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)