LAKSHMAN TEJA B
Summary
Experienced professional with 9.9 years specializing in qualification and validation processes, ensuring compliance with health, safety, and environmental standards. Proven ability to align documentation standards with global quality standards and validate qualification activities to meet pharmaceutical practices. Skilled in preparing, reviewing qualification protocols, reports, and documentation for accuracy and compliance. Additionally, adept at handling investigations, CAPA management, and change control processes. Seeking to leverage expertise in qualification and validation to enhance operational efficiency and maintain stringent quality standards within a dynamic organization.
Overview
10
10
years of professional experience
Work History
Packaging Specialist
Dr. Reddy's Laboratories (Biologics Division)
01.2023 - Current
- Prepared and reviewed Qualification protocols (IQ, OQ, PQ) in electronic validation system (eVal), ensuring compliance with global quality standards
- Developed detailed equipment qualification reports
- Created and reviewed User Requirement Specifications (URS) for new equipment
- Evaluated process validation protocols and reports for packaging, ensuring adherence to quality standards and regulatory requirements
- Process validation of electronic MBRs in MES PasX (Werum)
- Collaborated with cross-functional teams (engineering, quality assurance, production, IT) to define project requirements and qualification deliverables
- Led investigations into discrepancies and non-conformities, utilizing root cause analysis methodologies such as Fishbone Diagrams and5 Whys
- Participated in internal audits and regulatory inspections (FDA, EMA, MHRA), providing detailed explanations and evidence of investigation processes and outcomes
- Conducted risk assessments using Failure Mode and Effects Analysis (FMEA) for manufacturing processes and new equipment, identifying and mitigating potential risks
- Created and maintained comprehensive documentation, including Standard Operating Procedures, manufacturing batch records, and training materials & provided regular trainings on regulatory guidelines, GMP and GDP practices
Executive
Biocon Biologics Limited
03.2021 - 01.2023
- Execution of equipment IQ and OQ protocols
- Authored Installation Qualification, Operational Qualification and Re-Qualification protocols for new equipment and for equipment modifications
- Collaborated with cross-functional teams to define project requirements and deliverables
- Developed detailed protocols for executing KNAPP studies, tailored specifically to evaluate differences between manual and automated inspection systems
- Developed process related validation protocols that are recommended for implementation in new process and address the findings from investigations
- Addressing the non-conformities and deviation in Track wise
- Preparation of OOL trend reports and proposing the process recommendations from the trend outcome
Junior Officer
Pfizer Healthcare India Private Limited
03.2015 - 03.2023
- Managed documentation processes, ensuring that all quality-related documents are accurately maintained, updated, and compliant with Good Documentation Practices
- Assisted in preparing of Qualification protocols (IQ, OQ)
- Assisted in preparation of process validation reports for automatic visual inspection process
- Supported the change control process by helping evaluate and implement changes in processes, equipment, and procedures
- Supported the reporting and documentation of non-conformities and deviations, ensuring timely resolution and corrective actions
- Assisted in gathering and analyzing quality data to support continuous improvement initiatives and reporting to management
- Preparation of SOP's, SCI's and SOI's
Education
Bachelor of Technology - Electrical & Electronics Engineering
Sanketika Institute of Technology & Management
05.2018
Diploma - Electrical & Electronics Engineering
Sanketika Institute of Technology & Management
04.2014
Skills
- Proficient with MS Office (Word, Advanced excel, Power point, Visio)
- Leadership
- SAP, PasX, MES, eVal
- Cross-function Collaboration
- Time management aptitude
- Analytical thinking
- Problem solving
- Computerized system validations
- Strong communication skills
- Continuous improvement initiatives
- Cross-functional team collaboration
Accomplishments
- Received “Go Getter” recognition award for best performer in2022.
- Received best project award for “Harmonization of SOP's, SCI's and SOI's” in2018.
Timeline
Packaging Specialist
Dr. Reddy's Laboratories (Biologics Division)
01.2023 - Current
Executive
Biocon Biologics Limited
03.2021 - 01.2023
Junior Officer
Pfizer Healthcare India Private Limited
03.2015 - 03.2023
Diploma - Electrical & Electronics Engineering
Sanketika Institute of Technology & Management
Bachelor of Technology - Electrical & Electronics Engineering
Sanketika Institute of Technology & Management
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