GNANA TEJA RAVI
Siruguppa
Summary
Results-driven professional with a proven track record in driving innovation and adopting emerging technologies within the pharmaceutical and biotech industries. Skilled at fostering strong relationships with teams and cross-functional groups to promote collaboration and achieve common goals. Experienced in leading teams, optimizing processes, and aligning strategies with business objectives to enhance efficiency and performance. Creates a flexible and collaborative work environment to effectively address challenges. Personable, organized, and adept at problem-solving, with expertise in team dynamics, project management, data analysis, and process improvement. Committed to driving team success through the implementation of strategies that enhance overall performance.
Overview
15
15
years of professional experience
4
4
Languages
Work History
Associate Manager (Microbiology)
SYNGENE INTERNATIONAL PVT LTD
07.2023 - Current
- Company Overview: Contract research & manufacturing services
- Initiated process improvements based on thorough analysis of internal operations data resulting in enhanced productivity levels.
- Led team meetings regularly to discuss progress updates, identify challenges or roadblocks, and provide guidance towards successful project completion.
- Collaborated closely with senior management on strategic planning efforts, aligning departmental goals with overarching company objectives.
- Mentored junior team members, contributing to their professional growth and skill development.
- Successfully managed multiple high-priority tasks simultaneously while maintaining strict deadlines ensuring optimal resource allocation.
- Established strong relationships with key stakeholders, fostering collaboration and mutual support.
- Streamlined processes for increased efficiency and cost savings within the department.
- Proactively identified areas for improvement, implementing solutions that led to significant cost savings.
- Conducted regular performance evaluations of staff members, providing constructive feedback and identifying areas for growth.
- Quality Management Systems QMS: Ability to implement and maintain effective QMS to support continuous improvement
- Data Analysis and Metrics: Analyzing data to monitor driven decisions for improvement
- Leadership and Team Management: Inspiring and guiding a team to achieve quality goals and fostering a culture of quality consciousness
- Change Management: Managing changes in processes, technology, or regulations while ensuring the quality
- Deviation management: responsible to identify, document, investigate from established procedures or specifications to enhance efficiency and quality
- Risk Management: Identifying and mitigating potential risks in processes and products to prevent quality issues
- Involved in planning of Microbiological validations and ensuring the execution of the same
- Allotted daily work to the Microbiologists and setting up of Microbiology Laboratory
- Prepared/reviewed SOP’s, standard testing procedures and performed validation of protocols
- Widely involved in preparing and implementation of Annual Calibration Calendar for laboratory equipment’s.
Assistant Manager (Microbiology)
RECIPHARM PHARMASERVICES PVT LTD
04.2022 - 06.2023
- Company Overview: Third party manufacturing – Non sterile products
- Expertise in writing the procedures and protocol
- Expertise in microbiology laboratory instruments/equipment validations/Qualification
- Participate in self-inspection as part of compliance verification and ensure necessary corrective and preventive action
- To Ensure the timely completeness of the preventive maintenance, calibration, laboratory maintenance and breakdown maintenance of the instruments/equipment’s in microbiology laboratory
- To Initiate, review and implementation of the change controls, CAPA, Deviations, protocols, report and SOP’s
- Facilitate/ participate in the execution of the protocols in compliance to the requirements as defined in protocols
- To facilitate the daily monitoring of the temperature, differential pressure, humidity and cleanliness of the Microbiology laboratory
- Co-ordinate/ facilitate and conduct training as per the schedule/ requirement
- Preparation of the user requirement specification (URS) for the new equipment’s and software application related to microbiology Department
- Decommissioning of the Instruments/ equipment’s which are not operatable conditions.
- Commissioning of the new Instrument / Equipment’s as per the requirement of the Microbiology laboratory.
- Facilitate / Perform the Re-qualification of the equipment’s in the Microbiology laboratory.
Associate Manager (Grade – 15)
PFIZER HEALTHCARE INDIA Pvt. Ltd.
07.2019 - 03.2022
- Company Overview: Terminal Sterilization Division, Parawada, Vizag INDIA
- Well versed with Quality management system for Deviation management, CAPA management & Change management
- Preparation of the user requirement specification (URS) for the new area qualification, equipment’s and software application related to microbiology Department
- Change initiation, document preparations related to area qualifications, equipment qualification and computer system validation related activities of microbiology department
- Quality risk management (QRM) preparation for the area qualification, equipment qualification, Facility modification, Vendor qualification related to microbiology department
- Designing of the recipe & loads, load development and qualification for the steam sterilizer, Isolator & Incubator
- Responsible to identify the continuous improvement projects with the procedure and simplification of the procedures
- Handling of the training related activities - preparation of the training risk assessment, design of the curricula, preparation of the training questionnaire
- Responsible for assistance for internal, external (Regulatory) and vendor related audits.
