Ravi Ramamoorthy
Bengaluru
Summary
- Experienced group leader in a large CRO, specializing in production line efficiency and machine assembly. Consistently exceeds production targets while maintaining 100% quality goals.
- Quality Control professional with 15 years of experience in API, Sterile and non-sterile Formulation, and External Testing Laboratories. Proven track record of maintaining high standards and ensuring compliance with industry regulations. Skilled in conducting quality audits, implementing corrective actions, and driving continuous improvement initiatives.
- Experienced quality control professional with a strong background in analytical method validation and documentation. Skilled in adhering to regulatory requirements such as USFDA, UK-MHRA, and WHO. Seeking to leverage expertise in quality systems to drive continuous improvement.
- Experienced in Quality Control tools such as LIMS and Trackwise. Demonstrated proficiency in utilizing these tools to ensure product quality and compliance. Skilled in performing accurate data analysis and implementing effective quality control measures.
Overview
14
14
years of professional experience
Work History
Group Leader
Eurofins Biophrame Private Limied
Bengaluru
01.2022 - Current
- Led the team responsible for developing, validating, and verifying analytical methods ensuring adherence to QbD principles and regulatory requirements
- Collaborated with Key Pharmaceuticals company in India and global Company and CMOs to complete projects using various analytical techniques such as LC-MS/MS, GC-MS/MS, HPLC, Ion Chromatography across diverse formulations.
- Conducted technical investigations for nitrosamine's and Genotoxic impurities in a standardized manner, utilizing critical thinking, best compliance practices, chemical knowledge to determine root cause of Nitrosamine formation; specified CAPA related to API formulation or finished drug product manufacturing control strategy.
- Instituted quality control measures that enhanced the implementation of cGMPs regulations and compliance with industry-specific standard operating procedures.
- Responsible for providing effective support to QA and customers when addressing regulatory inquiries.
- Responsible for meeting the revenue and profit target of the site.
- Monitored execution and aided sites, when necessary, in developing thorough investigation reports.
- Where applicable, ensure the creation of broader scope investigation reports across sites and formulations (e.g., at the product family level) that identify common root causes.
- Develop and maintain an effective management infrastructure.
- Developed and maintained tools, procedures, and templates for nitrosamine's related investigations at multiple sites
- Created project reporting tools and defined metrics for Analytical investigations to ensure effective, routine stakeholder communication.
- Worked successfully with diverse group of coworkers to accomplish goals and address issues related to our products and services.
- Identified needs of customers promptly and efficiently.
- Approached customers and engaged in conversation through use of effective interpersonal and people skills.
- Collaborated closely with team members to achieve project objectives and meet deadlines.
Senior Manager
ALS Testing Services India Private Limited
Bengaluru
09.2018 - 01.2022
- Accountable to lead the development and validation of established and novel analytical test methods for the API & Formulation Products.
- Involved in regulatory audit (US-FDA, WHO, and ISO) and customer audits.
- Monitored and reviewed laboratory equipment and facilities on a quarterly basis and proposed improvements and recommendations.
- Fostered a team effort approach and encouraged greater individual responsibility among the chemists, improving efficiency in the Laboratory.
- Support the setup of the QC department for the continuation of the analytical testing for clinical trial materials, commercial supply, and stability studies.
- Ensure all methods are validated and performed in the QC GMP labs in compliance with regulatory standards and adhere to data integrity requirements.
- Planning and allocation of resources, materials, and scheduling of equipment for maximum utilization of production facilities and personnel.
- A dynamic professional experience in LIMS software and computer system validation. Reviewing and approving GMP documentation, e.g. SOPs, protocols, and reports, regulatory as required. Independently determines general approach and specific to technical problems.
- Leading troubleshooting/out-of-specification investigations and associated quality records as required.
- Responsible for ensuring the proper investigation of the OOS, Deviation, CAPA, and Incidents, and their closure as per the timeline mentioned in the procedure.
