Sample Escalation Profile
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lakshmiprasad635Sample Escalation Profile
Uploaded by
lakshmiprasad635Nationality: Indian
Language: English, Hindi, Telugu
PROFESSIONAL EXPERIENCE SUMMARY
8 years (Production & Maintenance in Sterile Formulation Equipment and computer systems)
PROFESSIONAL EXPERIENCE
Computer system Validation, GxP and GAMP categorization and 21 CFR part 11 assessment
Well versed with Validation life cycle management, Change Management, Deviations, CAPA
and Risk Management.
Exposure on Traditional V-model and Risk based approach
Good process knowledge.
Participating in Commissioning and Qualification of Brown-field Projects (Facilities,
Equipment).
Knowledge of VMP, SLIA, System boundaries documents.
Preparation of Risk assessment documents.
Preparation of Protocols, Review, Execution and Summary Report of Equipment
Commissioning and Qualifications like QRM, FAT, Commissioning/SAT, IQ, OQ, IOQ and
PQ.
Good knowledge on regulatory guidelines and guidance documents (FDA, EU and ISPE) for
Pharmaceuticals.
Exposure of temperature mapping studies.
Breakdown and Preventive maintenance of Process, Lab equipment and automated systems.
Performing Validations for Filling line equipment, packing equipment, Autoclaves and Vessels
Review and online writing of BMR & Equipment usage logbooks.
Proficient in SAP systems of sterile manufacturing industry.
Material process and production activity execution in the SAP system.
Monitoring all the QMS (Change Controls, Deviations and CAPA) activities in engineering
department.
Preparation of investigation reports and implementing CAPAs Raising, implementation and
closing of CCFs. Attending daily meetings and executing the plans
Attending (Trouble shooting) breakdown maintenance of Sterile Injectable Equipment(Filling
Line, Autoclaves and Packing Equipment)
Performing validations for the new equipment (Vessels, Filling line equipment, Lyophilizer and
Packing Equipment).
WORK SKILLS
Application softwares: MS Office& Internet concepts.
Beginner in AutoCAD.
Technical writing and presentation experience.
Strong ability to work and manage multiple tasks within tight deadlines.
Excellent planning, technical, and interpersonal skills with the ability to identify and drive issues
to closure.
COMMISSIONING, QUALIFICATION AND VALIDATION: (FACILITY & EQUIPMENT)
Rockwell Automation software qualifications.
Categorization of Systems.
Fill Finish Line equipment
WORK EXPERIENCE/PROFILE
Feb. 2021 to present: Working as Engineer (Executive) in Indian immunologic limited at Hyderabad,
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EXPOSURE TO QUALITY AUDITS: USFDA, CDSCO, MHRA and Corporate audits
EDUCATION
B. Tech in Electrical and Electronics Engineering completed on May 2016.
Diploma in Electrical and Electronics Engineering completed on May 2012.
DECLARATION
I hereby declare that the information furnished above is true to the best of my knowledge.
Date:
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