Senior Team Member (R1A)
Dr Reddys Laboratories Ltd
11.2017 - 06.2019
- Company Overview: Sterile formulation division (Complex molecules) – FTO 9
- To prepare and review the microbiology tests methods, development reports, validation protocols, miscellaneous study protocols and specification for API, In-process & Finished products
- Management of day to day microbiology activities
- Initiate, review, assessment and closure of quality system documents like change control, incidents & CAPA related to Microbiology laboratory
- Responsible for preparation and review of SOP, protocols, specifications, method of analysis, Report of analysis, analyst qualification and data reports
- Ensure the training of staff on departmental SOP, GLP, GMP and safety
- Implementation of Good Laboratory practices and online documentation
- Review of microbial analysis results for water, finished product and environmental monitoring
- Initiation and handling of microbiological OOS for the finished products, raw material and packing material
- Ensure the calibration and periodical performance qualification of equipment’s
- Review and approval of analytical method validations / transfers / verifications / feasibility study / miscellaneous study protocols and reports along with respective raw data.
Executive (E3)
Amneal Oncology Pvt Ltd.
08.2015 - 11.2017
- Company Overview: Sterile Oncology Unit, Jadcherla
- Responsible for procurement, management of inventory in microbiology laboratory
- Responsible to perform environmental monitoring program in microbiology and Production area
- Responsible to involve in the aseptic process simulation and inspection of the media filled vials for simulation
- Responsible to provide the training on the Aseptic techniques & Process simulation activity
- Responsible to prepare the trend analysis for environmental monitoring & Water analysis
- Responsible for preparation of the media, maintenance of dehydrated and prepared media stocks, and sterilization of media accessories
- Responsible for maintenance for the master cultures, sub – culturing and culture preparation
- Responsible to perform the miscellaneous studies related to microbiology laboratory department
- Responsible to perform the method validation for the raw material, in – process samples and finished products
- Responsible to perform Bacterial endotoxin test, LBPC Analysis, BI Enumeration and CCIT
- Responsible to initiate, review, assessment and closure of change control related to Microbiology laboratory.
Officer (O1)
India immunologicals Ltd.
04.2014 - 07.2015
- Company Overview: Animal Health Division, Gachibowli, Hyderabad
- Responsible to perform environmental monitoring program in formulation & upstream, downstream manufacturing areas
- Responsible to perform water sampling and analysis of Water for microbial Analysis and trend analysis
- Responsible to performed bacterial endotoxin test for Water, Raw Material and Finished Products with Method validation
- Responsible to prepare the media, maintenance of dehydrated and prepared media stocks
- Responsible to involve in the aseptic process simulation and inspection of the media filled vials for simulation
- Responsible to perform the daily observation of the sterility samples
- Responsible to prepare the microbiology laboratory for 5S practice.
Executive
Zenotech Laboratories Ltd.
06.2013 - 03.2014
- Company Overview: Human Biologics Division, Turkapally, Hyderabad
- Responsible to performs environmental monitoring program in formulation & upstream, downstream manufacturing areas
- Responsible to prepare media used in the microbiological testing of bulk pharmaceutical raw materials, In Process and Finished products
- Responsible to perform the bioburden and Microbial enumeration testing of raw material and in-process samples
- Responsible to Perform Growth Promotion Testing, Subculture and prepares culture Suspension
- Responsible to perform Sterility analysis.
Executive (E2)
Aurobindo Pharma Ltd. – Unit - XII
01.2010 - 05.2013
- Company Overview: Beta - Lactam Division, Bachupally, Hyderabad
- Responsible to perform the Microbial enumeration test for Raw material, In-process and finished product
- Responsible to perform environmental microbial monitoring of Class 100, Class 10000, Class 100000, clean room Validation, documentation and Trending Analysis
- Responsible to perform water sampling and analysis of Water for microbial Analysis and trend analysis
- Responsible for Culture maintenance and culture suspension preparation
- Responsible to performed bacterial endotoxin test for Water, Raw Material and Finished Products
- Responsible to revise the Standard operating procedure related activity performed
- Responsible to involve in the aseptic process simulation and inspection of the media filled vials for simulation
Education
M. Sc - Micrbiology
Gulbarga University
B.Sc - Biotechnology
Gulbarga University
Skills
Microbial Techniques
Softwareapplicationshandled
- GQTS (Trackwise system)
- PDOC’s
- SAP FIORI
- SAP
- DOCHUB
- Caliber LIMS
- DMS
- QAMS
- Nichelon
Personal Information
- Date of Birth: 05/29/86
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Disclaimer
I hereby declare that the information furnished here is correct and true to the best of my knowledge.
Regulatoryauditsfaced
- USFDA
- ANVISA
- FIMEA
- MHRA
- TGA
- Health Canada
- Uganda
- SAHPRA (South Africa)
- SFDA (Saudi Arabia)
- Kenya
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Associate Manager (Microbiology)
SYNGENE INTERNATIONAL PVT LTD
07.2023 - Current
Assistant Manager (Microbiology)
RECIPHARM PHARMASERVICES PVT LTD
04.2022 - 06.2023
Associate Manager (Grade – 15)
PFIZER HEALTHCARE INDIA Pvt. Ltd.
07.2019 - 03.2022
Senior Team Member (R1A)
Dr Reddys Laboratories Ltd
11.2017 - 06.2019
Executive (E3)
Amneal Oncology Pvt Ltd.
08.2015 - 11.2017
Officer (O1)
India immunologicals Ltd.
04.2014 - 07.2015
Executive
Zenotech Laboratories Ltd.
06.2013 - 03.2014
Executive (E2)
Aurobindo Pharma Ltd. – Unit - XII
01.2010 - 05.2013
B.Sc - Biotechnology
Gulbarga University
M. Sc - Micrbiology
Gulbarga University
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