G. Tirumal reddy
Rogers,AR
Summary
Seeking a challenging and rewarding opportunity with an organization of repute which recognizes and utilizes true potential while nurturing analytical and technical skills.
Overview
7
7
years of professional experience
Work History
Intern
Glenmark pharmaceutical ltd
05.2023 - 08.2023
- Having Internship experience on Validation from Glenmark pharmaceutical ltd
- Involved in managing and planning multiple projects, Perform validation testing and observed test scripts and document results
- Working and Observing of cGMP’s, GDP’s and regulatory requirements as related to qualification and validation activities (IQ/OQ/PQ)
- Worked on Microsoft Word, Windows, Excel, Power Point, and Statistical tools such as Minitab/Jmp
- Worked on assessing risk assessments to identify potential risks associated with equipment, processes, and systems
- Worked on Ensuring that validation activities to comply with regulatory requirements, industry standards, and company policies
- Stay current with industry trends and regulatory changes
- Worked with a team and collaborated with members working with groups and maintained Attention at all times.
Executive
INDIAN IMMUNOLOGICALS LIMITED
01.2017 - 07.2022
- I have 5.7 year’s experience in Sterile Formulation and Filling activities
- Operation of vial washing machine and tunnel machine, filling machine, autoclave, DHS, integrity machine and lyophilizer
- Issuance of material requisition slips for primary and secondary packing materials to stores and work order for timely maintenance of machines and facility
- Supervision of cleaning activities
- Training and development of Production helpers as per SOPs
- Preparations for filling operations, assembly and sterilization of Ballast vessel and other accessories
- Ensure controlled state of manufacturing facility by adherence to cGMP hygiene and gowning procedures
- To ensure/carryout Material movement as per approved process flow and layout
- Intimation of any equipment breakdowns to engineering and follow up of the same till the completion
- Receipt and reconciliation of Filling materials from store and to maintain all the related documents for material receipts
- Supervising Mss, Fss, Blending and filling, activities as per BMR
- Involve in reviewing of SOP’S, and BMR
- Online completion of the documentations, evaluation prior to submission to QA
- Involve in process and aseptic process simulation activities and reviewing related documents
- Communication with cross functional departments to complete the activities in time
- Involved in writing protocols and reports, and testing equipment, processes and methodology to see if drug meets pre-defined criteria
- Involved in various validation activities in performing Autoclave validation, Vial washing machine, Tunnel.
Education
Master of Science - Chemistry
University of New Haven
West Haven, CT12.2023
Skills
- Project restructuring
- Professionalism and Etiquette
- Initiative
- Team Collaboration
- Operations Support
- Research and analysis
- Problem-Solving
- Quality Control
- Audit reporting
Accomplishments
- Successfully faced Regulatory Audits and several Internal Audits.
- Internship experience on Validation in Glenmark pharmaceutical limited(Monroe, North Carolina).
- Audits faced: National regulatory authority (CDL, DCGI, CDSCO) Euthiopian food, medicine, healthcare administration and control authority. Medicine control authority of Zimbabwe. Food and Drug Administration of Philipines. Food and Drug Administration of Uganda.
Behavior Skills
- Self motivated with the ability to thrive in a fast paced environment.
- Achievement oriented with very good communication and interpersonal skills.
- Carries a positive outlook with an ability to work across professional and status boundaries.
- A good team player with the ability to lead a team.
Timeline
Intern
Glenmark pharmaceutical ltd
05.2023 - 08.2023
Executive
INDIAN IMMUNOLOGICALS LIMITED
01.2017 - 07.2022
Master of Science - Chemistry
University of New Haven
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