoology and Chemistry

Nalanda Degree College
Adilabad, Andhra Pradesh, India
05.2003

Skills

  • Quality Assurance and Control Principles
  • Good understanding of quality management systems (QMS)
  • Good Manufacturing Practices (GMP)
  • Regulatory frameworks (eg FDA)
  • Analytical Chemistry
  • Proficiency in analytical techniques (HPLC, UVVis, Dissolution)
  • Laboratory Operations
  • Expertise in managing laboratory equipment
  • Calibration
  • Maintenance
  • Team Leadership and Management
  • Ability to lead and develop a QC team
  • Assign tasks
  • Ensure efficient workflow
  • Problem-Solving and Decision-Making
  • Strong analytical skills
  • Identify and resolve quality issues
  • Stability Studies
  • Knowledge of drug stability studies

Completed Courses

  • Six Sigma Principles
  • Six Sigma Tools for Analyze
  • Six Sigma Tools for Define and Measure

Visa Status

Stamp-4, 2027-03-01

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  • Visa Status: Stamp-4 (Valid till 03/2027)
  • Work Permit: Stamp-4 (Valid till 03/2027)

Disclaimer

I hereby declare that the information that I have furnished is authentic, and true to the best of my knowledge.

Timeline

Quality Control Team Lead

Almac Sciences
01.2023 - 06.2025

Assistant Manager (GLP Team Leader)

Alembic Pharmaceuticals limited (Injectables)
02.2018 - 12.2021

Senior Executive –E4

Aurobindo Pharma Limited (OSD)
02.2017 - 02.2018

Assistant Manager

Estima Pharma Solutions LLP (OSD)
08.2014 - 01.2017

Quality Officer

Mylan Laboratories Limited (OSD)
01.2012 - 08.2014

Management Staff

CIPLA (Golden Cross Pharma Pvt. Ltd)
05.2010 - 01.2012

Trainee

Dr. Reddy's Laboratories Ltd.
10.2008 - 04.2010

Masters of Business Administration - PM

Dublin Business School

Master of Science - Organic Chemistry

Phulsing Naik Mahavidhyalaya

Bachelor of Education -

Ganguwar College of Education

Bachelor of Science - Botany, Zoology and Chemistry

Nalanda Degree College
Sridhar Reddy Gaddam