- Ensure to achieve the monthly revenue target as per the projected budget.
Assistant Manager
SGS Life Science Services
Chennai
02.2015 - 09.2018
- Plans projects, performs, and directs daily laboratory work, analyzes results. Involved in regulatory audits (US-FDA, WHO, and ISO) and customer audits.
- Ensure the laboratory upkeep as per the Laboratory Quality Management System. Ensure Quality Control, investigate trends, and perform lab equipment calibrations.
- Coordinate with external agents to ensure on-time delivery of supplies and instruments.
- A team effort approach and encouraged greater individual responsibility among the chemists, improving efficiency in the Laboratory.
- Ensure all methods are validated and performed in the QC GMP labs in compliance with regulatory standards and adhere to data integrity requirements.
- Optimized production facilities and personnel through efficient allocation of resources, materials, and equipment scheduling.
- Successfully meet the monthly revenue goals within budget outlines.
Scientist
Biocon Limited
Bengaluru
08.2013 - 02.2015
- Prepared ICH and customer compliant method validation, transfer, and stability protocols
- Responsible for method development, method validation, and technology transfer activities like method transfers and method verifications for fermentation products.
- Responsible for analysis of large molecules (Biologic's and Biosimilars), viz. Peptides, Proteins.
- Ensure the laboratory upkeep as per the Laboratory Quality Management System.
- Analyze the raw material and finished product samples.
- Preparation of SOP and other QMS documents.
- Achieves the KPI target.
Executive
Strides Arcolab Limited
Bengaluru
09.2011 - 02.2013
- Responsible for performing method development and validation in one of the big projects of Formulations. [Liposome projects (Amphotericin B Liposome for Injection & Doxorubicin Liposome Injection)].
- Responsible for performing method development, method validation for oncology products, API, solid oral, and injection products.
- Responsible for performing and monitoring the stability study and trend.
- Responsible for method transfer activity in respective sites.
- Conducted scientific investigations and research through coordinating laboratory tests using reliable and precise data.
- Ensure the laboratory upkeep as per the Laboratory Quality Management System.
Scientist
SGS Life Science Services
Chennai
09.2010 - 09.2011
- Hands-on experience in conducting research and analysis. Equipped with in-depth knowledge of systematic laboratory protocols, tests, and techniques.
- Ensured strict and accurate conformity to methodologies in performing analyses and routine tasks. Recorded, maintained, analyzed, and interpreted results of scientific investigation and research method development.
- Achieves the KPI target.
Education
Master of Science - Biochemistry
Bharathidasan University
TamilnaduBachelor of Science - Biochemistry
University of Madras
ChennaiSkills
- Analytical method development and Validation
- Project management
- Implementation of LimS System
- Computer System Validation
- QMS implementation process
- Response to Regulatory complaints and Queries
- Maintenance Coordination
- Performance monitoring
- Lean Management
- Ability to Work Under Pressure Communication
awards And Recognition
- Star Performer award -2023 (Q1) in Eurofins
- Best team performance award- 2023 (Q1) in Eurofins
- Star Performer award -2018-2019 in ALS Testing India Private Limited
- Star Performer award -2019-2020 in ALS Testing India Private Limited
- Star Performer award -2020-2021 in ALS Testing India Private Limited
- Star Performer award -2018 in SGS Life Science
Timeline
Group Leader
Eurofins Biophrame Private Limied
01.2022 - Current
Senior Manager
ALS Testing Services India Private Limited
09.2018 - 01.2022
Assistant Manager
SGS Life Science Services
02.2015 - 09.2018
Scientist
Biocon Limited
08.2013 - 02.2015
Executive
Strides Arcolab Limited
09.2011 - 02.2013
Scientist
SGS Life Science Services
09.2010 - 09.2011
Master of Science - Biochemistry
Bharathidasan University
Bachelor of Science - Biochemistry
University of Madras
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